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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Mediterranean diet 'reduces genetic stroke risk'

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Academic Journal
Main Category: Stroke
Also Included In: Nutrition / Diet;  Diabetes
Article Date: 15 Aug 2013 - 8:00 PDT Current ratings for:
Mediterranean diet 'reduces genetic stroke risk'

Scientists say they have discovered that the Mediterranean diet may prevent a genetic risk of stroke since it appears to interact with a particular gene variant usually associated with type 2 diabetes.

Researchers from the Jean Mayer USDA Human Nutrition Research center on Aging (USDA HNRCA) at Tufts University, and the CIBER Fisiopatología de la Obesidad y Nutricion in Spain, conducted the study, which was published in the journal Diabetes Care.

The research team analyzed 7,018 men and women involved in the Prevencion con Dieta Mediterranea (PREDIMED) trial. The trial, carried out over a 5-year period, looked at whether a Mediterranean or a low-fat controlled diet had an effect on the risk of cardiovascular disease, stroke and heart attack, and whether genetics played a part in this.

Prior to the trial, participants were also required to complete food frequency questionnaires, in order to see how closely participants followed a Mediterranean diet.

The study focused on a particular variant found in the Transcription Factor 7-like 2 (TCF7L2) gene. The variant is commonly involved in glucose metabolism and can lead to the development of type 2 diabetes. The researchers say this gene variant's link to heart disease has previously been unclear.

Around 14% of the PREDIMED participants were found to be homozygous carriers, meaning they possessed two copies of this gene variant.

Of these homozygous participants who were also following the Mediterranean diet, results of the analysis revealed a reduced number of strokes. José Ordovás, director of the Nutrition and Genomics Laboratory at the USDA HNRCA, explains:

"Being on the Mediterranean diet reduced the number of strokes in people with two copies of the variant.

The food they ate appeared to eliminate any increased stroke susceptibility, putting them on an even playing field with people with one or no copies of the variant."

However, Ordovás adds that homozygous carriers who were following the low-fat diet did not have the same results, with a three times increased risk of having a stroke compared with participants with only one or no copies of the gene variant.

Delores Corella, of the CIBER Fisiopatologia de la Obesidad y Nutrici?n, says, however, results showed that when adherence to the Mediterranean diet was high, having two copies of the gene variant bared no significance on fasting glucose levels.

She adds:

"The same was true for three common measures of cardiovascular disease risk: total blood cholesterol, low density lipoprotein and triglycerides."

"Conversely, these risk factors were considerably higher in homozygous carriers with low adherence to the diet."

Previous research has also revealed that following a Mediterranean diet can benefit health. A study from the University of Alabama at Birmingham suggested that following a Mediterranean diet may improve memory and thinking.

Researchers from Spain have suggested the diet may help protect the health of bones.

The Mayo Clinic offers a recommendation of key components that make up a healthy Mediterranean diet. These include:

Eating primarily plant-based foods, such as fruit, vegetables, whole grains, legumes and nutsReplacing butter with healthy fats, such as olive oilUsing herbs and spices instead of salt to flavor foodsLimiting red meat to no more than a few times a monthDrinking red wine in moderation (optional).

The researchers in the current Spanish study would like to see more studies to determine how our genes and the Mediterranean diet work together.

Written by Honor Whiteman

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Stroke declines dramatically, still higher in Mexican Americans

Main Category: Stroke
Article Date: 14 Aug 2013 - 0:00 PDT Current ratings for:
Stroke declines dramatically, still higher in Mexican Americans

A new study reports that the incidence of ischemic stroke - the most common type of stroke, caused by a clot in the blood vessels of the brain - among non-Hispanic Whites and Mexican Americans over age 60 has declined over the past decade. Most concerning, however, is that the increased relative burden of stroke comparing Mexican Americans and non-Hispanic Whites has not changed at all in the last decade. Overall, Mexican Americans suffer much more, 34%, from this disease than non-Hispanic Whites. Findings are published in Annals of Neurology, a journal of the American Neurological Association and Child Neurology Society.

Hispanic/Latinos are now the largest minority group in the U.S. at 17% of the population, which is projected to increase to more than 30% by 2050, according to estimates from the January 2013 U.S. Census. Previous research found that Mexican Americans had higher stroke rates than non-Hispanic Whites and as this population ages it raises concern for the impact on public health. In fact, experts estimate that the cost of stroke for the first half of this century in the U.S. could amount to more than $1.5 trillion dollars.

"In minority groups stroke occurs at much younger ages, often resulting in greater disability and significantly higher costs," explains lead author, Dr. Lewis B. Morgenstern from the University of Michigan Medical School in Ann Arbor. "With stroke causing such a personal, family and economic burden in minorities, our study focuses on Mexican Americans - one of the largest and fastest growing segments of the U.S. population."

