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DewDiligence

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Re: drbio45 post# 38878

Thursday, 01/04/2007 6:41:17 AM

Thursday, January 04, 2007 6:41:17 AM

Post# of 252279
D-Pharm Announces Positive Phase-2b Results in Acute Stroke

[These results are mixed rather than clearly positive. Negative: the primary endpoint—change in the NIHSS score from day 0 to day 90—was missed for the intent-to-treat group and the PR attempts the usual subgroup spin. Positive: the secondary endpoint of “complete recovery” was hit. Interestingly, patients treated 6-9 hours after stroke onset did as well as those treated <6 hours from stroke onset. One possible explanation for this (which isn’t broached in the PR) is that most patients were treated close to six hours from stroke onset and hence the distinction between the <6 hr subgroup and the 6-9 hr subgroup may be not be all that consequential.]

http://biz.yahoo.com/prnews/070103/ukw003.html?.v=95

>>
Two-Fold Increase in Number of Patients Achieving Complete Recovery
Wide Therapeutic Treatment Window Confirmed

REHOVOT, Israel, January 3 /PRNewswire/ -- D-Pharm announced today successful completion of the Phase IIb trial for its neuroprotective compound DP-b99 in the treatment of acute ischemic stroke patients. DP-b99 is a unique neuroprotective drug that addresses an array of damaging processes occurring in the brains of stroke patients.

A significantly higher recovery rate after stroke was found in the DP-b99 treatment group compared to the placebo group. The study also confirmed the excellent safety and tolerability profile of DP-b99. There was no difference in response to DP-b99 treatment between those patients treated within six hours or within six to nine hours following stroke onset confirming the wide therapeutic treatment window for DP-b99.

The double blind, placebo controlled, multi-center trial enrolled 150 patients with ischemic stroke with a baseline NIH Stroke Scale (NIHSS) score of 7 to 20. Patients were recruited in 27 centers in Germany, Israel and South Africa. DP-b99 was administered intravenously, up to 9 hours following stroke onset. The patient group in the study was stratified into those treated within six hours or within six to nine hours following stroke onset.

Efficacy

The efficacy of the treatment was primarily evaluated using the change in NIHSS, a measure of neurological improvement, from baseline to day 90, and the rate of complete recovery according to the Modified Rankin scale, a measure of global disability, and NIHSS (score of 0 or 1 on day 90 after stroke on either scale).

The change in NIHSS [the primary endpoint], from day 0 to day 90 was found to be significantly higher in the DP-b99 treatment group with moderate to severe stroke at baseline (NIHSS 10-16) [the subgroup spin]. When all patients were analyzed together [an awkward way of describing the intent-to-treat group], the change of NIHSS was apparent but did not reach statistical significance.

There was a significant two-fold increase in the number of patients achieving complete recovery from stroke (Modified Rankin scale) in the DP-b99 treated group compared to placebo (p=0.05). A similar result was also found concerning recovery as judged by the NIHSS. [“Complete recovery” is a secondary endpoint.] When recovery includes either the Rankin or NIHSS definition, the significance of this result is even greater (p=0.02).

There was no difference in response to DP-b99 treatment between those patients treated within six hours or within six to nine hours following stroke onset.

Dr Alex Kozak, D-Pharm's CEO and President, said: "The Phase IIb results are really impressive and a great achievement. These results show DP-b99's winning combination of excellent safety, robust efficacy and wide therapeutic window. DP-b99 doubles the chances of patients with stroke to completely recover. We are now entering into strategic discussions to find the optimal path through late stage global clinical development towards marketing approvals."

Dr Gilad Rosenberg, VP Clinical Development at D-Pharm added: "We are very encouraged by the fact that this is the second Phase II clinical study in which we observe beneficial effects of DP-b99 on ischemic stroke outcomes. It is very important also that we've managed to define the stroke population in which DP-b99 is beneficial, which will help us immensely in the future."

Safety

Results from this trial confirm the excellent safety and tolerability profile of DP-b99. An independent Drug Safety Monitoring Board (DSMB) met regularly throughout the trial to review the safety data and found no significant differences in the number of serious adverse events, death cases or death causes between the DP-b99 and placebo groups. The safety profile in the current study is in line with D-Pharm's previous clinical experience from the Phase I and IIa studies.

In addition to confirming safety and efficacy, this study has better defined the optimal patient population and therapeutic window for DP-b99. D-Pharm anticipates releasing additional, more detailed data from this study through scientific meetings and journals.

Ruben Krupik, Chairman of D-Pharm's Board of Directors and CEO of Clal Biotechnology Industries said: "Success in this Phase IIb trial, in such a difficult therapeutic area, is an important milestone both for the company as well as for the industry as a whole. The achievement results from the quality of D-Pharm's unique technology and the excellence of the D-Pharm team. D-Pharm will continue to enjoy the full support of the Board and its Investors."

About Stroke

Stroke is the leading cause of neurological disability worldwide and reflects a considerable unmet need in effective acute stroke therapy, which DP-b99 aims to address. Projected costs to the United States of ischemic stroke and its aftermath add up to an enormous $2.2 trillion. With no drug that protects the brain in stroke yet approved, the medical and economic need for an effective treatment is enormous. Projected world wide sales for an effective acute stroke therapy are expected to greatly exceed $1B.

DP-b99

DP-b99 is a new chemical entity that emerged from D-Pharm's proprietary platform technology Membrane Active Chelators (MAC). DP-b99 is a first in class neuroprotective compound, membrane activated lipophilic chelator of zinc, copper and calcium ions.

DP-b99 binds excessive metal ions within cell membranes and thus modulates multiple metal-dependant processes associated with cell damage and death of brain cells in stroke.

Considerable evidence suggests that redistribution of metal ions and disturbances in metal ion homeostasis are key components in the cascade of events underlying cell damage in stroke. In the first hours post-stroke, ion disturbances cause excitatory cell damage and in the days and weeks following they contribute to edema, inflammation and cell death. D-Pharm's novel approach to neuroprotection is based on selective modulation of calcium, zinc, copper and iron homeostasis in the vicinity of cell membranes. Outside the lipid environment of cell membranes DP-b99 adopts an inactive conformation and is unable to bind metal ions at their physiological concentrations which result in a drug with excellent tolerability.

In earlier Phase I and II clinical trials DP-b99 was proven to be safe both in healthy young and elderly volunteers and in stroke patients. Efficacy evaluation in Phase IIa demonstrated noteworthy improvements in clinical stroke outcome assessed with the NIH Stroke Scale (NIHSS) 2, 7 and 30 days after stroke in patients treated with DP-b99 within 12 hours of the onset of stroke symptoms.

About D-Pharm Ltd.

D-Pharm (www.dpharm.com) is a biopharmaceutical company pioneering the development of lipid-like therapeutics and has generated a rich product pipeline from its drug targeting and discovery technologies, Regulated Activation of Prodrugs (D-RAPTM) and Membrane Active Chelators (MAC). The company is considering its strategic options regarding the continued global development of DP-b99.

D-Pharm's pipeline includes DP-VPA, a new chemical entity that is a modified and targeted version of valproic acid for epilepsy, bipolar disorder treatment and migraine prophylaxis. DP-VPA is currently in an advanced stage of a clinical Phase II program. In preclinical development is DP-460, an oral, disease-modifying therapy for Alzheimer's disease. For further information visit our web site: www.dpharm.com.
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