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Biotech / Medical : Hollis Eden Pharmaceuticals Inc. (HEPH)

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To: BDR who wrote (40)3/20/1998 7:18:00 PM
From: BDR  Read Replies (1) of 138
 
In February, 1997, Inactivin was DHEA. In February, 1998, Inactivin is now PPB2. What's the difference between a formulation and an analog? Sounds like we are talking about the same thing.

From the recent press release (http://biz.yahoo.com/prnews/980209/ca_hollis__1.html)

The company recently developed PPB2, trade named (INACTIVIN) a new analog of the
company's lead drug candidate, that has a unique mechanism of action for antiretroviral...

The following is from the S4/A filed 2/97.

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.
treatment in HIV/AIDS and other infectious diseases.
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