Athersys: A Potential Stroke Therapy Monopoly On Hand

(Editors' Note: This article covers a micro-cap stock. Please be aware of the risks associated with these stocks.)

In my last article on Athersys (ATHX) I took a look at the company's clinical pipeline, competition and near-term catalysts, to make a case as to why I felt the company's shares were significantly undervalued. This Tuesday after-hours, Cytomedix (CMXI.OB), who is Athersys' main competition in the stroke therapy market, announced that it plans to halt funding for its ischemic stroke therapy after this year in order to focus on its wound care division. Considering that Athersys and Cytomedix have both been assessed by analysts as being the two main companies' with potential blockbuster stroke treatments on hand, one can't help but wonder why Cytomedix is planning to halt funding for its therapy after this years end.

The Stroke Market

Ischemic stroke, which is considered by the CDC as being the #4 leading cause of death in the world following heart disease, cancer and respiratory failure, comprises a market opportunity of approximately $30B+ annually. While dozens of attempted stroke trials have ultimately failed over the past decade, the only current FDA approved drug for stroke treatment is Genetech's Activase. Activase, which is shown to be effective in some cases, is only used by approximately 3-5 percent of the stroke patient population due to its side effect of causing potential brain hemorrhaging. Aside from Activase, the only other current treatment option for ischemic stroke patients is a surgical attempt to remove the clot, yet needless to say this is not an ideal situation.

MultiStem

While currently the drug Activase dominates the stroke treatment market, this is certain to change if either Athersys or Cytomedix's stroke therapy receives FDA approval. Athersys which is currently conducting a Phase II stroke trial for its MultiStem® therapy is expecting results in Q2 of 2014. Per reviewing Athersys' numerous scientific journal publications documenting MultiStem's efficacy, as well as reviewing the company's past trial data from MultiStem applied to Ischemic stroke, I have an extremely optimistic outlook on the company's future Phase II trial results. Per Athersys' previous data presented at The American Heart Association's Stroke Conference, the company revealed that it's MultiStem therapy reduced damage and enhanced functional recovery in animals after an ischemic stroke. Specifically documented was that after receiving Athersys' MultiStem therapy these animals' experienced improved coordination, balance, motor skills, physical strength and neurological functioning. Since MultiStem is being developed as an off the shelf product which does not need to be prepared via extracting and processing a patients own cells, it provides an extremely convenient option for treatment. Following a stroke, MultiStem is administered intravenously into a patient's blood stream where the stem cells can then be transported to the patients area of injury and begin repairing damage.

ALDH-401

Unlike MultiStem which is targeted to be administered as soon as 1 day after experiencing a stroke, Cytomedix's ALDH-401 therapy is to be administered roughly 2 weeks after experiencing a stroke. While the time lag posed by Cytomedix's therapy is clearly not as convenient, the company's ALDH-401 therapy did show efficacy in pre-clinical results. Pre-clinical data revealed a 41% improvement in motor function after receiving Cytomedix's therapy in comparison to an 11% improvement in the control group. Yet in looking at how Cytomedix's stroke therapy is formulated and administered, one can gain a quick understanding as to why it is not the most ideal approach. While MultiStem is manufactured prior to a patient being hospitalized, ALDH-401 requires that a patient have their bone marrow extracted in order for their therapy to be manufactured post stroke. Adding further discomfort is the administration of this therapy. Unlike MultiStem which is simply injected into a patient's blood stream intravenously, ALDH-401 requires that a patient undergo an intracartoid infusion procedure. While there is no reason why both therapies could not be potentially administered to the same stroke patient theoretically, it is apparent that ALDH-401 is a much more arduous therapy in nature.

Conclusion

In looking at both Athersys and Cytomedix's stem cell therapies for Ischemic Stroke, it is evident that both products have shown clinical efficacy thus far. While Athersys' Phase II trial results are expected a few months earlier than Cytomedix's, this aspect is more of a superficial one in comparison to what the companies actual trial results show. However, in considering yesterday's press release by Cytomedix stating its plans to halt funding for its stroke program after this year, one has to seriously question whether the trial will even make it to the finish line. In spite of Cytomedix's positive pre-clinical stroke data thus far, it is not a bullish sign that the company plans to halt funding for this trial after 2013 in order to focus its efforts on developing its wound care division. All aforementioned being the case, it is my opinion that Athersys would be the clear best investment in the stroke sector currently.

Disclosure: I am long ATHX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Prosensa: One Duchenne Therapy Down

In the post here the other day about Duchenne Muscular Dystrophy [DMD] I mentioned two other companies that are looking at transcriptional approaches: Prosensa (with GSK) and Sarepta. They've got antisense-driven exon-skipping mechanisms, rather than PTC's direct read-through one.

Well, Sarepta still does, anyway. Prosensa and GSK just announced clinical data on their agent, drisapersen, and it appears to have missed completely. The primary endpoint was a pretty direct one, total distance walked over six minutes, and they didn't make statistical significance versus placebo. This was over 48 weeks of treatment, and none of the secondary measures showed any signs either, from what I can see. I can't think of any way to spin this in any positive direction at all.

So drisapersen is presumably done. What does this say about Sarepta's candidate, eteplirsen? On the one hand, its major competitor has just been removed from the board. But on the other, their complete failure with such a closely related therapy can't help but raise doubts. I don't know enough about the differences between the two (PK?) to speculate, but it'll be interesting to see if Sarepta's stock zips up today, sells off, or (perhaps) fights to a draw between two groups of investors who are taking this news in very different ways.

That's the delirious fun of biotech investing. And that's just for the shareholders - you can imagine what it feels like to bet your whole company on this sort of thing.

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Glioblastoma response to anti-angiogenesis therapy revealed by new MR analysis technique

Main Category: Cancer / Oncology
Also Included In: MRI / PET / Ultrasound;  Neurology / Neuroscience
Article Date: 20 Aug 2013 - 1:00 PDT Current ratings for:
Glioblastoma response to anti-angiogenesis therapy revealed by new MR analysis technique

A new way of analyzing data acquired in MR imaging appears to be able to identify whether or not tumors are responding to anti-angiogenesis therapy, information that can help physicians determine the most appropriate treatments and discontinue ones that are ineffective. In their report receiving online publication in Nature Medicine, investigators from the Martinos Center for Biomedical Imaging at Massachusetts General Hospital (MGH), describe how their technique, called vessel architectural imaging (VAI), was able to identify changes in brain tumor blood vessels within days of the initiation of anti-angiogenesis therapy.

"Until now the only ways of obtaining similar data on the blood vessels in patients' tumors were either taking a biopsy, which is a surgical procedure that can harm the patients and often cannot be repeated, or PET scanning, which provides limited information and exposes patients to a dose of radiation," says Kyrre Emblem, PhD, of the Martinos Center, lead and corresponding author of the report. "VAI can acquire all of this information in a single MR exam that takes less than two minutes and can be safely repeated many times."

Previous studies in animals and in human patients have shown that the ability of anti-angiogenesis drugs to improve survival in cancer therapy stems from their ability to "normalize" the abnormal, leaky blood vessels that usually develop in a tumor, improving the perfusion of blood throughout a tumor and the effectiveness of chemotherapy and radiation. In the deadly brain tumor glioblastoma, MGH investigators found that anti-angiogenesis treatment alone significantly extends the survival of some patients by reducing edema, the swelling of brain tissue. In the current report, the MGH team uses VAI to investigate how these drugs produce their effects and which patients benefit.

