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Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme In Prostate Cancer Models

Halozyme Therapeutics, Inc. (Nasdaq: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, announced the presentation of positive pre-clinical animal efficacy data for its pegylated-rHuPH20 enzyme (PEGPH20) at the American Association for Cancer Research (AACR) Translational Cancer Medicine meeting in Monterey, CA. The study showed that treatment of hormone resistant human prostate cancer in tumor bearing mouse models with intravenous PEGPH20 in combination with the chemotherapeutic drugs, docetaxel (Taxotere(R)) or liposomal doxorubicin (Doxil(R)) resulted in a substantial increase in anti-tumor activity. The docetaxel combination treatment demonstrated significantly enhanced survival compared to treatment with the chemotherapeutic agent alone. The effects of PEGPH20 were selective to prostate tumors producing hyaluronan (HA), consistent with the selective reduction of tumor interstitial fluid pressure (IFP). Treatment with PEGPH20 was well tolerated in non tumor-bearing mice without significant increases in neutropenia (depletion of neutrophils, a type of white blood cell) compared to chemotherapy alone.

"These findings clearly demonstrate the activity of our long acting PEGPH20 enzyme candidate against HA-rich tumors in combination with chemotherapy," said Gregory Frost, PhD, Halozyme's Vice President and Chief Scientific Officer. "By targeting tumors that overproduce the HA matrix component, PEGPH20 may selectively attack tumor interstitial fluid pressure and combined with chemotherapy, reduce tumor burden for a significant number of patients."

Halozyme is continuing its pharmacology, manufacturing and toxicology studies as part of its PEGPH20 development program in oncology. The company is making preparations for a pre-IND meeting with the FDA later this year to seek advice with regard to the design of its first-in-human clinical trial and plans to initiate studies in cancer patients with PEGPH20 during the first half of 2009.

Study Details and Background

This study utilized three widely accepted animal cancer models: xenograft PC3, xenograft Du145luc, and PC3-M-luc bone metastases. For the HA-producing xenograft PC3 model, animals received an intramuscular inoculation with PC3 prostate carcinoma cells in the hind leg in order to generate tumors with high IFP. When tumor volume reached 400-500 mm(3), a high tumor burden, animals were randomized to receive one of four possible treatments: PEGPH20 alone, chemotherapy alone, chemotherapy plus PEGPH20, or placebo. Two chemotherapeutic agents, docetaxel and liposomal doxorubicin, were tested in this model. The non-HA-producing xenograft Du145luc model was utilized in a similar manner with docetaxel. Finally, an HA-producing PC3-M-luc disseminated bone metastasis model was used to test PEGPH20 alone and in combination with docetaxel.

Xenograft PC3 results

-- Tumor volume growth suppressed significantly. Tumor volume growth over time was significantly lower in the PEGPH20 plus docetaxel (p





Halozyme terapeutice Announces pozitive Cu Pegylated Enzyme În cancerul de prostatã modelele - Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme In Prostate Cancer Models - articole medicale engleza - startsanatate