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Amgen (NASDAQ: AMGN)
Amgen (NASDAQ: AMGN | Quote | Chart | News | PowerRating) closed yesterday up 0.35% on over 10.1 million shares traded.
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July 7, 2009 - Amgen (NASDAQ: AMGN | Quote | Chart | News | PowerRating) announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. Superiority was demonstrated for both delaying the time to the first on-study Skeletal Related Events (SREs)(fracture, radiation to bone, surgery to bone, or spinal cord compression) (hazard ratio 0.82, 95 percent CI: 0.71, 0.95), and delaying the time to the first-and-subsequent SREs (hazard ratio 0.77, 95 percent CI: 0.66, 0.89). Both results were statistically significant.
Overall, the incidence of adverse events and serious adverse events was consistent with what has previously been reported for these two agents. Of note, osteonecrosis of the jaw (ONJ), which had not been observed in previously reported Phase 3 studies with denosumab, was seen infrequently in both treatment groups. There was no statistically significant difference in the rate of ONJ between the two treatment arms. Infectious adverse events were balanced between the two treatment arms, as was overall survival and the time to cancer progression.
About the company:
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.
Vical Incorporated (NASDAQ: VICL)
Vical Incorporated (NASDAQ: VICL | Quote | Chart | News | PowerRating) closed yesterday up 7.23% on over 1.7 million shares traded.
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July 8, 2009 - Vical Incorporated (NASDAQ: VICL | Quote | Chart | News | PowerRating) announced today that its TransVax(tm) therapeutic DNA cytomegalovirus (CMV) vaccine provided promising results compared with placebo across a broad range of clinical efficacy endpoints at the four-month interim analysis in an ongoing Phase 2 trial. The trial is evaluating the potential for TransVax(tm) to prevent CMV reactivation in immunosuppressed CMV-seropositive hematopoietic stem cell transplant (HCT) recipients, which could reduce antiviral usage and CMV-associated disease. The interim efficacy data for evaluable subjects, unblinded by treatment groups, also reinforced encouraging immunogenicity data from an initial group of HCT recipients in the trial reported previously in the fourth quarter of 2008. The company expects the trial to be completed in the fourth quarter of 2009, and to have final data available in the first half of 2010.
"These interim results demonstrating efficacy for a DNA vaccine in a highly immunocompromised patient population are excellent news for our technology platform," said Vijay B. Samant, Vical's President and Chief Executive Officer. "This latest development, coupled with the significant progress in our ongoing programs including our Phase 3 Allovectin-7(r) immunotherapy for metastatic melanoma, our Phase 3 angiogenesis programs partnered with sanofi-aventis and AnGes MG, and our successful Phase 1 pandemic influenza vaccine trial, we believe our technology is 'ready for prime time.' While we await final results following completion of this endpoint-defining Phase 2 trial, we can now begin working with CMV and transplant experts on Phase 3 trial design."
About the company:
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs.
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