Athersys ($ATHX) holds meeting with FDA to discuss MultiStem

Athersys announced that a scheduled meeting with the FDA was held to discuss the results of its recently completed clinical trial involving the administration of MultiStem to patients being treated for leukemia or other conditions that place them at risk of Graft versus Host Disease (GvHD).

• Additionally, the company discussed with the FDA its proposed plans for the next phase of clinical development, answered questions and obtained feedback on a number of specific issues related to the potential study parameters and proposed trial design.
• The company intends to provide further information about its plans as it finalizes development of a detailed trial and statistical plan and receives additional FDA feedback.

Athersys ($ATHX) announces publication in Cell Transplantation

Athersys announced the publication in the scientific journal, Cell Transplantation, of an article that describes the results of a preclinical study evaluating the administration of MultiStem for the treatment of MPS-I.
• The article, authored by investigators at the University of Minnesota together with scientists from Athersys, describes preclinical study results suggesting that the stem cells could provide benefit to patients suffering from lysosomal storage disorders, such as Hurler's Syndrome.
• The published study demonstrates that an injection of MultiStem cells in neonatal MPS-I mice reduces the accumulation of GAGs in the brain thereby resulting in improvements in behavioral and motor function in the diseased mice.
• The company also announced the issuance of U.S. patent 7,927,587, which covers the use of non-embryonic, multipotent stem cells for the treatment of lysosomal storage diseases.
• The patent applies to Hurler's Syndrome and other lysosomal storage disorders, such as Fabry's disease, Gaucher's disease, Niemann-Pick disease and Batten's disease, among many others.

Athersys ($ATHX): Another Patent, GvHD

Athersys has obtained a U.S patent for its MultiStem technology, a stem cell treatment for graft-versus-host disease that employs cells from adult bone marrow and other nonembryonic sources. The product has shown the ability to limit inflammation, protect impaired tissue and aid in the formation of new blood vessels.

See the full press release.

Flash Player 9 or higher is required to view the chart
Click here to download Flash Player now

View the full ATHX chart at Wikinvest

DD Education: Which Cell Therapy companies present the best value? Part 2

We developed an analysis using public filings and annualizing the most recent quarters as of 12/31/11. As such, the accuracy is subjective to our proprietary algorithm, and this list is not mean to be all comprehensive.

We conclude that ex leaders Dendreon and MesoBlast make the space very inexpensive. The sample below represents just over $500 million in market cap for eight of the selected public companies (ex DNDN and MSB). These companies have 3 - PIII trials, 5 PII trials and several P1 trials (based on these crude metrics).

We conclude that is worth investors time to understand among these companies in terms of what they are doing and the associated probabilities of success of their trials. Recent data peaks from the Cardiology space suggests that Baxter (BAX) and their CD34 cell type may be very viable. NeoStem has a very similar approach. The retrenchment in MesoBlast shares since that company presented data at AHA in November is of concern. Cytori, Aastrom, Athersys all have active programs in cardiology while Athersys lead program is partnered with Pfizer for Ulcerative Colitis and Aastrom is entering a Phase 3 trial in CLI.

By price ($), Osiris, MesoBlast, and Dendreon are the highest $ priced stocks:

But that starts to change as we migrate to market cap:

And if we eliminate Mesoblast and Dendreon we get a better picture of the rest of the field:

And that picture changes as we adjust for debt and cash: (enterprise value). In all fairness here, we know that NeoStem with $20-$30 million in value from their China generic company, could be the cheapest name and others are / will raise capital but ex China, Athersys is the “cheapest name”.

Looking at R&D spending: IMUC, Prima and NeoStem are among the most efficient but in fairness one must adjust for the fact that Aastrom is embarking on a pivotal trial versus Prima just starting their P3 and NeoStem their P2.

Revenues: Here we have excluded NeoStem’s $65 million from China which means PCT (Cell Therapy CMO) is running at close to $10 million in annual revenues (currently).

Which Cell Therapy companies present the best value?

In the wake of a robust season of financings, and low valuations we revisit the basic questions in the cell therapy space, updating our tables for year end reported financials. Our numbers are forward looking and subjective to our proprietary algorithm, and this list is not mean to be all comprehensive.

Dendreon and MesoBlast remain the market leaders, but the best values by far are in the micro-cap space with names like Aastrom and PluriStem funded with strong balance sheets.

The sample below represents just over $875 million in market cap for eight of the selected public companies (ex DNDN and MSB). These companies have 3 - PIII trials, 5 PII trials and several P1 trials (based on these crude metrics).

We conclude that is worth investors time to understand among these companies in terms of what they are doing and the associated probabilities of success of their trials.

By price ($), Osiris, MesoBlast, and Dendreon are the highest $ priced stocks: 

By Price ($), Osiris , MesoBlast and Dendreon are the highest $ price:

But that starts to change as we migrate to market cap:

And if we eliminate Mesoblast and Dendreon we get a better picture of the rest of the field:

And that picture changes as we adjust for debt and cash (enterprise value):

Looking at R&D spend gives us an idea of who is spending what on clinical programs:

ATHX Athersys initiated overweight at Piper Jaffray ($1.67)

Athersys (NASDAQ: ATHX) initiated overweight at Piper Jaffray ($1.67).

