Has anybody seen anything on this?
Kaplan Fox Investigates
Osiris Therapeutics, Inc. - Kaplan Fox Investigates Possible Securities Laws Violations
New York ? April 3, 2009 ? Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) has been investigating Osiris Therapeutics, Inc. (?Osiris? or the ?Company?) (NasdaqGM: OSIR) for potential violations of the federal securities laws.
In January 2007, Osiris received Fast Track designation from the U.S. Food and Drug Administration, expediting the development of a stem cell treatment for Crohn?s Disease that does not respond to standard therapies. The Phase III study commenced in May 2007.
On March 27, 2009 before the market opened, Osiris announced that it had elected to end enrollment in its Phase III trial evaluating Prochymal for Crohn?s disease, which by that point had enrolled 210 of the targeted 270 patients, due to a ?design flaw in the trial resulting in significantly higher than expected placebo response rates.? Osiris described the design flaw as follows:
The potential trial design flaw may be related to the fact that patients responding to the initial therapy were eligible to participate in a second, longer-term trial evaluating Prochymal as a maintenance therapy. Because the current standard for determining response of Crohn?s patients to therapy is largely subjective, there may have been a bias to meet the eligibility requirements for continuation of therapy in the longer-term maintenance trial.
Also on March 27, Osiris held a conference call with investors. In response to a question requesting ?help? in understanding the design flaw, CEO Randy Mills stated that ?the actual design flaw came in that these patients even if they weren?t . . . feeling better, basically we gave them incentive to say they were feeling better because they would then have an opportunity to get drug in the maintenance trial.?
On March 27, 2009, the day of the announcement, Osiris?s common stock declined by more than 21% on heavier than usual volume.
This case may affect purchasers of securities as early as January 2007. If you purchased Osiris?s publicly traded securities and would like to discuss our investigation, please e-mail us at mail@kaplanfox.com or contact:
Frederic S. Fox
Joel B. Strauss
Donald R. Hall
Jeffrey P. Campisi
Pamela A. Mayer
KAPLAN FOX & KILSHEIMER LLP
850 Third Avenue, 14th Floor
New York, New York 10022
(800) 290-1952
(212) 687-1980
Fax: (212) 687-7714
E-mail address: mail@kaplanfox.com
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
350 Sansome Street, Suite 400
San Francisco, California 94104
(415) 772-4700
Fax: (415) 772-4707
E-mail address: mail@kaplanfox.com
Kaplan Fox Investigates
Osiris Therapeutics, Inc. - Kaplan Fox Investigates Possible Securities Laws Violations
New York ? April 3, 2009 ? Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) has been investigating Osiris Therapeutics, Inc. (?Osiris? or the ?Company?) (NasdaqGM: OSIR) for potential violations of the federal securities laws.
In January 2007, Osiris received Fast Track designation from the U.S. Food and Drug Administration, expediting the development of a stem cell treatment for Crohn?s Disease that does not respond to standard therapies. The Phase III study commenced in May 2007.
On March 27, 2009 before the market opened, Osiris announced that it had elected to end enrollment in its Phase III trial evaluating Prochymal for Crohn?s disease, which by that point had enrolled 210 of the targeted 270 patients, due to a ?design flaw in the trial resulting in significantly higher than expected placebo response rates.? Osiris described the design flaw as follows:
The potential trial design flaw may be related to the fact that patients responding to the initial therapy were eligible to participate in a second, longer-term trial evaluating Prochymal as a maintenance therapy. Because the current standard for determining response of Crohn?s patients to therapy is largely subjective, there may have been a bias to meet the eligibility requirements for continuation of therapy in the longer-term maintenance trial.
Also on March 27, Osiris held a conference call with investors. In response to a question requesting ?help? in understanding the design flaw, CEO Randy Mills stated that ?the actual design flaw came in that these patients even if they weren?t . . . feeling better, basically we gave them incentive to say they were feeling better because they would then have an opportunity to get drug in the maintenance trial.?
On March 27, 2009, the day of the announcement, Osiris?s common stock declined by more than 21% on heavier than usual volume.
This case may affect purchasers of securities as early as January 2007. If you purchased Osiris?s publicly traded securities and would like to discuss our investigation, please e-mail us at mail@kaplanfox.com or contact:
Frederic S. Fox
Joel B. Strauss
Donald R. Hall
Jeffrey P. Campisi
Pamela A. Mayer
KAPLAN FOX & KILSHEIMER LLP
850 Third Avenue, 14th Floor
New York, New York 10022
(800) 290-1952
(212) 687-1980
Fax: (212) 687-7714
E-mail address: mail@kaplanfox.com
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
350 Sansome Street, Suite 400
San Francisco, California 94104
(415) 772-4700
Fax: (415) 772-4707
E-mail address: mail@kaplanfox.com