For the present study, researchers conducted a population-based study of stroke trends in subjects 45 years of age and older living in Corpus Christi, Texas, between January 2000 and December 2010. Two-thirds of this community were Mexican American and the remainder primarily non-Hispanic White, with 87% born in the U.S., 11% in Mexico, and 1% who did not know their country of birth. Those born in Mexico have lived in the U.S. an average of 52 years.

Results show ischemic stroke occurred in 2,604 Mexican Americans and 2,042 non-Hispanic Whites, representing a 36% decline for the study period. Analysis found that the decline was limited to those 60 years of age and over and was evident in both ethnic populations. The disparity between Mexican American and non-Hispanic White stroke rates in those 45-74 years of age remained.

"The dramatic decline in stroke rates during the last decade is encouraging," concludes Dr. Morgenstern. "However, the ongoing disparity among younger patients emphasizes the need for further interventions to prevent stroke, particularly among young Mexican Americans."

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

Persistent Ischemic Stroke Incidence Disparities in Mexican Americans

Annals of Neurology; Published online: August 13, 2013 (DOI:10.1002/ana.23972).

Lewis B. Morgenstern, Melinda A. Smith, Brisa N. Sanchez, Devin L. Brown, Darin B. Zahuranec, Nelda Garcia, Kevin A. Kerber, Lesli E. Skolarus, William J Meurer James F Burke, Eric E. Adelman, Jonggyu Baek and Lynda D. Lisabeth.

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The blood vessels of the retina can reveal stroke risk

Main Category: Hypertension
Also Included In: Eye Health / Blindness;  Stroke
Article Date: 14 Aug 2013 - 0:00 PDT Current ratings for:
The blood vessels of the retina can reveal stroke risk

Your eyes may be a window to your stroke risk.

In a study reported in the American Heart Association journal Hypertension, researchers said retinal imaging may someday help assess if you're more likely to develop a stroke - the nation's No. 4 killer and a leading cause of disability.

"The retina provides information on the status of blood vessels in the brain," said Mohammad Kamran Ikram, M.D., Ph.D., lead author of the study and assistant professor in the Singapore Eye Research Institute, the Department of Ophthalmology and Memory Aging & Cognition Centre, at the National University of Singapore. "Retinal imaging is a non-invasive and cheap way of examining the blood vessels of the retina."

Worldwide, high blood pressure is the single most important risk factor for stroke. However, it's still not possible to predict which high blood pressure patients are most likely to develop a stroke.

Researchers tracked stroke occurrence for an average 13 years in 2,907 patients with high blood pressure who had not previously experienced a stroke. At baseline, each had photographs taken of the retina, the light-sensitive layer of cells at the back of the eyeball. Damage to the retinal blood vessels attributed to hypertension - called hypertensive retinopathy - evident on the photographs was scored as none, mild or moderate/severe.

During the follow-up, 146 participants experienced a stroke caused by a blood clot and 15 by bleeding in the brain.

Researchers adjusted for several stroke risk factors such as age, sex, race, cholesterol levels, blood sugar, body mass index, smoking and blood pressure readings. They found the risk of stroke was 35 percent higher in those with mild hypertensive retinopathy and 137 percent higher in those with moderate or severe hypertensive retinopathy.

Even in patients on medication and achieving good blood pressure control, the risk of a blood clot was 96 percent higher in those with mild hypertensive retinopathy and 198 percent higher in those with moderate or severe hypertensive retinopathy.

"It is too early to recommend changes in clinical practice," Ikram said. "Other studies need to confirm our findings and examine whether retinal imaging can be useful in providing additional information about stroke risk in people with high blood pressure."

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

The National Heart, Lung, and Blood Institute funded the study.

Hypertensive Retinopathy and Risk of Stroke

Yi-Ting Ong, Tien Y. Wong, Ronald Klein, Barbara E.K. Klein, Paul Mitchell, A. Richey Sharrett, David J. Couper, M. Kamran Ikram. Hypertension. 2013; published online before print August 12 2013, doi:10.1161/HYPERTENSIONAHA.113.01414

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Emergency physicians distinguish between Bell's palsy and stroke

Main Category: Stroke
Also Included In: Neurology / Neuroscience
Article Date: 29 Jul 2013 - 1:00 PDT Current ratings for:
Emergency physicians distinguish between Bell's palsy and stroke

Emergency physicians correctly identified nearly 100 percent of patients with Bell's palsy, the symptoms of which are nearly identical to potentially life-threatening diseases such as stroke and brain tumors. The results of a study of 6 years of California patient records were published online yesterday in Annals of Emergency Medicine ("Potential Misdiagnoses of Bell's Palsy in the Emergency Department").