Advanced MR techniques developed in recent years can determine factors like the size, radius and capacity of blood vessels. VAI combines information from two types of advanced MR images and analyzes them in a way that distinguishes among small arteries, veins and capillaries; determines the radius of these vessels and shows how much oxygen is being delivered to tissues. The MGH team used VAI to analyze MR data acquired in a phase 2 clinical trial - led by Tracy Batchelor, MD, director of Pappas Center for Neuro-Oncology at MGH and a co-author of the current paper - of the anti-angiogenesis drug cediranib in patients with recurrent glioblastoma. The images had been taken before treatment started and then 1, 28, 56, and 112 days after it was initiated.

In some patients, VAI identified changes reflecting vascular normalization within the tumors - particularly changes in the shape of blood vessels - after 28 days of cediranib therapy and sometimes as early as the next day. Of the 30 patients whose data was analyzed, VAI indicated that 10 were true responders to cediranib, whereas 12 who had a worsening of disease were characterized as non-responders. Data from the remaining 8 patients suggested stabilization of their tumors. Responding patients ended up surviving six months longer than non-responders, a significant difference for patients with an expected survival of less than two years, Emblem notes. He adds that quickly identifying those whose tumors don't respond would allow discontinuation of the ineffective therapy and exploration of other options.

Gregory Sorensen, MD, senior author of the Nature Medicine report, explains, "One of the biggest problems in cancer today is that we do not know who will benefit from a particular drug. Since only about half the patients who receive a typical anti-cancer drug benefit and the others just suffer side effects, knowing whether or not a patient's tumor is responding to a drug can bring us one step closer to truly personalized medicine - tailoring therapies to the patients who will benefit and not wasting time and resources on treatments that will be ineffective." Formerly with the Martinos Center, Sorensen is now with Siemens Healthcare.

Study co-author Rakesh Jain, PhD, director of the Steele Laboratory in the MGH Department of Radiation Oncology, adds, "This is the most compelling evidence yet of vascular normalization with anti-angiogenic therapy in cancer patients and how this concept can be used to select patients likely to benefit from these therapies."

Lead author Emblem notes that VAI may help further improve understanding of how abnormal tumor blood vessels change during anti-angiogenesis treatment and could be useful in the treatment of other types of cancer and in vascular conditions like stroke. He and his colleagues are also exploring whether VAI can identify which glioblastoma patients are likely to respond to anti-angiogenesis drugs even before therapy is initiated, potentially eliminating treatment destined to be ineffective. A postdoctoral research fellow at the Martinos Center at the time of the study, Emblem is now a principal investigator at Oslo University Hospital in Norway and maintains an affiliation with the Martinos Center.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Additional co-authors of the Nature Medicine paper are Kim Mouridsen, PhD, Christian Farrar, PhD, Dominique Jennings, Ronald Borra, PhD, and Bruce Rosen, MD, PhD, Martinos Center at MGH; Rakesh Jain, PhD, Steele Laboratory of Tumor Biology, MGH Radiation Oncology; Atle Bjornerud, PhD, University of Oslo, Norway; Patrick Wen, MD, Dana-Farber Cancer Institute; and Percy Ivy, MD, National Cancer Institute. Support for the study includes numerous grants from the U.S. Public Health Service, the National Cancer Institute and other funders.

Vessel architectural imaging identifies cancer patient responders to anti-angiogenic therapy

Kyrre E Emblem, Kim Mouridsen, Atle Bjornerud, Christian T Farrar, Dominique Jennings, Ronald J H Borra, Patrick Y Wen, Percy Ivy, Tracy T Batchelor, Bruce R Rosen, Rakesh K Jain & A Gregory Sorensen; Nature Medicine (2013) doi:10.1038/nm.3289

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Hypnotic relaxation therapy improves sexual health for postmenopausal women with hot flashes

Main Category: Menopause
Also Included In: Psychology / Psychiatry;  Sexual Health / STDs
Article Date: 19 Aug 2013 - 1:00 PDT Current ratings for:
Hypnotic relaxation therapy improves sexual health for postmenopausal women with hot flashes

Hypnotic relaxation therapy improves sexual health in postmenopausal women who have moderate to severe hot flashes, according to Baylor University researchers who presented their findings at the American Psychological Association's recent annual meeting.

The study, which examined sexual comfort, sexual satisfaction and sexual pleasure, is a first step toward a safe and effective alternative toward hormone replacement therapy, which carries associated risks of cancer and heart disease, said Gary Elkins, Ph.D., director of Baylor's Mind-Body Medicine Research Laboratory and a professor of psychology and neuroscience in Baylor's College of Arts & Sciences.

The conclusion was based on a study funded by the National Institutes of Health. For the study, 187 women were randomly assigned to receive either five weekly sessions of hypnotic relaxation therapy or supportive counseling, said lead researcher Aimee Johnson, a doctoral student in psychology and neuroscience at Baylor University.

Led by researchers at Baylor's Mind-Body Medicine Research Laboratory, all study sessions were conducted by master's-level therapists trained in clinical hypnosis. Participants in the hypnotic relaxation therapy group received a hypnotic induction followed by suggestions for relaxation, coolness and mental imagery. Participants who received sessions of supportive counseling discussed their symptoms with a trained therapist but did not receive any hypnosis.

Women completed questionnaires at the beginning of the study, at the end of treatment and at a 12-week follow-up. They also were asked to complete a self-report questionnaire assessing the extent to which hot flashes interfered with sexual intimacy. The decrease in estrogen that accompanies menopause is associated with hot flashes, night sweats, weight gain and vaginal dryness, discomfort or pain.

"The most common complaints are being too tired, anxiety, depression, hot flashes and the fear of close contact," Elkins said. Because warmth that comes from closeness can trigger a hot flash, some women grow to fear intimacy, he said.

At treatment's end, women who had received hypnotic relaxation therapy reported significantly higher sexual satisfaction and pleasure, as well as less discomfort. This improvement also was seen at the 12-week follow-up assessment.

"Women's sexual health improved, whether because of sleeping better, less stress or fewer hot flashes, or perhaps other unknown mechanisms," Elkins said.

Researchers noted that postmenopausal sexual health can be affected by factors other than hot flashes, among them fatigue, self-esteem, a partner's health, relationship quality and a lack of interest by either or both partners.

For many women -- among them those who have had breast cancer -- hormone replacement therapy is not an option for menopause-related symptoms. Estrogen, for example, has been associated with more rapid growth of breast cancer.

Previous research by Elkins has shown that clinical hypnosis can effectively reduce hot flashes and associated symptoms among postmenopausal women, including a lessening of anxiety and depression.

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Preventive Isoniazid therapy should be considered for millions of HIV-infected people globally

Main Category: HIV / AIDS
Also Included In: Tuberculosis;  Preventive Medicine
Article Date: 19 Aug 2013 - 0:00 PDT Current ratings for:
Preventive Isoniazid therapy should be considered for millions of HIV-infected people globally

As part of the largest international research effort ever made to combat tuberculosis, a team of Johns Hopkins and Brazilian experts has found that preventive antibiotic therapy for people with HIV lowers this group's chances of developing TB or dying. Specifically, they found in men and women already infected with HIV that taking isoniazid reduced deaths and new cases of active TB disease by 31 percent, while new cases of TB alone decline by 13 percent.

The research team's findings, published in the journal Lancet Infectious Diseases online, stem from what is believed to be the largest expansion of a clinic-based, community health program designed to curb the spread of TB, and the first evidence that such a community-wide effort can be highly effective at preventing people who are co-infected from developing active TB disease.

