preclinical related Press Releases

PRESS RELEASE: Hollis-Eden Pharmaceuticals Presents HE3235 Update at ASCO Breast Cancer Symposium

Maureen Martino — Fri, 07 Sep 2007 10:58:48 -0400

Hollis-Eden Pharmaceuticals Presents HE3235 Update at ASCO Breast Cancer Symposium

Preclinical Data Show Lasting Anti-Tumor Effect of Novel Drug Candidate

SAN DIEGO -- Hollis-Eden Pharmaceuticals, the leader in the development of a new class of small molecule compounds based on endogenous steroid hormones, today reported on its progress with HE3235, its investigational oral drug candidate for the treatment of cancer. Data being presented today at The 2007 ASCO Breast Cancer Symposium, being held September 7-8 in San Francisco, California, demonstrate that HE3235, as previously reported, significantly inhibited the incidence of new tumors and stopped the growth of existing tumors in a preclinical model of breast cancer. Updated data presented at this conference indicate that existing tumors in the HE3235-treated animals from this preclinical model had still not progressed and no new tumors were reported during the five weeks of observation after dosing stopped, in contrast to the vehicle-treated animals in which tumors continued to proliferate. Additionally, the Company reported that when animals with existing tumors were dosed at one half the strength of the lowest dose previously tested, HE3235 stopped tumor progression in these animals.

The new data indicating that the anti-tumor benefit of HE3235 was sustained for five weeks after dosing stopped are striking in light of the fact that approved breast cancer treatments lose activity once treatment is discontinued. The Company plans to file an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) in the first quarter of 2008 in order to initiate a planned Phase I/II clinical trial with HE3235 for the treatment of cancer.

The previously reported data being presented at the Breast Cancer Symposium are from an animal model in which rats were given the potent carcinogen N-methyl-N-nitrosourea to induce multiple breast tumors. Animals with detected tumors were randomized to receive one of two strengths of HE3235 or assigned to a placebo control group. Treatment with HE3235 resulted in a reduced tumor burden for existing tumors that were present before treatment commenced compared to placebo-treated animals (p less than 0.001). In addition, after the treatment period began, all placebo control treated animals developed one or more additional tumors, while not a single new tumor arose in the animals treated with HE3235. This preventive action of HE3235 on the occurrence of new tumors also reached statistical significance (p less than 0.01).

“The effect of HE3235 to inhibit new tumor growth and stop tumor progression in this model was impressive, but what was unexpected and exciting was that the compound appeared to have a lasting effect even after dosing was stopped,” stated Dr. Rajkumar Lakshmanaswamy, Assistant Professor, Department of Pathology, Texas Tech University Health Sciences Center, who conducted the study and reported on the findings at the ASCO symposium.

“These data hold the promise that HE3235, if successfully developed, could offer a new treatment option for women with breast cancer,” stated Richard B. Hollis, Chairman and Chief Executive Officer of Hollis-Eden. “The lasting anti-tumor effect of HE3235 reported in this animal model of breast cancer suggests the compound is causing tumor cells to undergo apoptosis, or die. Therefore, the compound may act through a novel mechanism of action that could make it useful in treating multiple types of cancer. Due to this potential and the previously reported activity with HE3235 in prostate cancer models, we are aggressively pursuing the mechanism of action and the activity of the drug candidate in other models of cancer. HE3235 represents yet another novel pharmaceutical drug candidate developed out of our hormone signaling technology platform and yields a program in cancer to augment our expanding drug development pipeline in metabolic disorders and diseases of inflammation, such as type 2 diabetes and rheumatoid arthritis.”

Currently the leading approved drug treatments for prostate or breast cancer focus on blocking the effects of testosterone or estrogen and generate annual sales ranging from approximately $500 million to $2 billion.

