AGEN » Topics » Oncophage (vitespen)

This excerpt taken from the AGEN 8-K filed May 7, 2009.

Oncophage® (vitespen)

  • Updated overall survival results from Antigenics’ Phase 3 study of Oncophage cancer vaccine in nonmetastatic renal cell carcinoma (RCC, the most common type of kidney cancer) will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in May/June 2009. The results will be the first set of follow-up survival data from the patient registry that was initiated after the close of the Phase 3 study to assess patient outcomes over the long-term.
  • The updated survival data are expected to support the company’s Oncophage priorities, namely the ongoing regulatory review of its marketing application by the European Medicines Agency (EMEA) and preparation for commercial launch in Russia.
  • Oncophage was granted orphan drug status for the treatment of glioma (brain cancer) by the U.S. Food and Drug Administration and EMEA in April and March, respectively.
  • In April, a panel of 11 judges assembled at the World Vaccine Congress recognized Oncophage as the best therapeutic vaccine in the period of April 2008 through April 2009.
This excerpt taken from the AGEN 8-K filed Feb 19, 2009.

Oncophage® (vitespen)

  • In November 2008, final results from a Phase 1 investigator-sponsored trial of Oncophage® (vitespen) in recurrent, high-grade glioma were presented at the Society for Neuro-Oncology’s 13th Annual Scientific Meeting. All patients enrolled in the trial had at least one recurrence of brain cancer prior to enrollment and more than half of the patients had more than one recurrence. The Oncophage vaccination following brain tumor resection resulted in overall median survival of approximately 10.5 months, with four patients surviving up to and beyond 12 months with one patient surviving almost 2.5 years. This is compared to a historical median survival of only 6.5 months post surgery. A tumor-specific response was detected after vaccination in all 12 patients.
  • The study also observed a correlation between immune response and overall survival as a result of treatment with Oncophage (n=12; P < .001). The responses were validated by using three separate immune techniques and showed that Oncophage evoked a tumor-specific immune response by producing activated T-cells and natural killer cells that can potentially destroy tumor cells.
  • The Phase 2 portion of the investigator-sponsored study of Oncophage in glioma continues to enroll patients. This study is being supported by the NIH’s Brain Tumor Specialized Programs of Research Excellence (SPORE) program.
  • The European Medicines Agency continues to review the marketing application for Oncophage as an adjuvant treatment in early-stage renal cell carcinoma (RCC; the most common type of kidney cancer).
  • The company continues to make progress toward the commercial launch of Oncophage in Russia. The current key focus of activities in Russia pertains to obtaining government reimbursement for Oncophage in 2009.

This excerpt taken from the AGEN 8-K filed Feb 21, 2008.

Oncophage® (vitespen)

  • In May 2007, at the Annual Meeting of the American Urological Association, Antigenics presented updated results based on its continued data collection from the Phase 3 trial of Oncophage (C-100-12) in patients with nonmetastatic renal cell carcinoma (RCC). These updated results showed that the advantage in the Oncophage arm persisted or improved in comparison with the first analysis of the data. In summary, there was an improvement in recurrence-free survival in the Oncophage arm versus the observation arm of approximately 45 percent (P < 0.01; hazard ratio = 0.55) in the intermediate-risk patient population (n = 362). A trend toward improved overall survival (not statistically significant) was also observed in the intermediate-risk subset.
  • In the second half of 2007, Antigenics met with urology and oncology key opinion leaders from Europe, Russia, Canada and the United States to discuss the updated results from the C-100-12 RCC trial. Overall, the feedback received was very positive, and has encouraged the company to explore regulatory pathways for potential filings of marketing applications in ex-US territories.
  • In June 2007, a marketing authorization application for Oncophage in the intermediate-risk patient population was filed in Russia, where review of the application continues.
  • Pre-launch activities are ongoing to prepare for potential commercialization of Oncophage in Russia in mid-2008.
  • A meeting with the European Medicines Agency (EMEA) is scheduled for the first quarter of 2008. Antigenics plans to discuss with the EMEA the potential filing of a marketing authorization application for conditional authorization of Oncophage.
  • Antigenics has initiated a survival registry to follow approximately 500 patients from the Phase 3 kidney cancer study. Initial data are expected by the end of 2008.
  • Results from a Phase 3 study of Oncophage in metastatic melanoma were recently published in the Journal of Clinical Oncology. The published data showed that patients receiving at least 10 doses of Oncophage had improved median survival of approximately 18.4 months versus patients who received physician's choice of treatment.
  • A white paper written by a group of prominent oncologists, including investigators from Antigenics’ Phase 3 study in kidney cancer and regulatory experts, was recently published in Cancer (Stebbing et al. Cancer. 2008 Jan 18. [Epub ahead of print]). The paper proposes three regulatory mechanisms for accelerated development and approval of therapeutic cancer vaccines in earlier stages of disease.
  • A Phase 2 investigator-sponsored study of Oncophage in recurrent glioma being conducted at the University of California, San Francisco is ongoing. Updated data from the Phase 1 study showed that 11 out of 12 patients exceeded the historical benchmark of 6.5 months of survival from time of recurrence. The Phase 1 study also showed that all 12 treated patients demonstrated a significant and specific immune response after vaccination with Oncophage (P < 0.001).

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