HEPH's decline arrested on more news:
Hollis-Eden to Begin Phase I/II U.S. Clinical Trial with Unique Approach to Stopping HIV; New Drug Attempts to 'Starve' the Virus of Energy Source
SAN DIEGO, March 1 /PRNewswire/ -- Hollis-Eden Pharmaceuticals, Inc. (Nasdaq: HEPH - news) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that they may initiate dosing in a U.S. Phase I/II clinical trial for HE2000, an investigational new drug for the treatment of HIV/AIDS.
MECHANISM OF ACTION
HE2000 is believed to work by inhibiting the host cell's energy-producing enzymes and proteins, thereby ''starving'' the virus of the energy that it needs to replicate. Other anti-retroviral therapies block the action of viral, not cellular, proteins needed for replication. Though temporarily effective, currently approved anti-HIV drugs can and have been foiled by HIV mutation that displaces the targeted protein structure, resulting in drug resistance. Because HE2000 therapy does not directly inhibit specific viral proteins, it has the potential, if effective, to be a more durable treatment and is unlikely to lose effectiveness due to viral mutation and the resulting drug resistance.
''What's different about our approach is that this drug protects against the disease-causing agent by acting on the host cell's biochemical mechanism,'' said James Frincke, Ph.D., vice president of research and development at Hollis-Eden.
Pre-clinical in vitro testing of HE2000 demonstrated significant activity by inhibiting various strains of HIV, including wild-type, reverse transcriptase inhibitor (RTI)-resistant and multiple drug-resistant strains.
''This is an important step in testing new approaches for the treatment of AIDS,'' said Thomas C. Merigan, M.D., George and Lucy Becker professor of medicine and director of AIDS research at Stanford University. ''Drug resistance to currently approved therapies for AIDS continues to emerge. Because of this, we need to find new drugs that offer more durable, less toxic and more affordable treatment options.''
TRIAL INFORMATION
The Phase I/II trial will evaluate HE2000 in treatment-experienced HIV-infected patients to determine the safety, tolerance, pharmacokinetics and anti-HIV activity of the drug. Patients will be monitored during dosing and up to three months following the completion of the treatment regimen. The trial will be conducted at selected sites in the San Francisco Bay area, Chicago and Houston.
PROBLEMS WITH CURRENT TREATMENTS
The current recommended standard of care for anti-HIV drug therapy consists of combinations of drugs such as RTIs and protease inhibitors (PIs).
At the 12th World AIDS Conference in Geneva last year, it was reported in studies that up to 54% of patients taking anti-HIV drug combinations had developed resistance to the drugs and were failing therapy.
Other drawbacks to current therapies are high cost (estimated at $10,000 to $23,000 per year), short- and long-term side effects and patient non-compliance due to the complex dosing regimen. These issues have made it especially difficult for developing countries to implement anti-HIV drug programs.
DISEASE PREVELANCE
More than 33 million adults and children worldwide are living with HIV/AIDS, according to the World Health Organization and the Joint United Nations Programme on HIV/AIDS. Nearly six million people became infected with HIV in 1997 alone. By the year 2000, 40 million people worldwide are expected to be infected.
SOURCE: Hollis-Eden Pharmaceuticals, Inc.
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FWIW, other companies are pursuing this approach for treatment of cancer, to which it seems to have real applicability. Since HEPH isn't disclosing the nature of the drug they've identified as "HE2000" it's impossible to say whether using this approach to treat HIV/AIDS has any scientific validity. |
