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| Int. Pivotal Study Scheduled for This Year |
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Posted by FoM on March 07, 2000 at 10:55:07 PT Press Release Source: PRNewswire 
Pharmos Announces Successful Completion of Phase II Head Trauma Clinical Studies. Pharmos Corporation announced today the successful completion of the third cohort of its phase II escalating-dose clinical trial of dexanabinol for traumatic brain injury (TBI). The phase II goals of establishing the safety of dexanabinol in TBI and the dosing parameters for a pivotal study were met, allowing for the commencement of an international pivotal trial of several hundred patients later this year. "The results confirm previous findings that dexanabinol is safe and prevents the elevation of intracranial pressure (ICP) in severe head trauma patients," said Dr. Nachshon Knoller, Principle Investigator of the study. "The results will enable us to select the optimal dose to be used later this year in a multi-national pivotal clinical study designed to demonstrate the efficacy and to confirm the safety of dexanabinol in a large population of severe head trauma patients," added Dr. Nadim Kassem, Pharmos Vice President, Clinical and Regulatory Affairs. Currently no drug is approved by the FDA to treat TBI, a leading cause of death and disability among young adults in the U.S. and worldwide. Estimates of the potential worldwide market size for such a product exceed $1 billion annually. "The promising data obtained with dexanabinol and its enormous market potential, coupled with our improved financial position are compelling reasons for us to continue along an aggressive development path," said Dr. Haim Aviv, Chairman and CEO of Pharmos. An aggregate of 101 patients were enrolled in the multi-center, double-blind, randomized phase II study, which was carried out in six trauma centers in Israel affiliated with the American Brain Injury Consortium. Fifty-two of the patients were treated with dexanabinol at three separate doses and forty-nine received a placebo. In the third cohort, which was just completed, thirty-three patients received an intravenous injection of either 200 mg. of dexanabinol (N=21) or placebo (N=12) within six hours of injury. Demographically, these patients were fairly representative of the TBI population, comprising mostly young men injured in motor vehicle accidents. However, the dexanabinol and placebo groups differed with respect to several important baseline entry parameters affecting the patients' prognosis; for example, injury severity as determined by the Glasgow Coma Scale was significantly worse in the treated group than in the placebo group. In addition, the patients' CT classifications indicating the extent of the brain injury were worse in the drug-treated group compared to placebo. Predictably, the strong trend for better neurological outcome in comparison with placebo that was observed in the first two cohorts was not repeated in this cohort. Nevertheless, ICP above a threshold of 25mmHg, a major risk factor affecting the prognosis of TBI, was lower 40-70% of the time during the first days after injury in the treated group vs. the placebo group. This result was similar to those of the previous two cohorts (48mg. and 150mg. doses) reported in October 1998. Levels of dexanabinol in the patients' blood demonstrated that fifty percent exceeded the expected therapeutic dose determined from earlier animal trials. In some cases, blood levels exceed the therapeutic dose by more than three times. Based on this result, no further dose escalation is required. Analysis of the results of the three cohorts is ongoing to determine the optimal dosage for the pivotal studies. Dexanabinol (HU-211) is the lead compound in Pharmos' Central Nervous System (CNS) protection R&D platform. The Company is designing, synthesizing, screening and developing analogs of dexanabinol to exploit its distinctive neuroprotective and anti-inflammatory properties. Dexanabinol and other cannabinoid analogs do not bind to cannabinoid receptors in the brain, but maintain many of the positive pharmacological properties of this family of compounds and are potentially efficacious in the treatment of stroke, Parkinson's disease, neuropathic pain, Multiple Sclerosis, Alzheimer's disease, inflammatory bowel disease, rheumatoid arthritis, macular degeneration, glaucoma, and other indications. Pharmos Corporation is a bio-pharmaceutical company that develops and commercializes products for the ophthalmic, central nervous system, neurological and other key healthcare markets. The Company has a diverse product pipeline that includes: marketed products with superior therapeutic indexes, and drug candidates with enhanced molecular structures that display improved safety and/or efficacy properties compared to the parent molecules or to competing products. Statements made in this press release related to the future beneficial expectations of the Company are considered "forward-looking" and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties which may cause results to differ materially from those set forth in these statements. Additional economic, competitive, governmental, technological, marketing and other factors identified in Pharmos' filings with the Securities and ExchangeCommission could affect such results. Dexanabinol: Iselin,, N.J., March 7 PRNewswire CannabisNews Related Articles & Medical Marijuana Archives: Brain Responds To Pain With MJ - Like Substance Israel: Using Pot To Save Brains http://www.cannabisnews.com/news/list/medical.shtml Home Comment Email Register Recent Comments Help |
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| Comment #2 posted by FoM on March 07, 2000 at 12:44:20 PT |
| Comment #1 posted by Freedom on March 07, 2000 at 12:26:12 PT |
Translation: Those ickey cannabinoids that bind to cannabinoid receptors in the brain induce an evil euphoria,
so we must deny the best form of cannabinoid therapy nature has to offer, in favor of a therapy that only provides many of those benefits without that evil undesireable euphoria.
And, we can patent it and makes lots of money, much of it off of poor folk. As for those who cannot afford our pharmeceutical product, let them eat Marinol in jail.
Don't expect us to run trials comparing the relative efficacy of whole cannbis to our single molecule either.
One has to admire to propaganda machinery of the WoDs establishment. They have corrupted the NIDA, the Dept. of Agriculture, the AMA, the Opthalmology Asso., the MS Society, the Heart Asso., etc... I cannot believe the statements from Britain last week from their MS group...
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