Friday January 30, 10:15 am Eastern Time
Company Press Release
Harvard Scientific's Sterilization Study Proves New Cost Saving
Process for GMP Product
RENO, Nev.--(BW HealthWire)--Jan. 30, 1998--Harvard Scientific Corp. (OTC BB:HVSF - news), a
Nevada corporation, announced Friday that a study utilizing gamma radiation instead of standard
.2 micron filters to sterilize the chemical components in its patented lyophilized liposomal
PGE-1 formulation process, has proven totally successful in the production of ''GMP'' (Good
Manufacturing Practice) product.
Gamma radiation will cost less than ten percent of the normal cost associated with
sterilization by standard micron filtration and will be used exclusively by the company due to
this beneficial cost savings. The collaborative efforts of Sterigenics Inc. in Corona, Calif.
and Pyramid Labs is Costa Mesa, Calif. assisted the company in completing this study.
Dr. Darryl See, project manager and consultant to the company, stated: ''GMP products are both
sterile and clinically stable and are therefore, suitable for clinical trials and use by the
general public, according to FDA standards. The results of this study confirm that gamma
radiation does not cause any degradation at all to the active PGE-1 or to any other chemical
components used in the company's patented lyophilized liposomal treatment products. However,
many other companies that use this less expensive form of sterilization for their products
experience a breakdown of the chemical's composition, rendering those chemicals inactive and
unsuitable for use in treatment processes. This provides the company another significant
advantage over its potential competitors. The company now has a sufficient supply of GMP
product in storage, awaiting FDA approval to proceed with Phase II clinical trials.''
Harvard Scientific Corp. is a biopharmaceutical company that develops products relating to
liposomal delivery of Prostaglandin E-1 for the treatment of male erectile dysfunction,
impotency and sexual enhancement. 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. FDA for
intravenous infusion in neonates. In 1995, PGE-1 was approved by the FDA as a treatment for
male erectile dysfunction for Upjohn's Caverject(r), which is administered by needle injection.
In November 1996, Vivus Inc [Nasdaq:VVUS - news].'s MUSE(r) delivery system was approved by the
FDA. The company believes that its product represents a tremendous 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 |