"Even lacking established guidelines for diagnosing Bell's palsy, which is the most common cause of paralysis of one side of the face, emergency physicians make the right call nearly every time," said lead study author Jahan Fahimi, MD, MPH, of Alameda County Medical Center in Oakland, Calif. and the University of California, San Francisco. "The dramatic and distressing nature of facial paralysis often brings patients to the ER for evaluation, often with a concern that they are having a stroke. The combination of thorough history-taking and detailed physical exam allows emergency physicians to determine which patients have a dangerous condition and which can safely be discharged home. While there may be a role for imaging, such as CT or MRI, the overwhelming majority of patients can be evaluated without advanced diagnostic tests."

Researchers analyzed 43,979 records for patients discharged from California emergency departments with a diagnosis of Bell's palsy. At 90-day follow up, 0.8 percent of those patients received an alternate diagnosis, such as stroke, brain bleed, brain tumor, central nervous system infection, Guillain-Barre syndrome, Lyme disease, ear infection or herpes zoster. When restricted to only life-threatening alternative diagnoses associated with central facial paralysis, only 0.3 percent were misdiagnosed.

Patients with Bell's palsy commonly manifest partial or complete weakness of the muscles of half of the face, resulting in an inability to raise one eyebrow, wrinkle their foreheads or close one eyelid. Symptoms often progress fairly rapidly and strongly mimic the symptoms of certain types of stroke. It affects approximately 15 people out of 100,000 every year.

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Gender gap in stroke treatment likely due to delay by women seeking care

Main Category: Stroke
Also Included In: Women's Health / Gynecology
Article Date: 29 Jul 2013 - 0:00 PDT Current ratings for:
Gender gap in stroke treatment likely due to delay by women seeking care

Women with clot-caused strokes are less likely than men to arrive at the hospital in time to receive the best treatment, according to a European study reported in the American Heart Association journal Stroke.

In the study, 11 percent of women with acute ischemic strokes were treated with the clot-dissolving medication alteplase, compared with 14 percent of men. Study participants included 5,515 patients at 12 hospitals in the Netherlands.

Researchers found no gender gap when they looked only at patients who arrived at the hospital within four hours of the onset of symptoms in this study. Forty-two percent of men and women arriving within the four-hour window received alteplase.

"Our study showed that women in the Netherlands were treated just as often with thrombolytic agents as men once they arrived in time for treatment," said Inger de Ridder, M.D., lead author of the study and AIOS Resident of Neurology at Erasmus University Medical Center in Rotterdam, The Netherlands.

The gender gap in treatment may be due to delays in getting to the hospital, researchers said. Women arrived at the hospital an average 27 minutes later than men, and a smaller percentage of women (27 percent) than men (33 percent) arrived at the hospital within the four-hour window.

Furthermore, women in the study were an average four years older and may consequently have been more likely to live alone, which would make it more difficult to summon help. Stroke severity was similar for men and women.

"More education about stroke symptoms is needed, and also more research to find out why women arrive later at the hospital," de Ridder said.

The findings may also apply to patients in the United States, researchers said.

Stroke symptoms include: drooping or numbness in the face; weakness or numbness in the arms; and speech difficulty. Stroke is the No. 4 cause of death and the leading preventable cause of disability in the United States.

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

Unequal Access to Treatment With Intravenous Alteplase for Women With Acute Ischemic Stroke, Inger de Ridder, MD, Maaike Dirks, MD, PhD, Louis Niessen, MD, PhD, Diederik Dippel, MD, PhD and on behalf of the PRACTISE Investigators, Published online before print July 25, 2013, doi: 10.1161/?STROKEAHA.113.002263

Author disclosures are on the manuscript.

The Netherlands Organization for Health Research and Development funded the study.

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Stem cell discovery: Astrocytes could repair stroke brain damage

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Academic Journal
Main Category: Stroke
Also Included In: Neurology / Neuroscience;  Stem Cell Research
Article Date: 29 Jul 2013 - 0:00 PDT Current ratings for:
Stem cell discovery: Astrocytes could repair stroke brain damage

Stem cell researchers have discovered that astrocytes may prove useful against stroke and other brain disorders.

Astrocytes - neural cells that form the blood-brain barrier and so control what can and cannot enter the brain from the blood supply - have previously been overlooked in this area of stroke research.

A collaborative study published in Nature Communications suggests that astrocytes can do far more than simply support nerve cells (neurons).

Wenbin Deng, senior author of the study and associate professor of biochemistry and molecular medicine at UC Davis in California, told Medical News Today:

"This exciting research uncovers the brain-protective powers of stem cell-derived astrocytes.

Astrocytes may help to limit the spread of damage after an ischemic brain stroke in patients, and may also help to regenerate and repair damaged brain cells.

Both of these actions may lead to better functional recovery in patients."

