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CONTROLLING BLEEDING DURING SURGERY

     Recombinant Human thrombin, rhThrombin, could soon become available for surgeons to help control bleeding during surgery. The only available thrombin in the U.S. today is derived from bovine blood. The FDA accepted Zymogenetics’ (ZGEN) application for approval.

     On September 5, 2006, the results of Phase 3 clinical study of (rhThrombin met the primary endpoint. Treatment with rhThrombin and bovine thrombin resulted in comparable incidence of hemostasis at 10 minutes in the four surgical settings tested.

The rate of antibody formation was 1.5% in response to treatment with rhThrombin, versus 22% for those treated with the bovine thrombin product (p < 0.0001). Of patients in the bovine thrombin group who had pre-existing antibodies to the bovine thrombin product, eight of ten showed a ten-fold or greater increase in antibody levels over baseline measurements. 

In addition to rhThrombin, Zymogenetics’ pipeline comprise atacicept (for autoimmune diseases and B-cell malignancies), IL-21 (for cancer) and PEG-interferon lambda (for hepatitis C)

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PROSTATE CANCER

     GPC Biotech AG (GPCB) has completed the rolling submission of a New Drug Application (NDA) to the FDA for satraplatin for patients with androgen independent (hormone refractory) prostate cancer (HRPC) who have failed prior chemotherapy. The trial enrolled 950 patients and showed highly statistically significant results for prolonging progression-free survival (PFS). 

     In September 2006, positive topline results were announced from a double-blind, randomized Phase 3 trial, the SPARC trial. The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer. The study data show that the results for PFS were highly statistically significant (p<0.00001) using the protocol-specified log-rank test. PFS is the primary endpoint for submission for accelerated approval in the U.S. and also serves as the primary basis for a Marketing Authorization Application in Europe.

The Product: Satraplatin is a member of the platinum family of compounds. Platinum-based drugs are used to treat a wide variety of cancers. While platinum drugs currently on the market require intravenous administration, satraplatin is given as capsules that patients can take at home. Satraplatin has been studied in clinical trials evaluating its in combination treatments for a number of cancer types. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals (SPPI) in 2002. 

     There is a story behind Satraplatin. It involves GPC Biotech AG (GPCB), Spectrum (SPPI), Pharmion (PHRM) and Johnson Matthey PLC, which had licensed the product to Spectrum. Read the story in the upcoming Prohost N-Letter. 

INFLUENZA

     A Phase 3 research results published in the February 15, 2007 issue of The New England Journal of Medicine, demonstrated that children under 5 years of age immunized with FluMist (Influenza Virus Vaccine Live, Intranasal) developed by MedImmune (MEDI) had 55 percent fewer incidences of influenza compared to children who received the flu shot. FluMist has also demonstrated protection against influenza strains that were both matched and mismatched to the vaccine. The study was undertaken to support an extension of the indication of FluMist to include children under the age of 5. The second version of FluMist requires only refrigeration, not freezing like the first-generation version.

    This is good news for the young children and for MedImmune. The hope is that these results will motivate   the insurance companies to reimburse for the vaccine. Young children are vulnerable to the flu virus despite the immunization with the available vaccine shots. FluMist is a new option for protecting those children.

LUNG CANCER

     Studies conducted by Dr. Jerry Shay and collaborators at the University of Texas Southwestern Medical School and published in Cancer Research (2007; 67: 1121-29) demonstrated that GRN163L, developed by Geron (GERN) alters tumor cell adhesion in animal models of lung cancer and prevent metastasis. Based on these and other data, Geron intends to initiate a clinical trial this year in patients with lung cancer.   

     Previous studies demonstrated that GRN163L reduces the tumorigenic potential of a human lung cancer cell line (A549-luc) both in vitro and in vivo (Cancer Research, 2005; 65(17):7866-73). The studies showed that the drug has altered the cells morphologically and functionally. One week to five weeks exposure to GRN163L has reduced signs of malignant transformation, while cells treated with a mismatched control drug were unaffected. In an in vivo model of lung cancer metastasis, multiple doses of GRN163L over a three-week period resulted in significant reduction in tumor progression.

     In the present publication, data demonstrate that the drug’s effects are due to specific structural elements of GRN163L. Analogues to GRN163L (different in the lipid moiety component and the thio-phosphoramidate backbone, or lacked a G-triplet within its sequence) did not elicit similar morphological changes or anti-adhesive properties. A single dose of GRN163L at the time of animal inoculation in the in vivo model of lung cancer metastasis resulted in decreased tumor burden at days 13, 20 and 27.

      These data support the importance of the unique structure of GRN163L to its ability to exert the anti-tumor effects.

      GRN163L is a short chain oligonucleotide that is unique in its resistance to nuclease digestion in blood and tissues and its very high affinity and specificity for telomerase. The molecule has superior cellular and tissue penetration properties due to its proprietary manufacturing chemistry and its 5’ lipid chain. The drug has anti-tumor effects in a wide range of hematological and solid tumor models and appears to be unique in its observed effects on tumor stem cells: the rare, chemotherapy-resistant cancer cells that cause cancer recurrence.

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