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Rehovot High Tech: D-Pharm Announces the Recommendation of an Independent Board to Continue drug Study in Acute Stroke Patients
"REHOVOT, Israel (8 November 2005) D-Pharm announced today encouraging interim results from the ongoing Phase II study of its neuroprotective agent DP-b99 in acute stroke patients. DP-b99 is a unique neuroprotective drug that addresses the array of damaging processes occurring in the brains of stroke patients.
The Safety Monitoring Board, which includes experts in neurology, cardiology and clinical pharmacology, reviewed the safety data of the first 62 subjects enrolled into the study, and has recommended the study continue in its present design.
"Careful safety monitoring is of vital importance in the development of new stroke medications. The decision of the Board is an encouraging step in the advancement of this study" said Dr Gilad Rosenberg, D-Pharm's VP, Research and Clinical Development.
The interim analysis trial data was blinded and the patients were split into groups A or B without disclosure of active drug or placebo designation. Thirty-one subjects were in each group. Both groups were comparable for most baseline characteristics, including gender, age, body mass index and mean NIH Stroke Scale score. The Board evaluated clinical, laboratory and electrocardiographic data. The rate, nature and distribution of adverse events were similar in both groups.
This favorable judgment confirms the results of D-Pharm's previous DP-b99 Phase IIa study in stroke, in which the safety profile of DP-b99 did not significantly differ from that of placebo.
Alex Kozak, Chief Executive of D-Pharm, said: "In the last two decades a very high proportion of failures in stroke trials have been due to safety issues. Our goal is to develop an effective drug to protect brain cells after stroke that causes no further harm to patients. With today's decision, DP-b99 has passed an important juncture of its clinical development."
The current Phase II study aims to recruit 150 acute stroke patients in more than 20 centers in Germany and Israel. The study results are expected to be available in the summer of 2006.
DP-b99 is administered intravenously over 4 days with the first administration up to 9 hours following stroke onset. The patient group is stratified into those treated within six hours and within nine hours following stroke onset. D-Pharm expects this study to clearly define the optimal therapeutic window for DP-b99.
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.
DP-b99
DP-b99 is a discovery product, rationally designed using D-Pharm's proprietary technology, Membrane Active Chelators (MAC). 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 is developing a novel approach to neuroprotection based on selective modulation of calcium, zinc, copper and iron homeostasis in the vicinity of cell membranes.
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). These technologies control drug activity via built-in 'switch-on/switch-off' mechanisms. Currently, the company's business strategy is to continue to develop DP-b99 through to completion of Phase II. In addition to DP-b99 D-Pharm's pipeline includes DP-VPA, a new chemical entity that is a targeted modification 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-109, an oral, disease-modifying therapy for Alzheimer's disease. DP-109 has demonstrated impressive efficacy in a transgenic mice model of Alzheimer's disease. At an earlier developmental stage is DP-388 for pancreatic cancer. D-Pharm is currently seeking development partners for DP-VPA and its other pipeline products. For further information visit our web site: www.dpharm.com
For further information please contact: Mary Clark, Capital MS&L, mary.clark@capitalmsl.com ; Andrea Klainer, Corporate Secretary, D-Pharm Ltd. (972-8) 938-5100, fax: (972-8) 930-0795, aklainer@dpharm.com ; Tami Horovitz, PhD. (972-8) 938-5100, tami@dpharm.com .
Source: D-Pharm Announces the Recommendation of an Independent Safety Monitoring Board to Continue the Phase II Study of DP-b99 in Acute Stroke Patients. PRNewswire (8 November 2005) [FullText]
The Safety Monitoring Board, which includes experts in neurology, cardiology and clinical pharmacology, reviewed the safety data of the first 62 subjects enrolled into the study, and has recommended the study continue in its present design.
"Careful safety monitoring is of vital importance in the development of new stroke medications. The decision of the Board is an encouraging step in the advancement of this study" said Dr Gilad Rosenberg, D-Pharm's VP, Research and Clinical Development.
The interim analysis trial data was blinded and the patients were split into groups A or B without disclosure of active drug or placebo designation. Thirty-one subjects were in each group. Both groups were comparable for most baseline characteristics, including gender, age, body mass index and mean NIH Stroke Scale score. The Board evaluated clinical, laboratory and electrocardiographic data. The rate, nature and distribution of adverse events were similar in both groups.
This favorable judgment confirms the results of D-Pharm's previous DP-b99 Phase IIa study in stroke, in which the safety profile of DP-b99 did not significantly differ from that of placebo.
Alex Kozak, Chief Executive of D-Pharm, said: "In the last two decades a very high proportion of failures in stroke trials have been due to safety issues. Our goal is to develop an effective drug to protect brain cells after stroke that causes no further harm to patients. With today's decision, DP-b99 has passed an important juncture of its clinical development."
The current Phase II study aims to recruit 150 acute stroke patients in more than 20 centers in Germany and Israel. The study results are expected to be available in the summer of 2006.
DP-b99 is administered intravenously over 4 days with the first administration up to 9 hours following stroke onset. The patient group is stratified into those treated within six hours and within nine hours following stroke onset. D-Pharm expects this study to clearly define the optimal therapeutic window for DP-b99.
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.
DP-b99
DP-b99 is a discovery product, rationally designed using D-Pharm's proprietary technology, Membrane Active Chelators (MAC). 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 is developing a novel approach to neuroprotection based on selective modulation of calcium, zinc, copper and iron homeostasis in the vicinity of cell membranes.
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). These technologies control drug activity via built-in 'switch-on/switch-off' mechanisms. Currently, the company's business strategy is to continue to develop DP-b99 through to completion of Phase II. In addition to DP-b99 D-Pharm's pipeline includes DP-VPA, a new chemical entity that is a targeted modification 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-109, an oral, disease-modifying therapy for Alzheimer's disease. DP-109 has demonstrated impressive efficacy in a transgenic mice model of Alzheimer's disease. At an earlier developmental stage is DP-388 for pancreatic cancer. D-Pharm is currently seeking development partners for DP-VPA and its other pipeline products. For further information visit our web site: www.dpharm.com
For further information please contact: Mary Clark, Capital MS&L, mary.clark@capitalmsl.com ; Andrea Klainer, Corporate Secretary, D-Pharm Ltd. (972-8) 938-5100, fax: (972-8) 930-0795, aklainer@dpharm.com ; Tami Horovitz, PhD. (972-8) 938-5100, tami@dpharm.com .
Source: D-Pharm Announces the Recommendation of an Independent Safety Monitoring Board to Continue the Phase II Study of DP-b99 in Acute Stroke Patients. PRNewswire (8 November 2005) [FullText]
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