FDA Approves Phase I Human Clinical Trials of Polydex AIDs, STD, Contraceptive Drug.TORONTO, Ontario--(BUSINESS WIRE)--May 6, 1999-- Research backed by major public, private institutions The U.S. Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has approved an Investigational New Drug (IND) exemption filed in February by The Consortium for Industrial Collaboration in Contraceptive Research (CICCR) and Polydex Pharmaceuticals Limited (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :POLXF) for Phase I human clinical trials to test the safety and tolerance of Ushercell. A nine-month trial, funded by CICCR, will begin immediately. Patented by Polydex in 1999, Ushercell was developed jointly by scientists at Polydex and the Program for the Topical Prevention of Conception and Disease (TOPCAD), based at Rush-Presbyterian-St. Luke's Medical Center and the University of Illinois University of Illinois may refer to:
Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely (STDs) as well as unplanned pregnancies. According to Dr. Lourens Zaneveld, Director of Obstetrics and Gynecology obstetrics and gynecology Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system. Research at Rush-Presbyterian-St. Luke's Medical Center and leader of the TOPCAD Ushercell research team, pre-IND acute and subacute toxicology test results have already demonstrated that Ushercell is very safe and much less irritating than Nonoxynol-9. Ushercell has shown anti-fertility activity in vitro and in rabbits. In vitro tests also indicate broad antimicrobial activity against sexually transmitted pathogens including HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , gonorrhea, chlamydia and herpes 1 & 2 but not normal, healthy vaginal microflora microflora /mi·cro·flo·ra/ (-flor´ah) the microscopic vegetable organisms of a special region. Microflora The bacterial population in the intestine. . STD (Subscriber Trunk Dialing) Long distance dialing outside of the U.S. that does not require operator intervention. STD prefix codes are required and billing is based on call units, which are a fixed amount of money in the currency of that country. prevention studies in animals are currently in progress. "All our pre-IND tests have indicated that Ushercell holds great promise as a topical prophylactic for sexually transmitted diseases, including AIDS, and as a contraceptive," said Polydex President George G. Usher. "Now, with Phase I human trials underway -- the start of the FDA approval process -- we are getting closer to the successful culmination of this project, which we began in August 1993," he said. Usher noted that upon successful completion of the full FDA testing and approval process, Polydex would hold the exclusive worldwide license for Ushercell, which he expects to market as an STD/AIDS preventative and contraceptive product. Usher estimated that the worldwide market for such products might well be $1 billion per year, according to market research. CICCR, part of the Contraceptive Research and Development Program (CONRAD Conrad, Latin king of Jerusalem Conrad, d. 1192, Latin king of Jerusalem (1192), marquis of Montferrat, a leading figure in the Third Crusade (see Crusades). He saved Tyre from the Saracens and became (1187) its lord. ) of the U.S. Agency for International Development, is designed to help in the development of new contraceptive agents that specifically address the needs and perspectives of women. CONRAD targets developing nations in its product research and development efforts. CICCR commenced operations on October 1, 1995 with funding from the Rockefeller, Andrew W. Mellon, Hewlett and Gates Foundations and the United Nations Population Fund The United Nations Fund for Population Activities (UNFPA) began funding population programs in 1969. It was renamed the United Nations Population Fund in 1987, but kept its original abbreviation. . Polydex Pharmaceuticals Limited researches, develops, manufactures and markets biotechnology based products for veterinary, human pharmaceutical and cosmetics industries worldwide. The company is conducting part of its research through collaborations with the Rush Institute in Chicago, IL on a potential female contraceptive product and the University of British Columbia Locations Vancouver The Vancouver campus is located at Point Grey, a twenty-minute drive from downtown Vancouver. It is near several beaches and has views of the North Shore mountains. The 7. on a potential treatment for cystic fibrosis. Note: This press release may contain forward-looking statements, as defined in the Securities Exchange Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, regarding Polydex Pharmaceuticals Limited. Actual events or results may differ from the Company's expectations, which are subject to a number of known and unknown risks and uncertainties including but not limited to future actions by the Food and Drug Administration or equivalent foreign regulatory authorities as well as results of pending or future clinical trials. Other risk factors listed in the Company's SEC filings may also affect the actual results achieved by the Company. |
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