From rxpgnews.com
Immune Regulating Hormone (IRH) for the Treatment of Acute Radiation Syndrome (ARS) Starts Phase I Clinical Trials
By Hollis-Eden Pharmaceuticals
Apr 1, 2005, 18:30
Hollis-Eden Pharmaceuticals, Inc. (Nasdaq:HEPH) today announced that it has initiated the first in a series of Phase I safety and pharmacokinetic (PK) clinical trials with NEUMUNE(TM) (HE2100), its investigational immune regulating hormone (IRH) for the treatment of Acute Radiation Syndrome (ARS).
This first study is being conducted in the Netherlands. The Company also stated that it continues to expect to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the first half of 2005 to initiate clinical studies in the U.S. Safety and PK study results are expected to be available in a timeframe that enables the Company to initiate a pivotal efficacy study in non-human primates in the second half of 2005.
Hollis-Eden is developing NEUMUNE under an FDA rule (the Animal Efficacy Rule) designed for medical countermeasures to weapons of mass destruction. Pursuant to this rule, for indications in which it would be unethical to conduct efficacy studies in humans (as is the case with radiation injury), approval may be granted on the basis of efficacy in relevant animal species and safety in humans.
The purpose of the Phase I studies, in addition to analyzing safety, is to determine the concentration of NEUMUNE that can be achieved in human blood. This PK information can then be used in selecting the final dose for the pivotal efficacy study in non-human primates. Under the Animal Efficacy Rule, matching the drug levels in humans with that which produces efficacy in the appropriate animal species is a requirement for approval.
By comparing the concentration of NEUMUNE that can be achieved in humans to that which has already been established in non-human primates, the Company expects to be able to match the dose most likely to achieve efficacy in the pivotal study with a dose that is achievable and tolerable in humans.
As previously disclosed, Hollis-Eden has conducted and reported on both sublethal and lethal radiation studies in over 200 non-human primates. In sublethal studies, NEUMUNE has demonstrated a reduction in the incidence of neutropenia, thrombocytopenia and anemia compared to animals not receiving the drug.
In lethal studies, NEUMUNE demonstrated a reduction in both febrile neutropenia and severe thrombocytopenia, as well as a survival benefit as compared to animals not receiving NEUMUNE.
Hollis-Eden is pursuing an advance purchase contract under Project BioShield to provide NEUMUNE to the U.S. government for use by the military, first responders and civilians who may be at risk of radiation injury. Given the accelerated potential development path for NEUMUNE and the significant need for compounds that can treat ARS, Hollis-Eden has made development of NEUMUNE for this indication a top priority.
In October 2004 the Department of Health and Human Services (HHS) issued a Request for Information (RFI) for therapeutics to treat neutropenia and thrombocytopenia associated with ARS. An RFI begins a process by which the government can contract with industry for large-scale manufacturing and delivery of licensable products to the Strategic National Stockpile in preparation for response to a public health emergency. Hollis-Eden submitted a formal response to the RFI in December 2004.
While there can be no assurances that Hollis-Eden will be requested to participate, the next step in the procurement process is expected to be the issuance by HHS of a Request for Proposal (RFP) detailing initial stockpiling requirements for qualified bidders.
"The initiation of Phase I studies with NEUMUNE marks a meaningful milestone in our development program for ARS," stated Richard B. Hollis, Chairman and CEO of Hollis-Eden Pharmaceuticals. "By initiating these studies in the Netherlands, we are able to generate valuable safety and PK information expected to support the design of our pivotal studies, at the same time that we are preparing and filing our IND for U.S. Phase I studies. Given the gravity of a potential nuclear or radiological terrorist attack on our nation, it is imperative that development of new medical countermeasures for this threat be advanced as rapidly as possible. Accordingly, we are pleased to be able to announce this important step forward in our development program for NEUMUNE."
ARS, also referred to as radiation sickness, is an acute illness caused by high doses of radiation exposure over a significant portion of the body in a relatively short time period. This exposure results in the depletion of hematopoietic stem cells and progenitors, resulting in severe neutropenia (loss of neutrophils) and thrombocytopenia (loss of platelets), which if left without medical support can significantly increase an individual's susceptibility to life threatening infections and bleeding.
According to medical literature, casualty estimates for a relatively small nuclear device detonated in a major U.S. city indicate that hundreds of thousands of people would be exposed to life threatening ARS. Today there are no therapeutics approved to mitigate ARS, and current treatment recommendations would involve antibiotics, platelet transfusions and expensive bone marrow growth factor therapy administered by a physician in a hospital.
According to 2005 statistics from the American Hospital Association, most states normally have fewer than 20,000 hospital beds available on a given day, which could be insufficient in a nuclear attack scenario. The ability to provide a safe and practical medical countermeasure for ARS with a single agent has the potential to make NEUMUNE useful in a mass casualty scenario.
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