• Target is $4

• Analyst is Edward Tenthoff

Athersys is a clinical stage biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem^(R) cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas. The Company currently has several clinical stage programs involving MultiStem, including for treating inflammatory bowel disease, ischemic stroke, damage caused by myocardial infarction, and for the prevention of graft versus host disease. Athersys has also developed a diverse portfolio that includes other technologies and product development opportunities, and has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions in the United States and Europe to further develop its platform and products. More information is available at www.athersys.com.

Flash Player 9 or higher is required to view the chart
Click here to download Flash Player now

View the full ATHX chart at Wikinvest

Athersys Announces Private Placement Financing - $ATHX

Athersys, Inc. (Nasdaq:ATHX), a leader in the emerging field of regenerative medicine, today announced that it has entered into definitive agreements with certain accredited investors in connection with a private placement financing transaction. Upon the closing of the transaction, Athersys will receive gross proceeds of approximately $9.0 million in exchange for the issuance of approximately 4,347,827 shares of Athersys common stock and warrants to purchase approximately 4,347,827 shares of Athersys common stock. The warrants will be exercisable for a period of five years at an exercise price of $2.07 per share. Athersys intends to use the net proceeds of the transaction to support its ongoing business development and clinical efforts, and for general corporate purposes.

Piper Jaffray & Co. acted as sole lead placement agent for the offering, William Blair & Company and First Analysis Securities Corporation acted as co-placement agents and WBB Securities, LLC acted as financial advisor.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Full press release

Flash Player 9 or higher is required to view the chart
Click here to download Flash Player now

View the full ATHX chart at Wikinvest

BBC: Stem cells used to 'heal' heart attack scars

An exciting article appeared in the BBC many weeks ago, and continues to cycle through the media. It has to do with some exciting but early work done in the area of expanding heart cells (myocytes).

_________________________________

Damage caused by a heart attack has been healed using stem cells gathered from the patient's own heart, according to doctors in the US.

The amount of scar tissue was halved in the small safety trial reported in the Lancet medical journal.

The authors said there was also an "unprecedented" increase in new heart muscle.

The British Heart Foundation said it was "early days", but could "be great news for heart attack patients". A heart attack happens when the organ is starved of oxygen, such as a clot blocking the flow of blood to the heart.

As the heart heals, the dead muscle is replaced with scar tissue, but because this does not beat like heart muscle the ability to pump blood around the body is reduced.

Doctors around the world are looking at ways of "regenerating" the heart to replace the scar tissue with beating muscle. Stem cells, which can transform into any other type of specialised cell, figure prominently in their plans.

Heart to heart

This trial, at the Cedars-Sinai Heart Institute, was designed to test the safety of using stem cells taken from a heart attack patient's own heart.

Healing the Heart

This is the second group of doctors to report using cells taken from a heart to heal a heart. In November 2011, another safety trial showed the cells could be used to heal the hearts of heart failure patients who were having heart bypass surgery. The heart is not the only source for these stem cells and other fields are much further ahead.

The largest ever trial of stem cell therapy in heart attack patients is about to get under way in Europe. The BAMI trial will inject 3,000 heart attack patients with stem cells taken from their bone marrow within five days of the heart attack.  {(We know a little bit about this trial, it is based on bone marrow derrived cells that home to the peri-infarc zone via an ischemic gradient.  This is very similar to the mechanism of action that NeoStem's (NBS) Amorcyte claims on their bone marrow derrived cells (CD 34+ /CXCR4+) enriched marrow cells, injected into the IRA (infarc related artery). The BAMI trial is similar in design to NBS trial but with a few major differences. The product is not enriiched for CD 34+ cells and the dose is not as concentrated).}

• Cardiac cells 'heal heart damage'

Within a month of a heart attack, a tube was inserted into a vein in the patient's neck and was pushed down towards the heart. A sample of heart tissue, about "half the size of a raisin", was taken. This was taken to the laboratory where the stem cells were isolated and grown. Up to 25 million of these stem cells were then put into the arteries surrounding the heart. Twenty five patients took part in the trial. Before the treatment, scar tissue accounted for an average of 24% of their left ventricle, a major chamber of the heart. It went down to 16% after six months and 12% after a year. Healthy heart muscle appeared to take its place. The study said the cells, "have an unprecedented ability to reduce scar and simultaneously stimulate the regrowth of healthy [heart] tissue".

One of the researchers Dr Eduardo Marban said: "While the primary goal of our study was to verify safety, we also looked for evidence that the treatment might dissolve scar and regrow lost heart muscle. "This has never been accomplished before, despite a decade of cell therapy trials for patients with heart attacks. Now we have done it. "The effects are substantial, and surprisingly larger in humans than they were in animal tests."

 Dr. Iqbal Malik: ''This is one small step''

However, there was no increase in a significant measure of the heart's ability to pump - the left ventricle ejection fraction: the percentage of blood pumped out of the left ventricle.

Prof Anthony Mathur, who is co-ordinating a stem cell trial involving 3,000 heart attack patients, said that even if the study found an increase in ejection fraction then it would be the source of much debate.

He argued that as it was a proof-of-concept study, with a small group of patients, "proving it is safe and feasible is all you can ask".

"The findings would be very interesting, but obviously they need further clarification and evidence," he added. Prof Jeremy Pearson, associate medical director at the British Heart Foundation, said: "It's the first time these scientists' potentially exciting work has been carried out in humans, and the results are very encouraging. "These cells have been proven to form heart muscle in a petri dish but now they seem to be doing the same thing when injected back into the heart as part of an apparently safe procedure.

"It's early days, and this research will certainly need following up, but it could be great news for heart attack patients who face the debilitating symptoms of heart failure."