Malaria Parasites Cleared in Patients With Hollis-Eden Pharmaceuticals Immune Regulating Hormone
Company Presents Clinical Trial Results At 50th American Society of Tropical Medicine and Hygiene
SAN DIEGO, Nov. 12 /PRNewswire/ -- Hollis-Eden Pharmaceuticals, Inc. (Nasdaq: HEPH - news) today announced preliminary results from a Phase II study treating Plasmodium falciparum malaria-infected patients in Thailand with the Company's lead investigational drug candidate, HE2000, an immune regulating hormone. Within the 7-day treatment period, 17 of the 21 patients achieved complete clearance of all malarial parasites, with 14 of the 21 patients completely clearing malaria during the first two days of treatment with the compound. Additionally, 16 of the 21 patients cleared fever within 48 hours of treatment. During the treatment period 19 of the 21 patients reached the primary endpoint of the study, which was a 50% reduction in parasite count. In addition, HE2000 was well tolerated in this study and no drug-related serious adverse events were reported. The results of the study are being presented today in a ``late breaker'' oral presentation at the 50th American Society of Tropical Medicine and Hygiene meeting being held in Atlanta, Georgia this week.
These clinical results parallel the positive effects seen with HE2000 in a number of preclinical malaria studies performed in collaboration with the U.S. Navy. The clinical trial, conducted by researchers at Mahidol University in Thailand, was the first in a series of planned studies in malaria with both injectable and buccal tablet formulations of HE2000. This initial protocol involved daily injections of a single dose level of HE2000 for seven consecutive days to patients infected with P. falciparum malaria.
``These are very exciting initial results with a potentially important new class of compounds that modulate the immune system,'' stated Dr. Sornchai Looareesuwan, Professor and Dean, Faculty of Tropical Medicine at Mahidol University, Bangkok, Thailand. ``It is very encouraging to see that even with the first clinical effort in this indication with HE2000 we are seeing rapid clearance of malaria in the great majority of patients. We are also encouraged by the very attractive safety profile observed to date. We look forward to conducting additional studies with HE2000 to optimize these effects even further. We also are interested in testing the compound in combination with other anti-malarial agents and in the setting of malaria prophylaxis. Based on its apparent ability to rapidly stimulate immune responses, there is a strong rationale for HE2000 in a number of other infectious diseases as well.''
The World Health Organization (WHO) estimates that between 300 and 500 million people become infected with malaria each year in over 100 countries resulting in 1 to 3 million deaths. More than 40% of the world's population is at risk. According to the WHO, the disease remains one of the major causes of morbidity and mortality worldwide. It is also estimated that up to 60% of all new malaria cases today are resistant to chloroquine, which has been the treatment of choice for many years. Resistance issues are now being seen with other anti-malarials as well, and there are side effects with current therapies that in some cases can be of significant concern. In the last several years a number of governmental and charitable organizations have sponsored major initiatives to help find new ways of combating malaria.
``This data is important for a number of reasons,'' stated Richard B. Hollis, Chairman and CEO of Hollis-Eden. ``Most importantly, malaria is a major world health problem which causes massive human suffering and has been shown to have significant effects on retarding economic growth in countries where it is epidemic. This data indicates HE2000 has the potential to be a safe, efficacious and cost-effective agent for malaria and because of its immune system-based mechanism of action, may avoid the resistance issues associated with the use of conventional anti-malarial agents.''
``In addition, these results provide strong validation for our scientific approach. Rather than directly targeting the pathogen, our approach has been to correct a dysregulated immune system and enable the immune system to do its job. We believe this data demonstrates that a pathogenic infection associated with a dysregulated immune system can be cleared by correcting the dysregulation. It is very exciting to see that, by using an immune regulating hormone in this setting, we appear to be able to quickly demonstrate important functional benefit to patients. Many of the same immune system defects that are present in malaria are also present in other conditions of immune dysregulation. These results with this new class of immune regulating drug candidates open up opportunities to demonstrate clinical benefit in a wide variety of infectious diseases, autoimmune conditions, cancer and age-related loss of immunity.''
HE2000 is the lead compound in a series of immune regulating hormones being developed by Hollis-Eden. Immune regulating hormones and hormone analogs are designed to regulate gene transcription to control immune function. In initial clinical trials in HIV patients, HE2000 appears to reduce chronic inflammatory responses while also boosting innate and cell-mediated immunity. The Company believes that the effects on innate immune function (the immune system's first line of defense against pathogens) may be driving many of the beneficial effects seen in malaria. Preclinical activity has also been demonstrated with HE2000 and other immune regulating hormones in models of a number of other infectious diseases, autoimmune disorders and cancer-related applications.
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. Hollis-Eden is conducting a series of clinical trials with HE2000 in South Africa and the United States in HIV infected patients and has recently commenced clinical trials with HE2000 in Singapore for the treatment of hepatitis B and in Thailand for malaria-infected patients. Studies with the Company's immune regulating hormones are also planed in hepatitis C infected patients. The Company is also conducting a Phase I clinical trial in the United States with another of its immune regulating hormones, HE2200. In addition, through its relationship with Aeson Therapeutics, the Company also has access to HE2500, which is in clinical trials in the United States in cardiovascular disease and actinic keratosis. For more information on Hollis-Eden, contact the Company's website at www.holliseden.com. |
