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IN THE

 

 

                                                                                              SETBACK

 

       A combination treatment comprising Avastin, developed by Genentech (DNA) and gemcitabine chemotherapy failed to meet the primary endpoint of overall survival in Phase 3 trial for advanced pancreatic cancer. The combination was intended as first-line treatment. The trial was stopped at the recommendation of an independent data monitoring board based on an interim analysis indicating that it is very unlikely that significant differences in overall survival will be shown between treatment arms as the data mature. The study was not stopped due to safety events and no new safety concerns related to Avastin were observed in this trial. Data from the study will be presented at an upcoming medical meeting.

 

READ MORE: Phase III Study of Avastin(R) in Advanced Pancreatic Cancer Does Not Meet Primary Endpoint

 

                                                                       

                                                    PREVENTING FROM BIOTERRORISM

 

       Hollis-Eden Pharmaceuticals (HEPH) announced today that it has been informed by the Department of Health and Human Services (HHS), in a letter dated June 23, 2006, that Hollis-Eden "is within the competitive range for discussion and further evaluation" with respect to Hollis-Eden's response to HHS' Request for Proposal No. DHHS-ORDC-DDA-05-12 entitled "Medical Countermeasures to Mitigate or Treat Neutropenia Alone or in Combination with Co-Morbidities Associated with Acute Radiation Syndrome (ARS)." This formally begins the negotiation process for a potential procurement. HHS indicated in their letter that the new estimated date of award is September 15, 2006.

        The drug the government is interested in is Neumune™ (HE2100), which is being developed for the treatment of Acute Radiation Syndrome, or ARS. In ARS, radiation damages the production of neutrophils or white blood cells that protect against opportunistic infections (neutropenia). It danmages platelets, key clotting elements that protect against bleeding episodes (thrombocytopenia) and red blood cells that carry oxygen to the cells (anemia). Each of these conditions can contribute to death in the first 30 to 60 days following radiation exposure. If an individual can survive this initial period of insult, the bone marrow will generally return to normal production of these critical blood cell components.


There is an urgent need today for a practical ARS therapy that can be used on a widespread basis in the event of the very real possibility of terrorists exploding a nuclear or radiological device.


 In addition to the ARS, Hollis-Eden has filed an Investigational New Drug (IND) application with the FDA to begin Phase I clinical trials with Neumune™ in patients at high risk of developing hospital-acquired infections — the fourth leading cause of death in the United States today.

READ MORE: Hollis-Eden Pharmaceuticals Provides Update on Status of NEUMUNE RFP for Acute Radiation Syndrome

 

  



 



 
   

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