According to senior study investigator and Johns Hopkins infectious disease specialists Richard Chaisson, M.D., his team's latest study results firmly support broad use of preventive isoniazid therapy for millions of people infected with HIV in Latin American, Asian, and Eastern European countries heavily burdened by TB.

Chaisson says TB disease remains the leading cause of death worldwide among those with HIV/AIDS and is epidemic in developing countries with the highest HIV-infection rates. Isoniazid treatment, which costs less than $1 for a full course of therapy, is already recommended by the World Health Organization to prevent TB in people with HIV disease. The policy, however, has not been widely adopted and its broad impact on the HIV-infected community never shown until the Johns Hopkins and Brazilian team's latest study.

All of the 12,816 study participants were eligible for screening for TB infection or active TB disease. Some 1,186 tested positive for TB infection, but did not have symptoms of TB sickness and could start taking 300 milligrams of isoniazid daily for six months. All received routine follow-up care for as little as a few weeks to as long as four years after initially seeking treatment at any of 29 HIV clinics across Brazil, a country hit hard by both infectious diseases. Some 838 deaths occurred during the study, which took four years to complete, and 475 developed TB. Symptoms of active TB disease, indicating the disease has progressed from latent infection, include persistent cough, chest pain, chills, fever, muscle weakness and fatigue.

"Our study results show that routine testing for TB and preventive isoniazid therapy works well at the community level in people with HIV disease in curbing the spread of TB and lowering the number who die," says Chaisson, a professor at the Johns Hopkins University School of Medicine and founding director of its Center for Tuberculosis Research.

"People with HIV disease living in all countries with rampant TB should be asking their physicians if they are good candidates for preventive isoniazid therapy," says Chaisson, who leads the overall global research effort, in support of this study and others, called the Consortium to Respond Effectively to the AIDS/TB Epidemic. CREATE, as it is known, is funded by the Bill and Melinda Gates Foundation.

When researchers restricted their analysis to 12,196 study participants who kept at least one annual check-up appointment, the overall death rate and number of new TB cases was even lower, at 55 percent. The number of active TB cases decreased by 58 percent. Among study participants who received isoniazid, commonly marketed under the brand names Niazid, Laniazid and Nydrazid, 85 percent took a full course of drugs for six months, as prescribed.

Another important finding, researchers say, was that initial TB screening of those seeking HIV care led to diagnosis of over a third (34 percent, or 250) of the total 725 new clinic patients found to have active TB. All were offered treatment for their disease but were excluded from the study analysis.

Lead study investigator and Johns Hopkins epidemiologist Jonathan Golub, Ph.D., M.P.H., says the study was, on its own, an effective screening tool, and affirms how unknown TB cases can be found when public health officials focus on community health programs in local clinics that service people more likely to become infected. In Brazil, an estimated 10 percent of people diagnosed with TB sickness are co-infected with HIV.

Golub says further research is needed to determine how long lasting are isoniazid's protective effects are and whether the single course of treatment used in the latest study is sufficient, or if repeat or lifelong antibiotic therapy is needed to suppress TB.

"Our efforts highlight the importance of continuous training in diagnosing TB, and our immediate priority is to train community doctors and nurses in HIV clinics to make TB testing part of routine HIV care," says Golub, an associate professor at Johns Hopkins. Golub points out that in Brazil, TB screening policies have been in place since 1995, but simply not followed. Golub says that once clinics involved in the study began more rigorous screening, the number of initial TB skin tests performed jumped threefold, and the number of patients taking isoniazid went up fourfold.

For the study, clinic staff were rigorously trained in correct procedures for screening all patients with HIV for possible TB infection and signs of active TB disease. Patients who tested positive for active TB disease were offered treatment, but were not included in study monitoring. Those who met study criteria were offered preventive isoniazid therapy. To detect TB, a simple skin test is initially performed, which if positive for signs of an immune response, can lead to further, confirmatory lab and X-ray testing.

Intensive training at all 29 clinics was randomly staggered every two months, allowing staff at all clinics to eventually benefit from the enhanced study effort. The staggered timeline also gave researchers a long period to assess isoniazid's effects pre- and post-training. Study participants were 61 percent male, and on average 37 years old. Sixty percent were receiving antiretroviral therapy for HIV.

Chaisson says the team next plans to evaluate faster diagnostic tests for TB, other than the initial skin test, which takes only minutes to administer, but requires a 48-hour waiting period to show any reaction. He says the ideal test would be a blood test that could be performed at the same time as routine anti-HIV tests for blood levels of CD4 immune cells.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Effect of improved tuberculosis screening and isoniazid preventive therapy on incidence of tuberculosis and death in patients with HIV in clinics in Rio de Janeiro, Brazil: a stepped wedge, cluster-randomised trial, doi:10.1016/S1473-3099(13)70187-7

In addition to the Bill and Melinda Gates Foundation, funding support for this study came from the National Institutes of Health Fogarty International Center and the National Institutes of Health. Corresponding grant numbers are U2RTW006885, AI066994 and AI001637.

Besides Chaisson and Golub, other Johns Hopkins researchers involved in this study were Lawrence Moulton, Ph.D.; Bonnie King, M.P.H.; Silvia Cohn, M.S.; and Anne Efron, M.S.N. Additional research assistance was provided by Betina Durovni, M.D.; Valeria Saraceni, M.D.; and Solange Cavalcante, M.D., at Municipal Health Secretariat in Rio de Janeiro, Brazil, and the Federal University of Rio de Janeiro; and Antonio Pacheco, Ph.D., at the Scientific Computing Program, Oswaldo Cruz Foundation, also in Rio de Janeiro.

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Subset of type 1 diabetes patients with strong response to therapy identified

Main Category: Diabetes
Article Date: 19 Aug 2013 - 1:00 PDT Current ratings for:
Subset of type 1 diabetes patients with strong response to therapy identified

Primary results from a new clinical trial show that patients with type 1 diabetes treated with the monoclonal antibody teplizumab (MacroGenics, Inc.) exhibit greater preservation of C-peptide, a biomarker of islet cell function, compared to controls. Further analyses identified a discrete subset of the treatment group that demonstrated especially robust responses ("responders"), suggesting that these patients could be identified prior to treatment. The trial, entitled "Autoimmunity-Blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes" (AbATE), was conducted by the Immune Tolerance Network (ITN). The results are available online and will be published in the November issue of the journal Diabetes.

The AbATE study, led by Kevan Herold, MD (Yale University), tested teplizumab, which targets the CD3 receptor found on T cells, in patients with new-onset type 1 diabetes. CD3 is required for T-cell activation, which can lead to the destruction of insulin-producing beta cells. A previous ITN study with teplizumab showed that a single course of the drug slowed C-peptide decline in new-onset patients for a year, after which the effects waned. The aim of the AbATE study was to test whether C-peptide preservation could be prolonged by administering two courses of teplizumab, one year apart.

In this open-label, Phase II study, 77 new-onset patients (ages 8 to 30 years old) were randomized to receive either teplizumab or a control. Those in the treatment arm received the scheduled treatment consisting of two 14-day courses of teplizumab, one year apart. Both arms received intensive diabetes care from certified diabetes educators and were followed for two years. The primary endpoint compared C-peptide preservation between the two groups.

After two years, the teplizumab-treated group showed significantly greater preservation of C-peptide (75-percent higher responses compared to the control group).

