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Harvard Scientific to Introduce New Drug for Treatment of Female Sexual Dysfunction.


RENO, Nev.--(BW HealthWire)--May 1, 1998--Harvard Scientific Corp., (OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
 BB:HVSF) a Nevada corporation announced today that it will soon unveil its new proprietary treatment for female sexual dysfunction sexual dysfunction

Inability to experience arousal or achieve sexual satisfaction under ordinary circumstances, as a result of psychological or physiological problems.
 which utilizes the company's patented formula of lyophilized ly·oph·i·lize  
tr.v. ly·oph·i·lized, ly·oph·i·liz·ing, ly·oph·i·liz·es
To freeze-dry (blood plasma or other biological substances).



[lyophil(ic) + -ize.
 liposomal Prostaglandin E-1 ("LLPGE1").

Toxicity studies are being planned at this time and the company anticipates these to begin shortly. The company believes that a sizable market already exists as evidenced by the recent euphoria over Pfizer's (NYSE NYSE

See: New York Stock Exchange
:PFE 1. (text, editor) PFE - Programmer's File Editor.
2. (language) PFE - Portable Forth Environment.
) intentions to test its pill on women in Europe and that this market is likely to expand rapidly as effective therapeutic drugs are introduced for this disorder.

According to Dr. Irwin Goldstein, a Boston University urologist, "Approximately 10 million women in the United States between the ages of 50 and 74 reported a lack of lubrication lubrication, introduction of a substance between the contact surfaces of moving parts to reduce friction and to dissipate heat. A lubricant may be oil, grease, graphite, or any substance—gas, liquid, semisolid, or solid—that permits free action of  on 229 million sexual intercourse occasions." On April 4, 1998, Gina Kolata reported in the New York Times that by "defining sexual dysfunction as discomfort during sexual intercourse, dryness, increased time for arousal, diminished ability to reach orgasm, or diminished clitoral clitoral

pertaining to or emanating from the clitoris.


clitoral hypertrophy
may occur in Cushing's syndrome as a result of increased androgens produced by a hyperplastic or neoplastic adrenal cortex.
 sensation," Dr. Goldstein found that 58.5 percent of the 260 female partners of impotent men he surveyed were affected. "And, as like men, the women were more likely to have sexual difficulties if they were older and if they had medical conditions relating to vascular problems."

The company believes that a vasodilator vasodilator /vaso·di·la·tor/ (-di-la´ter)
1. causing dilatation of blood vessels.

2. a nerve or agent that does this.


va·so·di·la·tor
n.
 such as its LLPGE1 erectile dysfunction treatment Erectile Dysfunction Treatment Definition

Drugs and devices that treat erectile dysfunction (ED), the inability to achieve or maintain an erection long enough to engage in sexual intercourse.
 product will provide a solution to this problem by stimulating the production of vaginal fluid and increasing blood flow to the area, thus providing suitable lubrication for sexual intercourse as well as heightened sensation.

Dr. Darryl See stated: "A woman's inability to become properly stimulated during sexual activity can result in anorgasmia anorgasmia /an·or·gas·mia/ (an?or-gaz´me-ah) inability or failure to experience orgasm.anorgas´mic  (the inability to achieve orgasm) which leads to frustration as well as a genuine lack of desire on her part for sexual intercourse. The same type of tissue makes up both male and female sex organs and it is the company's belief that its treatment product will enhance stimulation and sensitivity in the female sex organs, thus enabling greater satisfaction and possibly sexual orgasm."

Both Dr. Goldstein and Dr. See are consultants to the company. The company has appointed Dr. Goldstein as its lead clinical investigator for its male erectile dysfunction Phase II clinical trials which will begin upon approval by the U.S. 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.
. Dr. See is also the Project Manager for the company.

Harvard Scientific Corp. is a biopharmaceutical company that develops products relating to liposomal delivery of Prostaglandin E-1 for the treatment of impotency as well as male and female sexual dysfunction. The company's patented process allows the Prostaglandin E-1 to be administered as a liquid via a painless delivery system. The company also has developed a topically applied skin treatment for psoriasis and is working with the FDA to establish Phase I clinical trials protocol for that product.

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 Upjohn's Caverject(R), which is administered by needle injection as a treatment for male erectile dysfunction. In November 1996, Vivus Inc.'s MUSE(R) delivery system was approved by the FDA. The company believes that its product represents 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: I.W. Miller & Co.

Ira Miller, 714/833-9001

or

Martin E. Janis & Co.

Hal Schweig, 312/943-1100

or

Harvard Scientific Corp.

Michael Snell, 407/324-1606

www.virtualir.com/hvsf
COPYRIGHT 1998 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1998, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:May 1, 1998
Words:655
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