Hollis-Eden Pharmaceuticals

Hollis-Eden Pharmaceuticals, Inc. is a world leader in the development of a proprietary class of adrenal steroid hormones as novel pharmaceuticals for human health. Through its Hormonal Signaling Technology Platform, Hollis-Eden is developing a new series of small molecule compounds that are metabolites or synthetic analogs of endogenous hormones derived by the adrenal glands from the body’s most abundant circulating steroid. These steroid hormones, designed to restore the biological activity of cellular signaling pathways disrupted by disease and aging, have been demonstrated in humans to possess several properties with potential therapeutic benefit -- they regulate innate and adaptive immunity, reduce nonproductive inflammation and stimulate cell proliferation. The Company’s clinical drug development candidates include HE3286, a next-generation compound currently in a clinical trial for the treatment of type 2 diabetes and being prepared for potential clinical trials in rheumatoid arthritis, and HE3235, a next-generation compound selected for cancer. In addition to these clinical development candidates, Hollis-Eden has an active research program that is generating additional new clinical leads that are being further evaluated in preclinical models of a number of different diseases. For more information on Hollis-Eden, visit the Company’s website at www.holliseden.com.

This press release contains forward-looking statements within the meaning of the federal securities laws concerning, among other things, the potential and prospects of the Company's drug discovery program and its drug candidates. Any statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause the Company's actual results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such statements are subject to certain risks and uncertainties inherent in the Company's business, including, but not limited to: the ability to complete preclinical and clinical trials successfully and within specified timelines, if at all; the ability to obtain regulatory approval for HE3286, HE3235 or any other investigational drug candidate; the Company's future capital needs; the Company's ability to obtain additional funding; the ability of the Company to protect its intellectual property rights and to not infringe the intellectual property rights of others; the development of competitive products by other companies; and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by law, the Company undertakes no obligation to update or revise the information contained in this press release as a result of new information, future events or circumstances arising after the date of this press release.

PRESS RELEASE: FermaVir Announces Positive Data from Recent Preclinical Studies of FV-100

Wed, 08 Aug 2007 12:52:18 -0400

FermaVir Announces Positive Data from Recent Preclinical Studies of FV-100

FermaVir Pharmaceuticals, Inc. today announced positive results from preclinical studies evaluating FV-100, a highly potent, orally bioavailable bicyclic nucleoside analogue for the treatment of herpes zoster infection (shingles). In the preclinical toxicology studies, the compound was generally safe and well tolerated in animals at dose levels that are expected to exceed a therapeutically relevant dose. In addition, preclinical pharmacokinetic studies indicated that single oral doses of FV-100 can produce prolonged plasma concentrations over twenty-four hours, suggesting the potential for a once-a-day dosing regimen.

"This encouraging data builds on prior published preclinical data demonstrating the antiviral activity of FV-100 against varicella zoster and its potential to further reduce the symptoms associated with shingles, such as acute pain and post-herpetic neuralgia ("PHN")," stated Geoffrey Henson, Ph.D., chief executive officer of FermaVir. "Importantly, the data reinforces our belief that FV-100 has the potential to be a more potent treatment option for shingles with the advantage of a favorable safety profile and once-a-day dosing regimen as compared to currently-available therapies, and provides a path forward for filing an Investigational New Drug ("IND") Application in the near future and commencing the clinical development of FV-100."

In the preclinical studies, FV-100 was administered as a single oral dose at 100 mg, 500 mg, or 2,000 mg/kg in both rats and dogs. Following a 14-day observation period, toxicity data from both species revealed no mortalities or significant adverse events. Additionally, genotoxicity and phototoxicity studies were also negative.

Pharmacokinetic analysis indicated at the lowest dose level, a single oral dose of FV-100 resulted in plasma levels at 24 hours of CF-1743, the active form of FV-100, which exceeded the amount required to inhibit 90% (EC90) of the replication of varicella zoster virus. The EC90 is a measure of the amount of a compound which inhibits 90% of the virus in vitro. Taken together, FV-100 appears to be safe and well tolerated in rats and dogs over the ranges and duration of exposure examined.

