Biotech Values

[drbio45]

Desmoteplase study back

http://biz.yahoo.com/prnews/061027/nyf113.html?.v=5

Patient Recruitment to Resume Without Modification of Protocol for Desmoteplase Phase IIB/III Stroke Study DIAS-2
Friday October 27, 11:08 pm ET [!]

NEW YORK, Oct. 27 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX - News) and its development partner for desmoteplase, PAION AG (Aachen, Germany), today announced that the independent Data Monitoring Committee (DMC) for the DIAS-2 Phase IIB/III study met and informed the Steering Committee and the Companies that it has reviewed the cumulative data from the study provided by the Companies and recommended the resumption of patient enrollment into DIAS-2 with no modification of the protocol. At this meeting, the DMC reviewed data from 170 randomized subjects. The DIAS-2 study is evaluating PAION's drug candidate desmoteplase in patients with acute ischemic stroke. The Companies continue to expect that enrolment will be completed by the end of 2006 and that study results will be available by the middle of 2007.

from the above press release it they were able to make the determination that the trial should be continued without breaking the blind.

Unlike the failure of Cerovive which would have added billions of dollars of increased healthcare costs if they would have reached statistical significance in a clinically meaningless benefit and failure of the drug was not a tragedy, the failure of desmoteplase which has the potential to increase the quality of life of millions of future stroke patients and end up reducing healthcare costs because rehabilitation from stoke adds billions of dollars to the cost of healthcare and early reperfusion can reduce the cost of rehabilitation, desmoteplase failure would have been a tragedy.

It is my belief that desmoteplase, if the trial is successful, will change the treatment paradigm for stroke.

All this for a market cap under 200 million dollars

They have reviewed that data for 170 randamized patients. The trial will probably be completely enrolled withing 2 weeks. I hope they add at least 18 to 24 patients. Nothing wrong with having a little more safety data, if possible skip the 90 ug dose and just add more patients to the 125 ug dose if they can do it without delaying the trial by getting feedback from the FDA.