NEWS & COMMENTS

PROHOST    FILTER

           ANTI-ANGIOGENESIS            

    Targeting vascular endothelial growth factor to halt the growth of blood vessels that sustain cancer growth or cause macular degeneration in the eyes of elderly has become a primary topic for researchers. In Universities and in private and public companies and research institutions, researchers are exploring the effects and side effects of preventing VEGF from growing arteries through inhibition or blockage to treat various cancers, macular degeneration and other diseases that have yet to find a cure. Recently, researchers at Beth Israel Deaconess Medical Center (BIDMC) have found that VEGF is a key biomarker for sepsis – a discovery that could lead to a treatment for sepsis - a post infection life-threatening condition. 

     On the market now, two drugs are doing an excellent job treating devastating diseases. Macugen, developed by OSI Pharmaceuticals (OSIP) and marketed with Pfizer for the treatment of all types of neovascular age-related macular degeneration (wet AMD or neovascular AMD), a cause of blindness and Avastin developed by Genentech to treat lung cancer and possibly many other cancers. There is no doubt that side effects exist. But the targeted diseases are so devastating that these side effects, do not weigh much vs. the benefits, which are saving people from blindness and death.

     Both drugs are great and the firms behind them are also great, but the problem is that those drugs will continue to be in experimentation for the same diseases and other diseases, subjected to successes and setbacks making the analysts as if they are evaluating surgeons performing a very serious and complicated surgery. As they follow the surgery step by step, they would issue alternating negative and positive ratings of the surgeons at the sight of a blood leak or a perfect procedure. (Read the next E-letter).

    Today, we have news coming from Genentech, announcing the resumption of patient recruitment into the international Phase 3 study of Avastin® in combination with chemotherapy in early-stage colon cancer.

GENENTECH (DNA)

    Following a recommendation from an independent Data Safety Monitoring Board (DSMB), Roche decided to resume patient recruitment into AVANT, an international Phase 3 study of Avastin® (bevacizumab), XELOX and FOLFOX chemotherapy regimens in early-stage colon cancer. The DSMB based its recommendation to resume enrollment on a detailed analysis of safety data from the trial. The halt in enrollment was implemented in order to conduct a 60-day safety review for recently recruited patients and assess occurrences of cardiac and unknown deaths in one of the treatment arms. After detailed analysis of safety data, the DSMB concluded that the current safety profile and overall mortality observed in AVANT are consistent with those seen in other early-stage colon cancer trials.

IMPORTANT DETAILS: Recruitment to Resume in Avastin International Phase III Trial (AVANT) in Early-Stage Colon Cancer

Read Prohost comments on the whole subject of VEGF in the next Prohost E-letter. 

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ORPHAN DRUG

HANA BIOSCIENCES (HNAB)

     Hana Biosciences (HNAB) announced that the FDA has granted orphan drug designation for Talotrexin (PT-523) in patients with acute lymphoblastic leukemia (ALL). Talotrexin, a novel non-polyglutamatable antifolate drug, is currently being evaluated in a Phase 1/2 multicenter clinical trial in patients with relapsed or refractory ALL.

READ MORE: Hana Biosciences Receives Orphan Drug Designation for Talotrexin (PT-523), For the Treatment of Acute Lymphoblastic Leukemia

ENHANCING MARKETING CAPABILITY

MEDIMMUNE

     MedImmune (MEDI) announced that Peter S. Greenleaf has joined the management team as senior vice president, marketing and sales. In this position, he is responsible for leading MedImmune's global commercial organization and developing strategies to ensure the successful commercialization of the company's current and future product portfolio. David M. Mott, chief executive officer and president of MedImmune said, “The addition of Peter to our team is the capstone of a series of steps taken to strengthen our commercial organization and to prepare for the opportunities that lie ahead."

    MedImmune has proven to be a marketing genius. (Read Past Prohost Newsletter and E-letter.). Recently, Prudential Financials reiterated MedImmune at overweight with a $45 price target   

EAD MORE: MedImmune Fills Senior Marketing and Sales Post

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