information recently released, is this good
Sep 6, 2003
I am sending this to you because i feel that it is some breakthrough info regarding HE2000. I would like to know if there is anyway we can help bring this product to approval here in US to treat HIV. What is your outake?
Hollis-Eden Pharmaceuticals Presents Data Demonstrating Statistically Significant Reduction In Opportunistic Infections In Late Stage Aids Patients Treated With HE2000
San Diego, California -- June 23, 2003 --Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) today announced additional data from a Phase II clinical trial conducted in South Africa in late-stage HIV patients who have progressed to AIDS (average starting CD4 count for patients in the trial <50). Patients in this study treated with IMMUNITIN (HE2000), the Companys lead investigational compound for infectious disease, experienced a statistically significant reduction in the total number of all opportunistic infections (OIs) over the thirteen month study period when compared to patients receiving placebo. Dr. James M. Frincke, Chief Scientific Officer of Hollis-Eden Pharmaceuticals, is presenting data from this trial at the National Foundation for Infectious Diseases Conference on Antimicrobial Resistance, being held this week in Bethesda, Maryland.
There were 25 evaluable patients in the study who were dosed once a day with either IMMUNITIN or placebo for 5 days and then observed for 5 weeks before receiving and additional 5-day treatment course. This schedule was repeated for up to a total of 7 courses and patients were monitored for approximately 400 days. Over this treatment course, patients in the placebo group experienced 67 more opportunistic infections than those treated with IMMUNITIN (p=0.03). Patients treated with IMMUNITIN also experienced a statistical trend towards reduced circulating C - reactive protein (CRP) compared to placebo treated patients (p=0.10). C - reactive protein is a well-known marker for inflammation. Published reports in the medical literature indicate inflammation is closely associated with disease progression in HIV/AIDS. IMMUNITIN therapy was generally well tolerated in this study, with transient pain and inflammation at the injection site being the most common drug related adverse event. The study was a feasibility study to aid in the design of a larger study powered to show statistical differences in delaying time to opportunistic infections in HIV patients.
This result is what you would hope to see from an immune therapy for AIDS patients, stated Dr. James Frincke, Chief Scientific Officer for Hollis-Eden. In addition, its exciting to see a statistically significant result in late stage patients where opportunistic infections are expected. We believe this is the first time an immune modulator has shown significant benefit against a hard clinical endpoint like the cumulative number of opportunistic infections in late-stage AIDS patients. We reported at the last World AIDS Conference in Barcelona, that in earlier stage HIV-infected patients, HE2000 normalized inflammatory cytokines such as TNF alpha and IL-1 beta, while stimulating dendritic cells and improving specific immune responses to HIV, which we have always believed would result in strengthening an HIV-infected patients immune system enough to ward off infections. This positive result is validating our hypothesis. This may open up several new avenues for us in designing a smaller and more rapid pivotal study than we originally anticipated would be necessary for gaining approval.
This is very important data, said Richard Hollis, Chairman and CEO, Hollis-Eden Pharmaceuticals, Inc. We believe that the ability to show this type of benefit in a very sick patient population argues strongly for the need to conduct larger studies in this area. We are eager to share this data with all of the key stakeholders in medicine, government and industry who are concerned about the enormity of the impact of the global HIV epidemic. Delaying disease by strengthening the immune system is clearly a goal not just in late stage progression of AIDS but also in earlier stage disease to delay the use of expensive drugs that result in complications from resistance and toxicity. Moreover it has always been our vision of using IMMUNITIN to convert HIV-infected patients into long-term non-progressors. We believe that if we could correct the immune dysregulation caused by HIV with HE2000, it would be possible to slow the progression of the disease and reduce the incidence of opportunistic infections. Death in this disease is a result of opportunistic infections. Key health organizations and governmental bodies have now raised large sums of money to combat the three infectious diseases that are wreaking the most devastation around the globe today: HIV, malaria and tuberculosis (TB). There is an increasing recognition amongst these groups that, like the emerging biodefense industry, appropriate incentives need to be put in place if the private sector is expected to provide practical new treatments for these conditions. IMMUNITIN has now shown exciting activity in multiple clinical studies in both HIV and malaria and has also demonstrated benefit in preclinical studies of TB, has an attractive safety profile to date in over 200 patients and is cost-effective to produce. We believe that given these attributes, IMMUNITIN is an appropriate drug candidate for the type of public/private partnership that can lead to the successful development of practical new therapies that are affordable and economically sustainable throughout the world. Our goal is to provide solutions to the global pandemic. We look forward to continuing to work with all of these global stakeholders to structure such a mutually beneficial relationship.
Hollis-Eden Pharmaceuticals, Inc. is a development-stage pharmaceutical company based in San Diego, California, working to become the world leader in the development of a new class of investigational drugs known as Immune Regulating Hormones (IRHs). The goal of IRH therapy is to direct, through controlling gene expression, the production of key cytokines and enzymes that re-regulate immune and metabolic functions toward homeostasis, a profile that could be useful in a wide variety of diseases. The Company has a number of investigational IRHs under development, including HE2100, which the Company is co-developing with the U.S. military for use in protection from radiation injury and HE2000, which are currently being studied in a number of infectious diseases. Hollis-Eden is also developing an additional IRH, HE2200, for improving vaccine responses in the elderly and for lowering cholesterol in conditions of hypercholesterolemia. For more information on Hollis-Eden, contact the Company's website at http://www.holliseden.com/
This press release contains forward-looking statements concerning the potential and prospects of the Companys drug discovery program and its drug candidates. Any statement describing a goal, expectation, intention or belief of the Company is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including the failure to successfully complete clinical trials, the Companys future capital needs, the Companys ability to obtain additional funding and required regulatory approvals, 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 Companys filings with the Securities and Exchange Commission. The actual results may differ materially from those contained in this press release.
Response from Dr. Young
This is encouraging information about HE2000- and while the initial findings were also encouraging, the new news (if confirmed) is that there are more than just laboratory benefits to the product, but a reduction in clinical events- namely complications.
It is curious to me that the study was presented at this particulary meeting, since it receives little (or no) attention from the usual cast of HIV media, HIV academics, etc. Hence, we (I) haven't had a chance to actually look at the data that was presented.
I should place a cautionary note though-- as a community, I believe very strongly that medical science should not be practiced through the use of press releases. Commentary from the chief scientists at the company that owns the product should be viewed with extreme circumspection; phase II compounds are not yet proven drugs (with proven safety, proven efficacy)-- indeed a majority of phase II compounds never get past the next stage of clinical trials (phase III) nor get FDA approval. BY
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