Athersys Inc (ATHXQ)

[jeffsimon99]

New S.A. article re: Athersys. Here is the link to read it.

http://seekingalpha.com/article/3031446-date-and-time-is-set-for-athersys-phase-ii-stroke-presentation?app=1&auth_param=s4hu7:1ah8jqs:09a877cba2d69dc28c4d4eff919bff4f&uprof=46&dr=1


Date And Time Is Set For Athersys Phase II Stroke Presentation
Mar. 26, 2015 2:25 PM ET | About: Athersys, Inc. (ATHX)
Disclosure: The author is long ATHX. (More...)
Summary
Phase II Stroke Data to be Presented April 19th 8:50 AM in Glasgow, UK.
Recent Weakness Represents a Better Entry Point.
The Science Behind the Stroke Trial is Substantial.
Although there has been no formal press release by Athersys (NASDAQ:ATHX), the exact time and date of its highly anticipated stroke results has been set. The data will be presented for April 19th at 8:50 local time in Glasgow, UK at the European Stroke Orginisation Conference 2015. Here is a copy of the program details along with the link:

SCIENTIFIC PROGRAMMESC18 Scientific Communications (Oral Abstract Presentations)
CLINICAL TRIALS
19-Apr-2015 08:30 10:00

Abstract:
RESULTS OF THE DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PHASE 2 SAFETY AND EFFICACY TRIAL OF MULTISTEM® IN ADULTS WITH ISCHEMIC STROKE
BACKGROUND: MultiStem® is an adult, adherent, stem cell product, having shown safety and efficacy in other clinical indications. We assessed whether it was safe and improved functional outcome in patients with ischemic stroke.
METHODS: This was a double-blind, placebo-controlled trial of ischemic stroke patients (NIHSS 8-20, inclusive) treated within 24-48 hours of symptoms at 33 U.S. and U.K. sites. Following a dose escalation phase, patients were randomized 1:1 to receive intravenous infusion of MultiStem® or placebo. The primary efficacy endpoint was Global Stroke Recovery at Day 90 (a test statistic combining modified Rankin Scale =2; NIHSS total score improvement of =75% from baseline; Barthel Index =95) in the MultiStem group compared to placebo group. Secondary and exploratory efficacy endpoints included: modified Rankin Scale by shift analysis at Day 90, changes in cortical infarct volume measured by MRI, and changes in blood markers (white blood cell populations and cytokines) from baseline to Day 30. Safety end points included adverse events or neurologic worsening through 7 days post-infusion, the incidence of secondary infections, differences in adverse events, mortality and vital signs through Day 365 between the treatment groups.
RESULTS: Patients were enrolled from November, 2011, to December, 2014. In the dose escalation phase, both doses were well tolerated and safe and the high dose of 1200 million cells was chosen. 126 patients formed the modified Intention To Treat population, 65 receiving MultiStem®, 61 receiving placebo. Results on the primary, secondary and exploratory efficacy and safety outcomes will be presented during the conference.

Co-authors
D.C. Hess1, W.D. Clark2, D. Chiu3, L.R. Wechsler4, K. Uchino5, A.P. Auchus6, C.A. Sila7, A.J. Furlan7, J.A. Switzer1, R.W. Mays8.
1Neurology, Georgia Reagents University, Augusta, USA.
2Neurology, Oregon Health Sciences University, Portland, USA.
3Neurology, Houston Methodist, Houston, USA.
4Neurology, University of Pittsburgh Medical Center, Pittsburgh, USA.
5Neurology, Cleveland Clinic, Cleveland, USA.
6Neurology, University of Mississippi, Jackson, USA.
7Neurology, Case Western Reserve University Hospital, Cleveland, USA.
8Regenerative Medicine, Athersys Inc., Cleveland, USA.
eso.kenes.com/scientific-programme/scientific-programme-2#.VRQKxvnF-T8
My thoughts and extensive research on this trial can be found in the following articles on Seeking Alpha and there is no need to rewrite these thoughts again:

Athersys Down But Not Out - An Interview With CEO Van Bokkelen

Athersys Could Benefit Immensely From Japan Reimbursement On Stroke

It is my position that the weakness in the biotech sector over the last couple of days presents a great opportunity for investors to establish a position, as Athersys shares have declined sharply from recent highs. I do not believe the backtracking in shares has anything to do with the stroke results, which according to Athersys, are to be unblinded shortly before the conference. However, this is not an investment for those who do not understand the risk or perform their own due diligence.

There are those who are playing the short side of this trade ahead of the results, and they like to play on these fears and point to the failure of MultiStem in showing efficacy in an ulcerative colitis trial run by Pfizer. Although there doesn't seem to be a big short contingent, as the cost to borrow shares has not changed much over the last few weeks and now sits at about 4.75% with about 550,000 shares available at Fidelity, one of the "concerns" I have seen put out there by the short side is that any efficacy at 30 days may not be sustainable at 90 days (the primary endpoint for the trial). Based on the mechanism of action, if MultiStem improves patient outcomes at 30 days, this improvement will not likely be lost at 90 days. The basis for this belief is the pre-clinical research that shows that the first week following a stroke is the period of time when much damage is done to the brain by the over inflammatory response of the spleen. The role of the spleen is also confirmed in this research in actual stroke patients. The spleen's overreaction is mitigated by MultiStem by shutting down the brain/blood barrier. Once the patient gets beyond this stage, the neurotrophic factors start to kick in and hopefully provide further benefit, as some level of healing takes place and new blood vessels begin to form. By the 30th day the bulk, if not all, of the potential secondary damage threat from the spleen has passed. So there is little reason to believe that improvement at 30 days would not be sustainable at 90 days.

Stroke is an acute injury and not comparable to ulcerative colitis, a chronic systemic disease that may need multiple dosing to get over the hump. Although we can't know for sure if multiple doses would have worked for ulcerative colitis until another double blinded placebo controlled trial is commenced.

The stakes are high here, not only for investors but for stroke patients and the regenerative medicine field, in general. Recently Chugai Pharmaceutical Co., Ltd. paid Athersys $10,000,000 up front for the exclusive rights to market MultiStem for stroke in Japan in a deal worth about $195,000,000 in milestone payments and generous royalties to Athersys based upon success. Chugai is a subsidiary of major Swiss based pharmaceutical company Roche and has been involved in talks with Athersys for over a year before pulling the trigger. The scientists at Chugai have surely done an incredible amount of due diligence on this therapy.

It is human nature to look at every move up and down in the share price as a validation or a warning for shortly upcoming clinical results and short sellers are certain to try and prey on this fear when shares decline in advance of results. No one can guarantee a positive outcome but I remain long and optimistic. We will all have the answers no later than 4:50AM EST on April 19th.