Business Wire - July 8, 2002
The preliminary results are from a placebo-controlled trial in 24 HIV-infected subjects who were treatment naive prior to enrolling in the study. Patients received three cycles of daily subcutaneous injections for 5 consecutive days of either a 50 mg or a 100 mg dose of HE2000 or placebo every six weeks and were followed for an additional 12 weeks after the last dosing cycle. Findings include a downward slope in viral load during the study period in the 100 mg dose group and the maximum viral load reduction (0.45 log) was observed at the end of the study, although this result did not reach statistical significance. However, in the 50 mg dose group there was a statistically significant downward slope in viral load versus placebo during the study period (p less than 0.01), and the maximum viral load reduction from baseline (0.66 log) was seen at the end of the 30 week study, 12 weeks after the patients' last treatment course.
HE2000 treated patients also experienced increases in a number of cell types associated with innate and adaptive cell-mediated immunity throughout the course of the study including killer cells, dendritic cells and Th1 cells, whereas levels of these cells in the placebo group generally declined over the course of the study. These changes in the 18 HE2000 treated patients were statistically significant versus the 6 placebo treated patients (p less than 0.05). Reports in the medical literature indicate that patients able to mount a strong innate and/or cell-mediated immune response experience fewer opportunistic infections and are able to delay the onset of AIDS.
In addition, an analysis performed on 8 patients in the study for which data is currently available indicated new HIV gag specific T-cell responses were induced after the second treatment course in 4 out of 6 patients treated with HE2000, and these responses were not seen in the 2 placebo treated patients. HIV gag specific T-cell response is a marker that is increasingly being used by the research community as an indicator of functional immune response to HIV. A number of leading researchers in the medical community believe that increasing HIV specific T-cell responses can lead to a reduction in the viral setpoint for patients with HIV, which could also delay disease progression.
These results complement the previously announced finding from this study that HE2000 had a statistically significant effect on inflammatory mediators. Prior to receiving HE2000, patients in this study had significantly elevated transcript numbers of a wide variety of important inflammatory mediators including TNF-alpha, Cox-2, IL-1 and IL-6. After receiving HE2000, levels of all of these inflammatory mediators approached normal values. These reductions were maintained throughout the study. Chronic inflammation in HIV patients has been associated with progression towards a number of AIDS defining conditions, and reducing these inflammatory mediators has the potential to help delay disease progression.
Administration of HE2000 was generally well tolerated by patients in this study, with no drug-related serious adverse events reported. The most commonly reported treatment related side effect was mild to moderate injection site reaction. Hollis-Eden has now treated over 150 patients in various Phase I/II and Phase II clinical trials
"We are quite excited by the results of this study," stated Dwight Stickney, M.D., Medical Director at Hollis-Eden. "As an immune modulator, we have been focusing on the effects of HE2000 on a number of parameters of immune function that are correlated with delaying disease progression towards AIDS rather than the traditional marker of viral load that is used with antiviral drugs. Thus, it is very encouraging to see in this study that, in addition to having beneficial effects on a number of markers of immune function (as we had seen in a previous study using intramuscular administration of HE2000), in this study using a subcutaneous route of administration, we are also observing that the trend line for viral load continued to decline over the course of the 8 month study. This viral load reduction is significant because it demonstrates immunologic control of HIV replication verses a direct antiviral mechanism, particularly given that HE2000 was administered as a single agent on an intermittent basis rather than as part of a drug cocktail given daily."
Richard Hollis, Chairman and CEO of Hollis-Eden, added: "These findings are important for a number of reasons. It's the first demonstration that HE2000 treatment, when used as a monotherapy, was able to have a positive effect on key immune system parameters as well as viral load in HIV-infected patients. This data suggests that with the right dose and route of administration of HE2000 it may be possible, immunologically, to control HIV replication and enhance immunity, with the ultimate goal of converting more HIV infected patients into long-term non-progressors. Given our previously announced positive clinical trial results with HE2000 in malaria and the fact that HE2000 has been generally well tolerated in the treatment of over 200 patients in a variety of indications, we believe HE2000 has the potential to become a broad spectrum agent for use against a number of important infectious diseases plaguing the world today by correcting the underlying immune dysregulation. It is also encouraging to see that in this disease of profound immune dysregulation, HE2000 has shown an ability in humans to simultaneously reduce a number of important inflammatory mediators while boosting a number of cell-types associated with innate and cell-mediated immunity. Inflammation and loss of immunity are associated with a multitude of conditions well beyond infectious disease. Our results with this class of compounds continue to support their potential broad utility in areas which also include radiation induced immune suppression, autoimmunity, cardiovascular disorders and a number of diseases related to aging and loss of immunity."
Hollis-Eden Pharmaceuticals, Inc. is a development-stage pharmaceutical company based in San Diego, California, engaged in the development of products for the treatment of infectious diseases and immune systems disorders. The Company's vision is to become the world leader in immune regulating hormones and their application to numerous diseases. HE2000 is the Company's lead investigational drug and is currently being studied in clinical trials for HIV/AIDS in South Africa. Hollis-Eden is also conducting a Phase I/II clinical trial with HE2000 in the United States in HIV infected patients failing at least their second antiviral drug regimen. Phase II studies in Thailand are also being conducted with HE2000 for the treatment of malaria, and in Singapore for the treatment of hepatitis B. In addition, Hollis-Eden recently entered into a Cooperative Research and Development Agreement (CRADA) with the United States Department of Defense to develop HE2100 as a radioprotectant (a drug that may potentially be used to protect a person from radiation injury due to a nuclear accident or event). Hollis-Eden has also initiated a Phase I/II clinical trial with HE2200 for vaccine potentiation in elderly patients receiving a hepatitis B vaccine. In addition, the Company has access to another immune regulating hormone, HE2500, through its relationship with Aeson Therapeutics. HE2500 is currently being studied in a Phase II clinical trial in cardiovascular disease. For more information on Hollis-Eden, contact the Company's website at www.holliseden.com.
This press release contains forward-looking statements concerning the potential and prospects of the Company's drug discovery program. 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 Company's future capital needs, the Company's ability to obtain additional funding and required regulatory approvals, 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. The actual results may differ materially from those contained in this press release.
CONTACT: Hollis-Eden Pharmaceuticals Inc., San Diego Dan Burgess, 858/587-9333, ext. 409
SOURCE: Hollis-Eden Pharmaceuticals Inc.
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