Published in vitro studies demonstrate that FV-100, a prodrug of CF-1743, is the most potent compound among antivirals in development or approved for the treatment of shingles. Further, based on its exceptional ability to rapidly enter cells and quickly inhibit viral replication, FV-100 has the potential to further reduce all shingles-related symptoms, including the incidence and the severity of acute pain and post-herpetic neuralgia (PHN), a painful condition caused by damage to the nerves during the active viral infection.

About FermaVir

FermaVir Pharmaceuticals, Inc. is a biotechnology company focused on the development of important antiviral drugs in underserved segments of the pharmaceutical development marketplace. FermaVir's most advanced program is FV-100, a compound currently being developed for the treatment of shingles. FermaVir is also developing a series of compounds that could improve the treatment of Cytomegalovirus (CMV) infection, a currently incurable viral disease that can threaten eyesight as well as cause severe morbidity and mortality mostly in the immunosuppressed. FermaVir's Intellectual Property portfolio includes a number of patent applications and a worldwide exclusive license for potential new drug treatments of infectious diseases. On April 10, 2007, FermaVir announced that it has entered into a definitive agreement to merge with Inhibitex, Inc., which is expected to close in September 2007. For additional information about FermaVir, please visit www.fermavir.com.

Additional Information about the Merger and Where to Find It

In connection with the proposed merger, Inhibitex and FermaVir have filed relevant materials with the Securities and Exchange Commission (SEC), including a registration statement on Form S-4 that contains a prospectus and a joint proxy statement. The registration statement has not yet been declared effective by the SEC. Investors and security holders of Inhibitex and FermaVir are urged to read these materials when they become available because they will contain important information about Inhibitex, FermaVir and the merger. The proxy statement, prospectus and other relevant materials (when they become available), and any other documents filed by Inhibitex and FermaVir with the SEC, may be obtained free of charge at the SEC's web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by Inhibitex by directing a written request to: Inhibitex, 9005 Westside Parkway, Alpharetta, GA 30004, Attention: Investor Relations; and documents filed with the SEC by FermaVir by directing a written request to FermaVir, 420 Lexington Avenue, Suite 445, New York, N.Y. 10170, Attention: Investor Relations. Investors and security holders are urged to read the proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the merger.

Participants in the Solicitation

Inhibitex and FermaVir and their respective directors, executive officers and employees may be deemed to be participants in the solicitation of proxies from the stockholders of Inhibitex and FermaVir in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the merger transaction will be included in the proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of Inhibitex is also included in Inhibitex's Amendment No. 1 to the Annual Report on Form 10-K for year ended December 31, 2006. This document is available free of charge at the SEC's web site (www.sec.gov) and from Investor Relations at Inhibitex at the address set forth above. Additional information regarding the directors and executive officers of FermaVir is also included in FermaVir's Annual Report on Form 10-KSB for the year ended April 30, 2007. This document is available free of charge at the SEC's web site (www.sec.gov) and from Investor Relations at FermaVir at the address set forth above.

Safe Harbor Statement

Some of the statements included in this press release are forward-looking statements that involve a number of risks and uncertainties, including, but not limited to: statements regarding the proposed acquisition, future market opportunity and future financial performance. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Important factors may cause our actual results to differ materially, including, but not limited to, the satisfaction of the conditions to the closing of the pending merger transaction with Inhibitex, including approvals by the stockholders of both corporations, the Board of Directors of neither FermaVir nor Inhibitex withdrawing its support for the pending merger transactions, uncertainties associated with product development, the risk that FermaVir will not obtain approval to market its products, the risk that FermaVir technology will not gain market acceptance, the risks associated with dependence upon key personnel, the need for additional financing; and other cautionary statements contained elsewhere herein and in FermaVir's Annual Report on Form 10-KSB for the year ended April 30, 2007, as filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.