BioWorld International Correspondent
JERUSALEM, Israel - Pharmos Ltd. is not being put off by its stock market evaluation; rather it is forging ahead into untapped therapeutic markets, the most recent being cognitive impairment following coronary surgery.
Patient enrollment in a Phase II study of its lead compound, Dexanabinol, as a preventive agent against cognitive impairment following coronary surgery will be based in Tel Aviv at Sorasky Medical Center following approval by the Israeli Health Authority Helsinki Committee. The plan is to enroll 60 to 200 patients, and other centers may be added later to reach the goal. Enrollment will begin in October.
Pharmos, of Ness-Tziona, Israel, and Iselin, N.J., received approval from the Israel Ministry of Health two weeks ago to begin the trials, the first of a compound that could impact millions of patients worldwide who undergo coronary surgery.
Pharmos CEO and Chairman Haim Aviv told BioWorld International: "The opportunity to prevent cognitive impairment with Dexanabinol in patients undergoing bypass surgery is enormous. This is an important strategic move that significantly broadens our pipeline."
Pharmos Medical Director Seth Kindler described postsurgical MCI as "a serious risk facing patients after major heart surgery. The impairment adds to rehabilitation costs, and postsurgical MCI is a known risk factor for progression to Alzheimer's disease. As many as 50 percent of patients may suffer inability to concentrate, memory loss, a significant slowdown in response time and difficulty in returning to presurgical functioning. The potential market is huge and simply void of any treatment."
Aviv is optimistic that the new application and consistent progress in Dexanabinol trials will impact Pharmos' share price, which has recorded no gains as revenue has not increased since the fourth quarter of 2001 when the firm sold its ophthalmic business, including two marketed products, to Bausch & Lomb.
During 2002's second quarter, net research and development expenses rose 14 percent compared to the respective period in 2001. Nearly $2 million was related to the Pharmos Phase III trial of Dexanabinol for traumatic brain injury, largely to increase the enrollment rate in the U.S., expected to reach 860 patients in 2003.
Aviv said: "Patient enrollment in the European leg of Dexanabinol's Phase III TBI trial continually improved over the last four months, and is now almost 50 percent higher than it was at the end of March. Preparation of the [investigational new drug application] filing to commence enrollment in the U.S. is proceeding smoothly; data have been generated and the final reports should be ready for submission to the FDA by the beginning of the fourth quarter."