Further analysis revealed that within the treatment arm two groups of patients could be distinguished based on their C-peptide levels: one group, considered "responders" (22/49), showed very little C-peptide decline over the course of the study (only a 6 percent reduction from baseline), while the "non-responders" (27/49) exhibited a similar rate of C-peptide decline as the control group (less than 40-percent reduction from baseline).

Investigators measured various biomarkers and cell types that might distinguish between these two groups. They found that, at trial entry, "responders" had lower hemoglobin A1c levels (a marker of glucose concentration in the blood) and used less insulin at baseline, compared to "non-responders". Differences in specific T-cell subsets also distinguished between the two groups at baseline, suggesting that immune status might contribute to drug responsiveness. However, further studies will be required to confirm these results.

"This overall approach to identifying characteristics of individuals most likely to respond to therapies shows great promise because the responders in this study experienced a robust and prolonged drug effect," said Dr. Herold. "This type of response has not been seen in other studies of immune therapies."

Type 1 diabetes is a disease marked by immune destruction of insulin-producing beta cells in the pancreas. New-onset patients usually have 20 to 40 percent of their normal beta cell mass remaining, which is still capable of producing insulin. Preserving this remaining mass, even temporarily, could improve long-term clinical outcomes.

Immune modulators, like teplizumab, represent a promising means of inducing tolerance; however, no drug has been shown to prevent or reverse disease, and only a few have temporarily delayed disease progression. The ability to identify a subgroup of patients who may be more responsive to therapy could greatly enhance the clinical use of immune modulators and improve outcomes for those patients. Further analyses with specimens collected from the AbATE study are ongoing to understand the mechanism of response.

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Researchers have developed an experimental therapy that can kill human blood cancer cells in the laboratory and eradicate the disease in mice

Main Category: Lymphoma / Leukemia / Myeloma
Article Date: 15 Aug 2013 - 0:00 PDT Current ratings for:
Researchers have developed an experimental therapy that can kill human blood cancer cells in the laboratory and eradicate the disease in mice

Ottawa researchers have developed unique virus-derived particles that can kill human blood cancer cells in the laboratory and eradicate the disease in mice with few side effects. The study is published in Blood Cancer Journal by co-senior authors Drs. David Conrad and John Bell of the Ottawa Hospital Research Institute (OHRI) and the University of Ottawa (uOttawa).

While Dr. Bell and his colleagues have been investigating replicating viruses for the treatment of solid cancers for many years, with very promising results, this is the first major success they have had treating blood cancer (leukemia). It is also the first success they have had using a non-replicating virus-derived particle as opposed to a replicating virus.

"Our research indicated that a replicating virus might not be the safest or most effective approach for treating leukemia, so we decided to investigate whether we could make virus-derived particles that no longer replicate but still kill cancer," said Dr. Conrad, a hematologist conducting research in the Blood and Marrow Transplant Program at The Ottawa Hospital, and currently completing his PhD at OHRI and uOttawa in the Department of Cellular and Molecular Medicine. "We were delighted to see that this novel therapy was very safe at high doses, and worked extremely well in our laboratory leukemia models. We hope to test this in patients in the near future."

The researchers used a specific method and dose of UV light to transform regular replicating viruses into unique particles that could no longer replicate and spread, but could still enter cancer cells efficiently, kill them and stimulate a strong immune response against the cancer. These particles were able to kill multiple forms of leukemia in the laboratory, including samples taken from local patients who had failed all other therapies. Normal blood cells were not affected. This novel treatment was also successful in mouse models of leukemia. In fact, 80 per cent of the mice that received the therapy had markedly prolonged survival and 60 per cent were eventually cured, while all of the untreated mice died of their leukemia within 20 days.

"Leukemia is a devastating disease that can be very difficult to treat, and new therapies are urgently needed," said Dr. Conrad. "While we're still at the early stages of this research, I think this therapy holds a lot of promise because it appears to have a potent, long-lasting effect on leukemia without the debilitating side effects of many cancer therapies used in the clinic right now. We will likely see even better results once we optimize the dose in our preparations to advance this research into human clinical trials."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our lymphoma / leukemia / myeloma section for the latest news on this subject.

This research was funded by the Ontario Institute for Cancer Research, the Terry Fox Foundation, the Natural Sciences and Engineering Research Council of Canada, the Canadian Institutes of Health Research, Ottawa's Department of Medicine and The Ottawa Hospital Foundation.

Non-replicating rhabdovirus-derived particles (NRRPs) eradicate acute leukemia by direct cytolysis and induction of antitumor immunity. Batenchuk C, Le Boeuf F, Stubbert L, Falls T, Atkins HL, Bell JC, and Conrad DP. Blood Cancer J. 2013 Jul 12;3:e123. doi: 10.1038/bcj.2013.23.

Ottawa Hospital Research Institute

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CDK6 represents a promising target for anti-cancer therapy

Main Category: Cancer / Oncology
Also Included In: Genetics
Article Date: 15 Aug 2013 - 0:00 PDT Current ratings for:
CDK6 represents a promising target for anti-cancer therapy

Cell division is tightly controlled by a number of genes and because of the importance of ensuring that the process stays in check - mistakes frequently lead to cancer - mammalian cells often have several inbuilt layers of security. The two cyclin-dependent kinases CDK4 and CDK6 are widely believed to have almost identical functions, so either one of them can compensate for problems with the other. New work at the University of Veterinary Medicine, Vienna challenges this view and shows that, unlike CDK4, CDK6 also promotes the growth of blood vessels. This explains why CDK6 is so frequently misregulated in certain types of cancer. The results are published in the current issue of the prestigious international journal Cancer Cell.

Cancer in humans is frequently associated with unusually high amounts of one or more proteins responsible for controlling the rate at which cells divide. As an example, excessive amounts of the cyclin-dependent kinase CDK6 are often found in types of cancer such as lymphoma. Together with a number of collaborators within Vienna and beyond, Karoline Kollmann of the University of Veterinary Medicine, Vienna (Vetmeduni) has now shown that CDK6 is part of a multiprotein complex that stimulates the production of one of the so-called INK4 family members (confusingly termed p16INK4a), which suppresses tumour growth. In other words, the cell has an inbuilt mechanism to help it cope with excessive amounts of CDK6.

The problems really start when p16INK4a is missing, as is frequently the case in lymphomas or leukaemias. Now the high levels of CDK6 are unchecked and so can lead directly to a stimulation of cell division. Furthermore, Kollmann and her colleagues showed that another CDK6-containing complex can also promote the production of an additional factor, known as VEGF-A, that increases the growth of blood vessels and thus ensures that the cells in the growing tumours are supplied with sufficient energy and oxygen to multiply. CDK6 is the first factor to be shown to be involved in regulating tumour growth while simultaneously helping to supply tumours with blood.

As its name implies, CDK6 is a kinase, i.e. it adds phosphate groups to other proteins and thereby alters their activity. In a further twist to the tale, the Vetmeduni scientists have shown that CDK6 can still exert its effects on p16INK4a and VEGF-A when it lacks its kinase activity: a mutant form of the CDK6 protein with the kinase function inactivated retains the ability to regulate expression of the p16INK4a and VEGF-A genes.

Veronika Sexl, Head of the Vetmeduni's Institute of Pharmacology and Toxicology, where the work was performed, notes the medical importance of her group's findings. "Because it is known to be involved in so many cancers, CDK6 represents a promising target for anti-cancer therapy and lots of labs are trying to design specific inhibitors. But their efforts are focused on inhibiting CDK6's kinase function. We have shown that CDK6 has an additional, kinase-independent mode of action that is responsible for the uncontrolled cell growth and increased production of blood vessels that are a hallmark of cancer. CDK6 inhibitors will also need to block this new function if they are to be effective in treating cancer."

