Osiris Discontinues Enrollment in Crohn?s Study

[danny]

Osiris Discontinues Enrollment in Crohn?s Study Due to
Concerns with Trial Design

** I have a great idea..scew the trial and give everyone the dang drug!!

Drug safety not a factor in decision
COLUMBIA, Maryland ? March 27, 2009 ? Osiris Therapeutics, Inc. (NASDAQ: OSIR) announced today that it has elected to end enrollment at 210 patients in its Phase III trial evaluating Prochymal for Crohn?s
disease. The Company believes there is a design flaw in the trial resulting in significantly higher than expected placebo response rates. The decision was made after the trial?s final scheduled interim analysis
showed that one of the two Prochymal dose arms had crossed a futility boundary. The dose arm was unlikely to achieve the primary endpoint of remission because of the high placebo response rate. This latest analysis
continued to show no serious safety concerns with the therapy and safety was not a factor in the decision to stop enrollment.
C. Randal Mills, Ph.D. President and CEO of Osiris Therapeutics said, ?We had a situation where we were experiencing much higher than expected placebo response rates. As we looked into possible causes, we
discovered what we believe to be a systemic design flaw in the trial that would likely affect the utility of the data for purposes of registration. After careful discussion with the FDA, we elected to discontinue enrollment
rather than attempt to re-power the trial. We will keep the trial blinded and expect a solid data package for use in designing future trials in Crohn?s disease and to bolster Prochymal?s safety database.?
Mills continued, ?I would like to personally thank the physicians, study professionals, and of course the patients who have dedicated their time to this trial, and appreciate their ongoing participation.?
The Prochymal Crohn?s program consists of two separate but related double blinded trials. The first trial evaluates patients? initial response to two dose levels of Prochymal as compared to placebo. The trial was
originally designed to enroll 270 subjects. 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 response bias to meet the eligibility
requirements for continuation of therapy in the longer-term maintenance trial.
David Meeker, M.D., Executive Vice President at Genzyme Corporation said, ?We fully agree with the decision by Osiris to end enrollment in this trial due to what appears to be a problem with the trial design. We think
this is prudent and will enable a more efficient path forward. The data from this trial will be extremely valuable in designing the subsequent trial and enabling the continued development of this first-in-class
therapy.?

 

[Kaye]

Danny

What exactly did that say? Were the patients not being truthful in order to get the drug in the second phase or was there a carryover effect from the first phase? Did they do a double blind on the patients who were enrolled the first time when they qualified the second time? I'm agree with you, GET ON WITH IT! Dang the FDA anyway.
Kaye

 

[hlichten]

You can not pin this problem on the FDA.

Also, this has nothing to do with patient's honesty during the trial.

Osiris is trying to create trials which can then be peer reviewed (reviewed by other scientists) looking for flaws in their testing methodology.

Since Osiris themselves found a flaw in the methodology, they have to amend the test, since it would (obviously) fail a peer review.

Osiris should be applauded here for catching this in time to save most of their test results as being valid.

Yes, the FDA is crap, and the new administration will work to change it, but it will also take some time.

But, this is not an FDA problem.

However, if the FDA were to release all autologous human marrow-based cells for infusion into any part of the donor's own body, then no tests of this kind would be needed.

But...since Osiris doesn't appear to use autologous cells (cells from the donor themselves) and since Osiris adds "something" to the cells, they would not be included in any such release.