Harvard Scientific's MRI Study Results Indicate Success
Business Wire - October 13, 1998 10:40
LAKE MARY, Fla.--(BUSINESS WIRE)--Oct. 13, 1998--Harvard Scientific Corp., (OTC BB:HVSF) a Nevada corporation, announced today that results of its magnetic resonance imaging ("MRI") studies conducted on female rabbits showed an increase of 45.9% in vaginal capillary blood flow from using the Company's patented lyophilized, liposomal Prostaglandin E-1 ("LLPGE1") in a gel base at a dose of 0.25 mg.
The Company believes these results represents a tremendous breakthrough for the topical product its developing to treat Female Sexual Arousal Disorder ("FSAD"). Past studies (independently conducted) have shown that decreased vaginal blood flow is an important cause for FSAD, which is estimated to affect over 10-million women in the U.S.
Irwin Goldstein, M.D., stated "Harvard Scientific's MRI results strongly suggest that its topical LLPGE1 product may be an outstanding therapeutic advancement in the treatment of FSAD." Dr. Goldstein will be presenting data from the MRI studies at a conference entitled "New Perspectives in the Management of Female Sexual Dysfunction". The conference will be held October 23-25, 1998, in Burlington, Massachusetts.
Dr. Goldstein is a Professor of Urology at Boston University School of Medicine, and a world-recognized pioneer, researcher and authority on sexual dysfunction in males and females. He has been retained by Harvard Scientific Corp. as its Principal Investigator in trials involving the use of the Company's patented LLPGE1 for the treatment of both male and female sexual dysfunction.
Darryl M. See, M.D., the Company's Director of Clinical Affairs stated, "the results from these studies supports our belief that we can provide an effective topical treatment of LLPGE1 for Female Sexual Arousal Disorder administered at a low dose of 0.25 mg. which substantially enhances vaginal capillary blood flow. The results from additional studies (conducted by the Company's scientific team) using doses as high as 2.0 mg. of LLPGE1 further increased blood flow, but not significantly greater than the 0.25 mg. Thus, using a natural product (LLPGE1) at a dose without systemic absorption was tremendously effective in stimulating the desired results without the potential for systemic side effects and will potentially be less costly to provide, thereby providing an added benefit." The Company intends to submit its application for IND for its FSAD topical treatment product to the U.S. Food and Drug Administration this week and anticipates beginning clinical trials in November, 1998.
Harvard Scientific Corp., is a biopharmaceutical drug development company that is developing oral and topically administered treatment products for male and female sexual disorder and an intraurethrally administered treatment product for male sexual disorder. The intraurethrally delivered treatment product as well as the topically applied treatment products utilize the Company's patented intellectual property of lyophilized liposomal delivery of Prostaglandin E-1 ("PGE-1"). The lyophilized liposomal delivery of Apomorphine treatment product for male and female sexual disorder is administered orally as a capsule to the patient. This capsule is designed to pass through the stomach without degradation or uptake of the drug and into the small intestine whereby the Apomorphine is then gradually released. The Company plans to license these products to pharmaceutical companies for worldwide distribution upon approval by the U.S. Food and Drug Administration and/or other foreign regulatory agencies.
Prostaglandin E-1 is a naturally occurring vasodilator originally approved by the U.S. Food and Drug Administration for intravenous infusion in neonates. In 1995, PGE-1 was approved by the FDA for use in Pharmacia & Upjohn Inc.'s (NYSE:PNU) Caverject, which is administered by needle injection as a treatment for male erectile disorder. In November 1996, Vivus, Inc.'s (NASDAQ:VVUS) MUSE solid pellet delivery system was approved by the FDA. Recently, the FDA approved PGE-1 again by needle administration via Edex, (Schwartz-Pharma). Viagra, Pfizer, Inc.'s (NYSE:PFE) oral medication treatment was approved by the FDA in March, 1998. Zonagen Inc. (NASDAQ:ZONA) has in development an oral treatment product as well. Apomorphine has been effective as a therapeutic agent for Parkinson's disease and as a treatment for animal and human ingestion of toxins. It has also shown to be an effective agent for inducing male erections. The Company believes that its products will represent a substantial treatment advantage over other delivery systems currently being utilized in the industry.
From time to time the Company may issue forward looking statements which involve risks and uncertainties. This statement may contain forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Actual results could differ and any forward looking statements should be considered accordingly.
CONTACT: Martin E. Janis & Co.
Hal Schweig, 312/943-1100
www.harvardscientific.com
or
Harvard Scientific Corp.
Michael Snell, 407/324-1606
Headlines Next Story
|