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The paper - A new kinase-independent function of CDK6 links the cell cycle to tumor angiogenesis by Karoline Kollmann, Gerwin Heller, Christine Schneckenleithner, Wolfgang Warsch, Ruth Scheicher, Rene G. Ott, Markus Schäfer, Sabine Fajmann, Michaela Schlederer, Ana-Iris Schiefer, Ursula Reichart, Matthias Mayerhofer, Christoph Hoeller, Sabine Zoechbauer-Mueller, Dontscho Kerjaschki, Christoph Bock, Lukas Kenner, Gerald Hoefler, Michael Freissmuth, Anthony R. Green, Richard Moriggl, Meinrad Busslinger, Marcos Malumbres and Veronika Sexl; Cancer Cell, Volume 24, Issue 2, 167-181, 12 August 2013; 10.1016/j.ccr.2013.07.012

University of Veterinary Medicine -- Vienna

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Children with high-risk neuroblastoma benefit from new, precise proton therapy cancer treatment

Main Category: Cancer / Oncology
Also Included In: Neurology / Neuroscience;  Pediatrics / Children's Health
Article Date: 15 Aug 2013 - 1:00 PDT Current ratings for:
Children with high-risk neuroblastoma benefit from new, precise proton therapy cancer treatment

Proton therapy, using high-energy subatomic particles, may offer a precise, organ-sparing treatment option for children with high-risk forms of neuroblastoma. For patients in a new study of advanced radiation treatment, proton therapy spared the liver and kidneys from unwanted radiation, while zeroing in on its target.

"As survival rates improve for children with neuroblastoma, we need to reduce treatment-related long-term toxicities," said study leader Christine Hill-Kayser, MD, a radiation oncologist in The Children's Hospital of Philadelphia's (CHOP) Cancer Center. "Proton beam therapy offers precise targeting with less radiation exposure to healthy tissue."

Hill-Kayser and colleagues published their study online recently in Pediatric Blood & Cancer.

Owing to collaboration between Children's Hospital and radiation oncologists at Penn Medicine, the Roberts Proton Therapy Center, where the study was conducted, is the first proton therapy facility in the U.S. conceived with pediatric patients in mind from the earliest planning stages.

Proton therapy for high-risk neuroblastoma

Protons, the positively charged particles in an atom's nucleus, are used in therapy to destroy DNA in tumors and prevent cancer cells from multiplying. In children, this therapy is often used against spinal tumors. CHOP has recently been directing protons at neuroblastoma, long a special focus of the Hospital's clinical and research programs.

Neuroblastoma, the most common solid tumor of early childhood, strikes the peripheral nervous system, usually appearing as a solid tumor in a young child's chest or abdomen.

Pediatric oncologists have an arsenal of weapons against neuroblastoma, but high-risk forms of this cancer present a particular challenge, often frustrating conventional treatment from the start or recurring in a resistant form.

The current study, said Hill-Kayser, included 13 children with a median age of 3 years who responded well to initial chemotherapy, followed by surgery, more chemotherapy, bone marrow transplant, and in some cases, immunotherapy. The advanced radiation treatment aimed to destroy remaining microscopic areas of cancer cells while minimizing toxicity to healthy tissue. Importance of tailoring treatment for each child

In planning radiation treatment for each child, the study team determined that 11 patients should receive proton therapy, and that two other patients, because of their specific anatomy and the location of their tumors, should receive intensity-modulated X-ray therapy (IMXT). In IMXT, radiologists sculpt the radiation emitted from 7 different angles to modify radiation dosages in and around the targeted area.

None of the 13 patients had local disease recurrence or acute organ toxicity. For 11 of them, proton therapy provided the best combination of target coverage and organ sparing. "Protons are heavier than the particles in X-rays and have more stopping power," said Hill-Kayser. "They deposit 90 percent of their energy precisely at the tumor site, with nearly zero radiation away from the tumor. That protects healthy organs - which, as growing tissues, are especially vulnerable to radiation damage in young children."

The fact that individual characteristics made IMXT preferable to proton therapy in two children, said Hill-Kayser, underscores the need to meticulously customize radiation treatment to each patient. Overall, the current study shows that proton therapy should be considered for children with high-risk neuroblastoma. She added, "To better assess the use of proton therapy against high-risk neuroblastoma, we'll need to study larger numbers of patients and do long-term follow-up. However, this represents a great start."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Co-authors of this study were Robert Lustig, MD, Zelig Tochner, MD, and Stefan Both, PhD; like Hill-Kayser, all are from the Department of Radiation Oncology of the Perelman School of Medicine at the University of Pennsylvania. Co-authors Anne Reilly, MD, Naomi Balamuth, MD, Richard Womer, MD, John Maris, MD, Stephan Grupp, MD, PhD, and Rochelle Bagatell, MD, are from the Cancer Center for Children at CHOP.

Hill-Kayser et al, “Proton versus photon radiation therapy for patients with high-risk neuroblastoma: The need for a customized approach,” Pediatric Blood & Cancer, published online, June 4, 2013. DOI: 10.1002/pbc.24606

Children's Hospital of Philadelphia

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Possible new avenues for gene therapy via enhancer RNAs

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Postdoctoral Researcher Minna U. Kaikkonen at A.I. Virtanen Institute for Molecular Sciences at the University of Eastern Finland was one of the two lead authors of the current study, carried out under Professor Christopher Glass. Dr Kaikkonen completed her post doc study in Professor Glass' research group at the University of California, San Diego in 2009. Besides Dr Kaikkonen, the UEF contributors to the earlier study from June also include Postdoctoral Researcher Hanna P. Lesch.

The main funders of the study are Fondation Leducq, Sigrid Jusélius Foundation, the Academy of Finland, ASLA Fulbright, the Finnish Foundation for Cardiovascular Research, the Finnish Cultural Foundation (North Savo Regional Fund), Orion-Farmos Research Foundation and the US National Institutes of Health grants DK091183, CA17390, and DK063491.

Research article in Molecular Cell:

Remodeling of the Enhancer Landscape during Macrophage Activation Is Coupled to Enhancer Transcription

Kaikkonen MU, Spann N, Heinz S, Romanoski CE, Allison KA, Stender JD, Chun HB, Tough DF, Prinjha RK, Benner C and Glass CK. Remodeling of the enhancer landscape during macrophage activation is linked to enhancer transcription. Molecular cell, 2013; Volume 51, Issue 3, 310-325;10.1016/j.molcel.2013.07.010

Research article in Nature:

Rev-Erbs repress macrophage gene expression by inhibiting enhancer-directed transcription

Lam MTY, Cho H, Lesch HP, Heinz S, Tanaka-Oishi Y, Benner C, Kaikkonen MU, Salim A, Kosaka M, Lee CY, Watt A, Grossman T, Rosenfeld MG, Evans RM, Glass CK. Rev-Erbs negatively regulate macrophage gene expression by repressing enhancer-directed transcription. Nature 2013 Jun 27; 498(7455):511-5; doi:10.1038/nature12209

University of Eastern Finland

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Rituximab therapy effective for ANCA-associated vasculitis

Main Category: Vascular
Also Included In: Immune System / Vaccines
Article Date: 04 Aug 2013 - 0:00 PDT Current ratings for:
Rituximab therapy effective for ANCA-associated vasculitis

In an article published in the New England Journal of Medicine, Immune Tolerance Network (ITN) researchers demonstrated that a single course of rituximab therapy (anti-CD20; Rituxan, Genentech, Inc.) is as effective as the current standard of care regimen of drugs for remission induction and maintenance in patients with ANCA-associated Vasculitis (AAV). AAV is an autoimmune disease marked by the presence of antibodies that attack neutrophils and cause inflammation of the blood vessels, leading to organ damage and sometimes death. The standard of care for this disease was cyclophosphamide, a potent immunosuppressant that although effective is very toxic when used long-term. Rituximab has a shorter and simpler treatment course compared to standard therapy, thus offering significant treatment advancement for patients with AAV.

