| CLINICAL STUDY |
CONRAD'S DEVELOPMENT PLAN FOR DRUG MOVES FORWARD IN CLINICAL TRIALS Co. Outsources the Production of 2.5 Million Doses of AIDS Contraceptive Gel Co. reported today that it has received an updated Development Plan from its' collaborative research partner, CONRAD, and provides the following overview of current and planned development of Drug. CONRAD, with funding from various private and public sector donors, has been successful in obtaining further development collaboration from Family Health International (FHI), World Health Organization (WHO) Centers for Disease Control (CDC), and HPTN (HIV Prevention Trials Network). Co.'s Pres. is pleased with the continued progress in the development of drug. "Considering that it usually takes about $500 million dollars and twelve to fifteen years to advance a product from primary studies to FDA approval, we are very pleased that drug has garnered such great support from the research community and their philanthropic supporters. We could not have come this far without them. Drug, now ten years in the making, is preparing to enter late stage clinical trials." Drug is the Company's leading human pharmaceutical compound, a high molecular weight cellulose sulfate envisioned for topical vaginal use primarily in the prevention of transmission of AIDS and other sexually transmitted diseases, as well as unplanned pregnancies. Studies to assess efficacy in contraception and prevention of HIV and other STD's, are scheduled to begin in late 2003, and will require approximately 2.5 million doses of developed compd. Drug continues to show positive results in ongoing Phase I/II safety, tolerance and acceptability studies, in various domestic and international clinical sites. In the recent Development Plan provided to Co. by CONRAD, four additional phase I/II clinical trials are reported as being underway in Uganda, Nigeria, India, Cameroon and the United States. The final analysis is currently underway from a further completed trial conducted in the United States, and additional Phase I/II trials are being planned for sites in Belgium and the United States. Highlights of certain clinical studies included in CONRAD's Development Plan are as follows: A clinical study of 48 sexually active women conducted in collaboration with FHI in Cameroon, has been completed. The final report is expected in 2003. A study in which MRI was used to document the spreading of Drug and the impact of volume, ambulation, and parity on spreading is completed and in analysis, with a final report expected in 2003. In a study underway in collaboration with WHO, participant participation has been completed in Uganda and Nigeria and is ongoing India. The final analysis of this study, which enrolled 180 healthy women, is expected in 2003. Recruitment has begun for a study being carried out in collaboration with HPTN, to establish the safety of and tolerance of Drug among HIV-infected women prior to entering into clinical trials designed to assess HIV prevention. This study will involve 96 women and up to 48 male partners in four sites in the United States and participation is expected to be complete in 2003. A study at two sites in the U.S. and one in the Dominican Republic is underway. The study will assess the safety of twice daily use of Drug by 60 women, half of whom engage in intercourse during the study. The study is expected to be completed in 2003. A tolerance study of 42 HIV-infected men is being planned in collaboration with the Institute of Tropical Medicine, in Belgium, to begin in 2003. A study is planned in collaboration with the University of California at San Francisco to be conducted in 180 sexually active women in Zimbabwe. It will assess the safety and acceptability of Drug used with a diaphragm, and should begin in 2004. Clinical trials demonstrating contraceptive activity of Drug are planned for various sites in the United States and abroad to begin in 2003. Several hundred participants at risk for pregnancy are expected to use Drug for periods of 6 months and 12 months respectively. In collaboration with FHI, clinical trials to assess the effect of Drug on vaginal HIV acquisition in sexually active women at high risk of HIV are to begin in 2004. This study expects to enroll more than 2,000 women |
| UPDATE | 24.06.03 |
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