Dr. Wenbin Deng added that astrocyte-centered therapy "could also be used for many other nervous system disorders." He said the following could be included in a list of potential targets for therapy:

Stem cell research has focused until now on developing stroke treatments using therapeutic neurons to stimulate electrical impulses in the brain, and restore tissue that has been damaged by oxygen deprivation. Dr. Wenbin Deng said astrocytes had often been considered just "housekeeping" cells that merely support nerve cells.

An astrocyte - more useful than previously thought. Courtesy Dr. Peng Jiang

"But they're actually much more sophisticated," Dr. Wenbin Deng explained. "They are critical to several brain functions and are believed to protect neurons from injury and death. They are not excitable cells like neurons and are easier to harness. We wanted to explore their potential in treating neurological disorders, beginning with stroke."

The UC Davis team faced an immediate challenge, however - there was little existing understanding on which specific types of astrocyte might have therapeutic potential in brain disorders. Also, the principal reason astrocytes had not been investigated in this context was the difficulty in producing them to the purity levels needed for stem cell therapies.

The UC Davis team decided to use a transcription factor protein called Olig2 to differentiate human embryonic stem cells into astrocytes. This approach generated a previously undiscovered type of astrocyte called Olig2PC-Astros - it was almost 100% pure.

"In this study, we report a surprising twist of fate," Dr. Wenbin Deng told MNT. He added:

"Our novel findings are that highly purified Olig2+ progenitors can give rise to astrocytes and that these astrocytes derived from highly purified Olig2+ progenitors are different from the astrocytes described in any previous work."

In short, the team's quest for a sufficiently pure astrocyte had, by serendipity, also led them to isolate a previously unknown astrocyte with particularly therapeutic properties.

Researchers used three groups of rats with ischemic brain injuries to compare the effects of Olig2PC-Astros, another type of astrocyte called NPC-Astros, and no treatment. The animals were placed in a water maze to assess their learning and memory.

Two weeks after transplantation, the rats receiving Olig2PC-Astros navigated the maze significantly quicker than the other groups. This group also exhibited higher levels of brain-derived neurotrophic factor (BDNF), a protein associated with nerve growth and resilience.

Cell cultures were also used to measure what protection the astrocytes could provide to neurons against the oxidative stress that contributes to brain injury following stroke.

When exposed to hydrogen peroxide, both types of astrocytes provided some protection but the Olig2PC-Astros showed greater antioxidant effects. Further investigation indicated higher levels of the protein Nrf2, which increases antioxidant activity in mouse neurons.

Additionally, the Olig2PC-Astros cells remained in brain areas where they were transplanted, did not differentiate into neurons or other cell types and formed no tumors.

Jan Nolta, director of the UC Davis Institute for Regenerative Cures, commented: "Dr. Deng's team has shown that this new method for deriving astrocytes from embryonic stem cells creates a cell population that is more pure and functionally superior to the standard method for astrocyte derivation."

Jan Nolta added:

"The functional improvement seen in the brain injury models is impressive, as are the higher levels of BDNF.

I will be excited to see this work extended to other brain disease models such as Huntington's disease and others, where it is known that BDNF has a positive effect."

Written by Nick Valentine

Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today Visit our stroke section for the latest news on this subject. "hESC-derived Olig2+ progenitors generate a subtype of astroglia with protective effects against ischaemic brain injury," Nature Communications, 23 July 2013. Full text Please use one of the following formats to cite this article in your essay, paper or report:

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Finding may lead to new treatments for neurodegenerative disease and stroke

Main Category: Neurology / Neuroscience
Also Included In: Stroke;  Rehabilitation / Physical Therapy
Article Date: 25 Jul 2013 - 1:00 PDT Current ratings for:
Finding may lead to new treatments for neurodegenerative disease and stroke

In degenerative brain diseases and after stroke, nerve cells die while their support cells activate the brain's immune system to cause further damage. Now Jonathan Gilthorpe, Adrian Pini and Andrew Lumsden at the MRC Centre for Developmental Neurobiology at King's College London, have found that a single protein, histone H1, causes these distinct outcomes.

The research passed peer review within a week of being published in F1000Research, where Jan-Marino Ramirez, of the University of Washington, called the work "a very important contribution to our understanding of neurodegenerative disease and the response of the brain to injury" in his public referee report. He also noted that he is "confident that this study will be a much cited contribution to the field of traumatic brain injury".

The most unexpected finding in this study is that a histone protein is responsible for neuronal damage. "Histone H1 partners with DNA in the cell nucleus and has been thought of as harmless," explain the authors, "The surprise came when we discovered that it can be released from brain cells upon injury, killing healthy nerve cells and activating the damaging immune response".

The research team is now working on ways to suppress these harmful actions, which may lead to the development of new treatments for neurodegenerative disease and stroke.

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

Extracellular histone H1 is neurotoxic and drives a pro-inflammatory response in microglia [v1; ref status: indexed] F1000Research 2013, 2:148 (doi: 10.12688/f1000research.2-148.v1)

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