The RAVE study is a 197-patient randomized, double-blind, placebo-controlled trial comparing rituximab against cyclophosphamide for remission induction in patients with severe AAV. This clinical trial is led by John Stone, MD (Massachusetts General Hospital) and Ulrich Specks, MD (Mayo Clinic), and is sponsored by the ITN, a clinical trial network funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The FDA approved a label extension for rituximab for use in AAV after the initial 6-month results of the RAVE study demonstrated that rituximab in combination with glucocorticoids was non-inferior to cyclophosphamide in combination with glucocorticoids for inducing complete remission in patients with severe AAV (reported in the New England Journal of Medicine in 2010; doi: 10.1056/NEJMoa0909905). This represented the first approved therapy for AAV in over 40 years.

This publication reports safety and relapse rates among the two treatment groups out to month 18. Patients in the rituximab arm received only one, short course of therapy over 4 weeks, and those in remission received only placebo therapy through month 18. Alternately, patients in the standard therapy arm received 3-6 months of cyclophosphamide followed by azathioprine through the length of the study. Patients who achieved remission had glucocorticoids discontinued before month 6 and did not take any glucocorticoids through month 18 if they remained in remission.

At 18 months, 39% of patients in the rituximab arm were relapse-free (n=39), compared to 33% in the standard therapy arm (n=32). There were no significant differences in overall adverse events between the two groups, although there were fewer cases of pneumonia and leukopenia in the rituximab arm. These results suggest that a short course of rituximab (four once weekly infusion) is as effective for the induction and maintenance of remission in severe AAV patients as continuous treatment over 18 months with standard immunosuppressive drugs that require ongoing monitoring for toxicities.

"The RAVE study is remarkable for several reasons", said Ulrich Specks. "First, its results have provided patients who suffer from these chronically relapsing diseases with access to a very effective alternative to cyclophosphamide to induce remission. Second, the study has shown that a short course of 4 infusions of rituximab is as effective as 18 months of ongoing daily oral therapy with immunosuppressive drugs that require frequent blood test monitoring to assure their safe use. Third, the RAVE study is a model for successful partnerships of federal funding agencies, federally funded research organizations and industry for the study of rare diseases. Last not least, today's publication illustrates how complete transparency between published study analyses and all raw study data can be provided to the public".

Data sets and statistical analyses from the RAVE study are available to the public through ITN TrialShare, a new clinical trials research portal. This publication is the first to provide public access to the raw study data via direct links from the publication and its figures to the data sets in ITN TrialShare. This represents a big step forward in the general quest for complete transparency of all data accumulated during the conduct of clinical trials.

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About The Immune Tolerance Network

The Immune Tolerance Network (ITN) is a research consortium sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The ITN develops and conducts clinical and mechanistic studies of immune tolerance therapies designed to prevent disease-causing immune responses, without compromising the natural protective properties of the immune system. Visit http://www.immunetolerance.org/ for more information.

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Targeted therapy identified for protein that protects and nourishes cancer - inhibitor found that blocks Skp2

Main Category: Cancer / Oncology
Article Date: 05 Aug 2013 - 1:00 PDT Current ratings for:
Targeted therapy identified for protein that protects and nourishes cancer - inhibitor found that blocks Skp2

Scientists at The University of Texas MD Anderson who identified a protein's dual role in cancer promotion have discovered a way to shut it down, opening a potential new avenue for cancer treatment.

Reporting this week in the journal Cell, the researchers describe the first compound that directly binds to and blocks Skp2, a protein they previously showed both turns off a cellular defense against cancer and switches on a cancer-feeding metabolic pathway.

"The beauty of this study is we identified an inhibitor and showed how it functions to block Skp2. Inhibitors often are discovered without an initial understanding of how they work," said co-senior author Hui-Kuan Lin, Ph.D., associate professor of Cellular and Molecular Oncology at MD Anderson.

Lin teamed with co-senior author Shuxing Zhang, Ph.D., assistant professor of Experimental Therapeutics and head of the Integrated Molecular Discovery Laboratory at MD Anderson, to identify and characterize the drug.

"There are many more chemical compounds available than there are estimated stars in the universe," Zhang said. "We have a database with 10 million compounds, but our prescreening analysis narrowed our computerized search to 120,000 and then further to find small-molecule candidates that inhibit Skp2."

Their inhibitor plugs critical binding sites on Skp2, preventing it from connecting to Skp1 to form a complex, which is the first step in its two cancer-promoting functions, Lin said.

Compound hits prostate, lung tumors

"This compound has a high degree of specificity ?" our tests in prostate and lung cancer show it preferentially targets the cancer cells but not the normal cells," Lin said. Steps remain to define the drug's potential off-target effects before it can advance to human clinical trials, Lin said.

The researchers also found that the inhibitor suppresses prostate cancer stem cells, which play a role in cancer initiation, progression and resistance to chemotherapy.

Normally, Skp2 E3 ligase binds to and tags other proteins with molecules called ubiquitins, which can serve as activation signals or as targets marking the protein for destruction. Skp2 is overexpressed in numerous cancers and plays a critical role in cell cycle progression leading to cell division, metabolism and dormancy, as well as cancer progression and metastasis.

Lin and colleagues previously showed that Skp2 promotes cancer by:

Marking for destruction a cancer-stifling protein called p27 that renders cells senescent, or incapable of dividing. Firing up a signaling pathway that activates glucose metabolism (glycolysis), which cancer cells primarily rely upon to grow and survive. They also showed that the glycolysis pathway contributes to Herceptin resistance and shorter survival among breast cancer patients whose tumors heavily express the HER2 protein.

By analyzing the connection between Skp2 and Skp1, Zhang's group identified two pocket-like regions on Skp2 where the proteins connect.

Skp2 has been a logical target for cancer therapy, Zhang said, but presented two major obstacles.

Targeting protein-protein interactions is already difficult and Skp2 has a huge area where it interfaces with other proteins, making it hard to find one small molecule to completely block that surface.

"To begin such a search, to rationally design a drug, you must first understand the target's biology and then look at its structure and fully comprehend its complex interactions and how disrupting those will help treat the disease," Zhang said. "Once you understand those, you're ready to screen using computer models."

Virtual screening of the 120,000 compounds with a program developed by Zhang revealed 25 candidates that bind to either or both pockets. Additional analyses showed that Compound #25, also known as SZL-P1-41, effectively disrupted Skp1-Skp2 interactions.

Subsequent experiments showed Compound #25 suppresses Skp2-related tagging and destruction of the cell dormancy protein p27, restoring its expression in prostate cancer cells, and also stifles Skp2 signaling that activates the cancer-feeding glycolysis pathway.

Detailed experiments showed the drug's effect is achieved by binding specifically to one of the pockets on Skp2 to disrupt formation of the Skp2-Skp1 complex.

