Pharmos' Traumatic Brain Injury Trial of Dexanabinol Expands into U.K.
ISELIN, N.J., Sept. 19 /PRNewswire/ -- Pharmos Corporation (Nasdaq: PARS and Nasdaq Europe: PHRM) today announced that the U.K. Medicines Control Agency has approved Pharmos' application for a Clinical Trial Exemption (CTX) to expand its pivotal Phase III trial of dexanabinol for traumatic brain injury (TBI) into the U.K. The U.K. is the eighth country to join the study, which currently includes over 30 centers located in Finland, France, Germany, the Netherlands, Italy, Belgium and Israel. The Company expects to obtain approval to commence the study in Spain, the next European country to participate, by the end of the month.
Graham Teasdale, M.D., Chairman of the European Brain Injury Consortium (EBIC) and Professor of Neurosurgery at Southern General Hospital in Glasgow, Scotland, said, ``The commencement of clinical studies of dexanabinol is good news for patients who have had a serious head injury. Despite the best of current intensive supportive efforts, failure to recover fully is still common and there is a need for a drug that will act directly to reduce the amount of damage in the brain. Preliminary results indicate that dexanabinol may fulfill this role and studies in U.K. centers, many of which have extensive experience and an international reputation, should provide decisive information.'' Pharmos is collaborating with EBIC in a number of areas, including recruitment efforts with trauma centers throughout Europe. Up to eight leading centers in the U.K. may participate in the study, including the University Hospital in Nottingham, England.
``Obtaining approval to proceed with our pivotal trial of dexanabinol in the U.K. adds a great deal of momentum to this study by making available several high profile and geographically important centers,'' said Haim Aviv, Ph.D., Chairman & CEO of Pharmos. ``It also marks the near completion of the regulatory processes for the European leg of the study, enabling us to focus more resources on providing the FDA with the information required to extend the study into the U.S., a process in which we are actively engaged.'' Total worldwide enrollment of approximately 860 is expected to be completed in 2003.
Traumatic Brain Injury
Brain damage due to TBI is one of the most common causes of death in developed countries, and results in a wide spectrum of permanent physiological, neurological and psychological disabilities that affect not only the victims, but also their families and communities. The majority of victims are men between the ages of 18 and 34 and motor vehicle accidents lead the list of causes, followed by falls and violence-related incidents. A 1992 report by the Washington D.C. based National Foundation for the Brain, ``The Cost of Disorders of the Brain,'' estimates the total annual cost of TBI to be $48.3 billion in the U.S., with hospitalizations accounting for $31.7 billion, and fatal brain injuries $16.6 billion. Based on the current lack of an approved, effective drug, and the tremendous financial consequences of the indication, Pharmos may apply to the FDA to review its NDA submission under fast-track status. If approved, dexanabinol is expected to be the first TBI product on the market and may generate significant revenues in the over $1 billion annual worldwide market.
Pharmos Corporation discovers and develops novel therapeutics to treat a range of inflammatory and neurological disorders, such as traumatic brain injury and stroke. The Company has an extensive portfolio of drug candidates under development, as well as discovery, preclinical and clinical capabilities. |
