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Biotech / Medical : Hollis Eden Pharmaceuticals Inc. (HEPH) -- Ignore unavailable to you. Want to Upgrade?

To: BDR who wrote (16)	2/17/1998 11:41:00 PM
From: flickerful	Respond to of 138

it is an eye-catching name, eh...<eom>

To: BDR who wrote (16)	2/19/1998 7:21:00 PM
From: Pullin-GS	Read Replies (2) \| Respond to of 138

Went short today

To: BDR who wrote (16)	2/20/1998 8:20:00 AM
From: BDR	Respond to of 138

STOCK STUFF From the SEC filings on EDGAR I see that the President, Peizer, has been granted some stock options at $5/share. " Mr. Peizer was granted options to purchase up to 2,400,000 shares of Hollis-Eden Common Stock on February 5, 1997. None of these options are currently exercisable. These options vest in annual one-sixth increments commencing on February 5, 1998. See "PROPOSED MANAGEMENT OF THE SURVIVING CORPORATION - Employment Agreements." At the recent price, he just made about $5 million. Other interesting info: "In addition, Mr. Richard B. Hollis and Dr. Patrick T. Prendergast, the owners of approximately 71% of the outstanding Hollis-Eden Common Stock, agreed with Hollis-Eden not to sell more than an aggregate of 1,000,000 shares of Surviving Corporation Common Stock to be received by them as a result of the Merger for the two-year period commencing upon the Effective Time of the Merger. " Effective time? November 5, 1996 (the last trading day prior to the public announcement of the execution of the Merger Agreement) is mentioned. Based on the 13G filed 2/12 it would appear that about 6.7 million shares have been authorized. 9.59 million registered per the S 4/A as of 2/97. Not sure which is correct. Someone more familiar with these types of documents help me out.

To: BDR who wrote (16)	2/20/1998 8:24:00 AM
From: BDR	Respond to of 138

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.