Initial cell line experiments showed Compound #25 selectively destroyed prostate cancer cells with minimal effects on normal tissue. The drug's effects were confirmed in two lung cancer cell lines and in liver and osteocarcinoma cell lines.

Underlying mechanisms for the drug's effect on prostate cancer cells proved to be cellular senescence initiation and glycolysis suppression.

Recent research indicates that glycolysis is important to cancer stem cell formation and that senescence through telomere shortening restrains cancer stem cell growth.

Since Compound #25 blocks glycolysis and promotes senescence, the team tested its effect on prostate cancer stem cells.

Treatment stymies cancer stem cell formation, shrinks tumors

Treating prostate cancer cells with the compound reduced the population of cancer stem cells in a dose-dependent manner. The drug didn't work at all in cancer cells where Skp2 had been silenced.

Because cancer stem cells are a major cause of chemotherapy resistance, the researchers treated cell lines with Compound #25 and either of the chemotherapies doxorubicin or cyclophosphamide. Combining the new drug tripled the cancer cell growth inhibition of doxorubicin and doubled that of cyclophosphamide.

Finally, evasion of cellular senescence and promotion of glycolysis are hallmarks of cancer progression and drug resistance. The team tested its drug in mice with prostate and lung tumors. In both cases, treated mice had tumors about a quarter of the size of those in mice injected with a control agent.

Lin, Zhang and MD Anderson have filed for patent protection of this work.

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Visit our cancer / oncology section for the latest news on this subject.

Co-authors and funding

Co-authors include first author Chia-Hsin Chan, Ph.D., Yuan Gao, Guoxiang Jin, Ph.D., Asad Moten, Zhen Cai, Ph.D., Dazhi Xu, Ph.D., and Mien-Chie Hung, Ph.D., of MD Anderson's Department of Molecular and Cellular Oncology; John Kenneth Morrow of Experimental Therapeutics; Loren Stagg, Ph.D., and John Ladbury, Ph.D., of Biochemistry and Molecular Biology; Christopher Logothetis, M.D., of Genitourinary Medical Oncology; and Chien-Feng Li, M.D., Ph.D., Chi-Mei Foundational Medical Center and the National Institute of Cancer Research, Taiwan.

Gao and Morrow are students in The University of Texas Graduate School of Biomedical Sciences at Houston, a joint program of MD Anderson and The University of Texas Health Science Center at Houston.

This research was funded by the MD Anderson Trust Scholar Award, MD Anderson's Prostate SPORE grant from the National Cancer Institute of the National Institutes of Health (P50 CA140388) and its NCI Cancer Center Support Grant (CA 016672), a grant from the American Cancer Society, an MD Anderson Center for Targeted Therapy-University of Texas at Austin Texas Institute for Drug and Diagnostics Development joint grant; and also a career development award from MD Anderson's NCI Breast Cancer SPORE and a Susan G Komen Foundation Postdoctoral Fellowship Award to Chan.

University of Texas M. D. Anderson Cancer Center

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Virginia Tech researcher uses micro-fabricated blood vessels to study tumor growth and anti-angiogenic cancer therapy

Main Category: Cancer / Oncology
Also Included In: Blood / Hematology
Article Date: 02 Aug 2013 - 1:00 PDT Current ratings for:
Virginia Tech researcher uses micro-fabricated blood vessels to study tumor growth and anti-angiogenic cancer therapy

Researchers have established a 3-D microfluidic system to study a biological process known as endothelial sprouting. This process represents an early step in new blood vessel growth called angiogenesis.

Breakthroughs in an integrated understanding of angiogenesis will benefit researchers in broad biomedical fields, including cancer, vascular science, and tissue engineering. The reason for this interest in the cancer field is that tumors must access the host blood supply to obtain nutrients essential for growth. They do this by co-opting nearby blood vessels, causing them to sprout into and vascularize the tumor bulk in angiogenesis. The progression of the tumor results in fatal cancer.

Scott Verbridge, assistant professor in the School of Biomedical Engineering and Sciences at Virginia Tech, along with senior investigators at the Cornell University Physical Sciences-Oncology Center, developed the system using in vitro models, or living engineered tissues, with support from the National Cancer Institute's Physical Sciences in Oncology.

In the scientific community, relatively little is known about the integrated physico-chemical processes involved in angiogenesis. Blood vessel intrinsic processes can augment or inhibit cell sprouting initially driven by chemical signals from the tumor cells, such that drugs designed to block these tumor-derived chemical triggers may not always be effective. However tools to study these important details have been lacking.

"Angiogenesis has been extensively studied in this field and is one of the areas where innovative microenvironment-targeted therapies have actually made it to patients. However these treatments do not work nearly as well as people hoped," said Verbridge. "Developing in vitro models will help us understand the various regulators of angiogenesis, how these may influence the efficacy of current treatments, and motivate new treatment ideas."

The system uses natural tissue materials, consisting of three defined microchannels embedded in type I collagen hydrogels, designed to imitate the structural support into which new blood vessels regenerate. Two parallel side channels provide the means to create biochemical gradients that cross the endothelial cell-coated central channel.

New blood vessel sprouting transpires when gradients of vascular endothelial growth factor (VEGF) are applied across the central channel, however blood vessel geometry and density were also unexpectedly found to strongly regulate sprouting dynamics.

The results are described in a paper published in the Journal of Biomedical Materials Research Part A and highlight the importance of mechanical factors, as well as biochemical ones. Verbridge's laboratory, a multidisciplinary research group collaborating with Virginia Tech labs in biomedical engineering, electrical and computer engineering, and chemical engineering; and the Wake Forest Comprehensive Cancer Center, work to develop innovative paradigms for more effective treatment of currently incurable forms of cancer. Tumor metabolism, experimental tumor evolution, energy-based cancer therapies, and graphene nano-bio interfaces are a few of the projects being pursued by lab investigators.

The College of Engineering at Virginia Tech is internationally recognized for its excellence in 14 engineering disciplines and computer science. The college's 6,000 undergraduates benefit from an innovative curriculum that provides a "hands-on, minds-on" approach to engineering education, complementing classroom instruction with two unique design-and-build facilities and a strong Cooperative Education Program. With more than 50 research centers and numerous laboratories, the college offers its 2,000 graduate students opportunities in advanced fields of study such as biomedical engineering, state-of-the-art microelectronics, and nanotechnology. Virginia Tech, the most comprehensive university in Virginia, is dedicated to quality, innovation, and results to the commonwealth, the nation, and the world.

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"Physicochemical regulation of endothelial sprouting in a 3D microfluidic angiogenesis model", Scott S. Verbridge, Anirikh Chakrabarti, Peter DelNero, Brian Kwee, Jeffrey D. Varner, Abraham D. Stroock, Claudia Fischbach, Article first published online: 5 APR 2013, DOI: 10.1002/jbm.a.34587

Virginia Tech

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Tech, Virginia. "Virginia Tech researcher uses micro-fabricated blood vessels to study tumor growth and anti-angiogenic cancer therapy." Medical News Today. MediLexicon, Intl., 2 Aug. 2013. Web.
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No improvement seen in HIV-associated lymphoma survival during the antiretroviral therapy era

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: HIV / AIDS
Article Date: 30 Jul 2013 - 0:00 PDT Current ratings for:
No improvement seen in HIV-associated lymphoma survival during the antiretroviral therapy era

Stable survival rates were observed for HIV-associated lymphoma patients during the antiretroviral therapy (ART) era in the US, according to a new study published in the Journal of the National Cancer Institute.

