Replies to post #21886 on Biotech Values

[terry hallinan]

io_io - DSCO,

Discovery Labs Announces Encouraging Preliminary Data from ARDS Phase 2 Clinical Trial

Expands Trial to Strengthen Endpoint Signal Prior to Designing Potential Phase 3 Trial

WARRINGTON, Pa., Dec. 7, 2004 (PRIMEZONE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), announced encouraging preliminary data from its Surfaxin(r) Phase 2 clinical trial for the treatment of Acute Respiratory Distress Syndrome (ARDS) in adults. Discovery will hold a conference call today at 11:00 AM EST. The call in number is 800-665-0669.

The ARDS Phase 2 trial is comprised of two parts; a dose-escalation/safety phase and an efficacy/safety phase. As of November 15, 2004, a total of 89 patients were enrolled in the trial and completed the 28-day study. The table below shows results from 78 evaluable patients. These evaluable patients received either one of two dosing regimens chosen for the efficacy/safety phase, or Standard of Care.

----------------------------------------------------------------
Relative
Difference in
Favor of
Group B vs.
Surfaxin Dose Surfaxin Dose Standard of Standard of
Endpoint Group A (1) Group B (2) Care Group Care
------------- ------------- --------- ------
(N=29) (N=29) (N=20)
----------------------------------------------------------------
All cause
Mortality
@ Day 28 13.8% 13.8% 20.0% 31.0%
----------------------------------------------------------------
Incidence of
being Alive
& off MV @
Day 28 69.0% 82.8% 75.0% 10.4%
----------------------------------------------------------------
(1) Dose Group A: Two Surfaxin lavages totaling up to 57,000 mg of
phospholipid
(2) Dose Group B: Two Surfaxin lavages and boluses totaling up to
61,000 mg phospholipid

Both Surfaxin dose groups showed a 31% relative improvement in overall mortality assessed at Day 28 versus Standard of Care. With respect to the primary endpoint of the incidence rate of being alive and off mechanical ventilation at Day 28, 69% of Dose Group A patients, 82.8% of Dose Group B patients, and 75% of the Standard of Care patients, were alive and off mechanical ventilation. With respect to overall safety, no differences were apparent between the two Surfaxin treatment groups.

Antonio Anzueto, M.D., Professor of Medicine at the University of Texas Health Science Center at San Antonio, commented, "Following my review of the preliminary data, I am impressed with these observations..."...

http://www.primezone.com/newsroom/news_releases.mhtml?d=68940

I am always impressed when a fellow like Dr. Anqueto is impressed. :-)

You might notice that the Group A Surfaxin arm showed up worse than standard of care in the category "Incidence of being Alive & off MV @ Day 28." That was explained by survival of some that might have died but remained on mechanical ventilation past day 28.

I would make a wild guess DSCO did some heavy thinking about endpoints. :-)

In any case the trial did not produce statistically significant results, despite impressing Dr. Anqueto. Just gave a hint of what might come. May have helped establish the most likely profiling of patients to be successful. ARDS presents such a vast array of differences in cause that you could be think of a classification like "Accidental Injury To Lungs." It would seem to me to make any forecast especially hazardous.

Best, Terry