DRUG STUFF
Their lead drug is DHEA (already available over the counter and by mail order). They have a license from Prendergrast for a proprietary formulation of DHEA with special properties (this sounds familiar to anybody following ZONA). I could not find any mention of a patent.
The following is from the S4/A filed 2/97. Not sure what has transpired in the intervening year.
Hollis-Eden's development efforts are centered around four proprietary
products (the "Products") developed by and licensed from Patrick T.
Prendergast, Ph.D., and are based upon his research in the area of viral-
caused disorders and therapies. Hollis-Eden is the beneficiary of more than
10 years of extensive research and development with respect to the Products
undertaken by Dr. Prendergast and his affiliates prior to the license of
the Products to Hollis-Eden. Hollis-Eden is currently pursuing approval of
two of the Products, INACTIVIN and REVERSIONEX, with the United States Food
and Drug Administration
Hollis-Eden's principal development efforts are currently centered
around two of four new Products licensed by Hollis-Eden which Hollis-Eden
management believes show promise for the treatment and prevention of
HIV/AIDS. Neither INACTIVIN nor any other of the Products has been approved
for commercial sale and no assurance can be given that approvals will be
obtained. Hollis-Eden's current primary focus is on INACTIVIN, which has a
current and open Investigational New Drug (IND) file open with the FDA and
which has completed Phase I of its approval process. While limited
clinical trials of INACTIVIN have to date produced favorable results,
significant additional trials are required, and no assurance can be given
that the drug will ultimately be demonstrated to be safe or efficacious.
Hollis-Eden has never commercially introduced a product, and no assurance
can be given that commercialization of any of the Products in any country
in which any of them may be approved will be financially successful.
INACTIVIN: ANTI-VIRAL FORMULATION OF DEHYDROEPIANDROSTERONE
(DHEA)
Background. In 1987, Colthurst Limited ("Colthurst")
originally licensed DHEA to Elan Pharmaceutical Ltd. ("Elan").
Elan obtained a clinical Investigational New Drug ("IND") with
the FDA and conducted a Phase I escalation study. The results of
this study showed no toxicity and found that patients tolerated
the drug with no side effects. However, Elan chose to use its own
formulation of DHEA instead of the pharmaceutical preparation
advanced by Dr. Prendergast. Subsequently, this Phase I study did
not demonstrate clinical efficacy. In 1992, Colthurst and Elan
ended their five-year agreement. Colthurst continued work on
refining DHEA's pharmaceutical formulation and relicensed the
drug in 1994 to Hollis-Eden. Dr. Prendergast discovered that his
formulation of DHEA (INACTIVIN) was critical to the drug's
ability to penetrate into the cytoplasm of the cell to show its
antiviral effectiveness. As described more fully below, the human
clinical pilot study conducted in 1995 in Houston, Texas
demonstrated that INACTIVIN monotherapy clinically and
statistically significantly reduces viral load in plasma of HIV-1
infected patients with CD4 counts between 50 and 300 cells/mm.
REVERSIONEX: ALPHA-FETOPROTEIN IMMUNOGLOBULIN (AFP)
AFP is a protein synthesized by the liver. During pregnancy,
the function of AFP in the fetus is to suppress the immunological
response of the mother and thereby protect the fetus from
rejection by the maternal immune system.
Research Studies. The observation that initially brought Dr.
Prendergast to consider antibodies to AFP as an anti-viral and
up-regulator of the immune system was AFP's ability to bind to
substrate acid similar to specific HIV coat glycoproteins. This
work was confirmed in 1990 by Professor Agrege Nunez in Paris.
Following this confirmation, Dr. Prendergast tested anti-serum to
human AFP, which showed significant inhibition of HIV in tissue
culture against three standard strains of HIV in T-cell culture
and against HIV in macrophage cells. These results in tissue
culture demonstrated no toxicity.
FDA Status-taken from the same 2/97 document
INACTIVIN
With the results from two small trials under the Phase I/II
IND with crystalline DHEA in AIDS patients completed in Amsterdam
and San Francisco, both having shown no toxicity, combined with
data generated from the Houston human clinical pilot study, upon
the consummation of the Merger, Hollis-Eden intends to
immediately commence clinical trials at Phase II/III levels,
although it is possible that the FDA may ask for additional Phase
I information.
REVERSIONEX
In December 1993, the initial IND package application was
submitted to the FDA, which requested additional data on
manufacturing of the anti-serum to AFP. The proposed
manufacturing agreement must be clarified to the FDA's
satisfaction to answer those particular questions that relate to
manufacturing processes. Hollis-Eden is currently in negotiations
with potential contract manufacturers and, upon the consummation
of the Merger, Hollis-Eden expects to select its contract
manufacturer in order to complete its IND filing. The planned
route of development will involve securing a manufacturing source
and proceeding with the Phase I study, most likely at a contract
facility. |