Studies have shown that HIV infection increases the risk of non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL) and that incidence for many lymphoma types has not decreased in the ART era. Furthermore, lymphoma is the most frequent cancer-related cause of death among HIV-infected persons. However, trends in presentation and survival have not been investigated among HIV-associated lymphoma patients in routine care since the beginning of the ART era.

Satish Gopal, M.D., M.P.H., from the Program in Global Oncology at the Lineberger Comprehensive Cancer Center of the University of North Carolina, and colleagues compared differences in presentation and survival, across histologic subtypes and diagnosis years, among HIV-infected lymphoma patients. They also examined predictors of death in this population. Data from 476 HIV-associated lymphoma patients living in the US who were diagnosed with various types of lymphoma including HL, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), primary central nervous system lymphoma (PCNSL), and other types of NHL, between 1996 and 2010 were analyzed using various statistical methods.

Their results demonstrate that HIV-associated lymphoma is heterogeneous and changing since the ART era began. Clinical presentations across the different lymphoma subtypes was highly variable during the study period (79 HL, 201 DLBCL, 56 BL, 54 PCNSL, and 86 with other NHL). Histologic shifts in the proportion of BL vs other NHL subtypes is increasing consistent with other reports. Data showed that more recently diagnosed patients were older and more likely to be male, of nonwhite/nonblack ethnicity (primarily Latino patients), to be men who have sex with men, and to have prior AIDS-related illness. They were also more likely to be on ART at lymphoma diagnosis with higher CD4 counts and better HIV control. The authors also report that more recent diagnosis year was not associated with decreased mortality and that 61.6% of patients with HIV-associated HL were alive 5 years after lymphoma diagnosis, compared with 50.0% for BL, 44.1% for DLBCL, 43.3% for other NHL, and 22.8% for PCNSL. Of note, lymphomas occurring on ART were associated with a doubling of mortality, which may suggest important biologic differences between tumors developing on and off ART, although these results require confirmation.

Gopal and colleagues conclude, "These results highlight an ongoing need to elucidate lymphoma biology and optimize treatments for this challenging population to reduce deaths from one of the leading causes of mortality in the modern ART era."

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In an accompanying editorial, Kieron Dunleavy, M.D., and Wyndham H. Wilson, M.D., Ph.D., from the Metabolism Branch of the Center for Cancer Research at the National Cancer Institute, state the findings reflect the shifting demographics of the HIV epidemic in the US. However, the shift towards more biologically favorable and curable types of lymphoma has not resulted in improved survival over the study period. They assert, "In conclusion, because HIV-associated lymphomas are potentially as curable as those arising in HIV-negative patients, it is critical that they be approached with the same care as HIV negative cases."

Journal of the National Cancer Institute

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Seizures reduced and progression of epilepsy slowed by adenosine therapy

Main Category: Epilepsy
Article Date: 29 Jul 2013 - 0:00 PDT Current ratings for:
Seizures reduced and progression of epilepsy slowed by adenosine therapy

Epilepsy is characterized by recurrent seizures that present in many different ways. In some cases epileptic patients exhibit a progressive increase in both frequency and severity of seizures. Epigenetic changes such as DNA methylation have recently been implied as an underlying cause of several neurologic disorders, including epilepsy.

In this issue of the Journal of Clinical Investigation, Detlev Boison and colleagues at Legacy Research show an increase of DNA methylation in the hippocampi of epileptic animals. They found that increased methyation corresponded with a decrease of adenosine (ADO), which is a known anticonvulsant.

The authors used bioengineered implants to transiently deliver ADO to the brains of epileptic rats. Targeted ADO delivery to the brain reversed DNA hypermethylation and resulted in a decrease in seizures and prevented epilepsy progression.

These data indicate that therapies aimed at reducing DNA methylation in the brain have potential for the treatment and prevention of epilepsy.

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TITLE: Epigenetic changes induced by adenosine augmentation therapy prevent epileptogenesis

View this article at: http://www.jci.org/articles/view/65636?key=b830cd2835e7b6acdd11

Journal of Clinical Investigation

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New stem cell gene therapy gives hope to prevent Sanfilippo - an inherited neurological disease

Main Category: Neurology / Neuroscience
Also Included In: Stem Cell Research;  Genetics
Article Date: 25 Jul 2013 - 1:00 PDT Current ratings for:
New stem cell gene therapy gives hope to prevent Sanfilippo - an inherited neurological disease

Scientists from The University of Manchester have used stem cell gene therapy to treat a fatal genetic brain disease in mice for the first time.

The method was used to treat Sanfilippo - a fatal inherited condition which causes progressive dementia in children - but could also benefit several neurological, genetic diseases.

Researchers behind the study, published in the journal Molecular Therapy this month, are now hoping to bring a treatment to trial in patients within two years.

Sanfilippo, a currently untreatable mucopolysaccharide (MPS) disease, affects one in 89,000 children in the United Kingdom, with sufferers usually dying in their mid-twenties. It is caused by the lack of SGSH enzyme in the body which helps to breakdown and recycle long chain sugars, such as heparan sulphate (HS). Children with the condition build up and store excess HS throughout their body from birth which affects their brain and results in progressive dementia and hyperactivity, followed by losing the ability to walk and swallow.

Dr Brian Bigger, from the University of Manchester's Institute of Human Development who led the research, said bone marrow transplants had been used to correct similar HS storage diseases, such as Hurler syndrome, by transplanting normal cells with the missing enzyme but the technique did not work with Sanfilippo disease. This is because monocytes, a type of white blood cell, from the bone marrow, did not produce enough enzyme to correct the levels in the brain.

Dr Bigger said: "To increase SGSH enzyme from bone marrow transplants, and to target it to the cells that traffic into the brain, we have developed a stem cell gene therapy which overproduces the SGSH enzyme specifically in bone marrow white blood cells.

"We have shown that mice treated by this method produce five times the normal SGSH enzyme levels in the bone marrow and 11 per cent more compared to normal levels in the brain.

"The enzyme is taken up by affected brain cells and is enough to correct brain HS storage and neuro inflammation to near normal levels and completely corrects the hyperactive behaviour in mice with Sanfilippo.

"This is extremely exciting and could have huge implications for treatments. We now hope to work to a clinical trial in Manchester in 2015."

The University of Manchester team is now manufacturing a vector - a tool commonly used by molecular biologists to deliver genetic material into cells - for use in humans and hope to use this in a clinical trial with patients at Central Manchester University Hospital NHS Foundation Trust by 2015.

The stem cell gene therapy approach was recently shown by Italian scientists to improve conditions in patients with a similar genetic disease affecting the brain called metachromatic leukodystrophy, with results published in the journal Science earlier this month.

Manchester scientists refined the vector used by the Italian scientists. "This approach has the potential to treat several neurological genetic diseases," Dr Bigger added.

The research was funded by the UK MPS Society and the Sanfilippo Children's Research Foundation based in Canada.

Christine Lavery MBE, Chief Executive of the UK MPS Society, said: "Since 1970 over 130 children and young adults have lost their lives to Sanfilippo disease (MPS III) in the UK alone.

"Whilst new therapies for other MPS diseases are changing children's lives, parents of children with Sanfilippo disease can do no more than give the best possible care and live in hope that a treatment is around the corner. The positive results of Dr Brian Bigger's gene therapy programme in mice provides optimism for future generations of Sanfilippo children."

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The research is published in the journal Molecular Therapy this month.

The University of Manchester

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