An adjuvant approach to Cancer therapy:
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Advantagene has active clinical programs in prostate, brain and pancreatic cancer in various centers throughout the U.S.
ProstAtak: Prostate
Advantagene completed a non-randomized, historically controlled 71-patient phase II study in newly diagnosed prostate cancer patients receiving radiation therapy. The results showed a 3-4 fold decrease in tumor recurrence, compared to concurrent studies: from >30% recurrence to <10%, after a median follow up of 6 years. Based on these promising results, the FDA granted Fast Track status for ProstAtak in newly diagnosed prostate cancer. A randomized controlled trial will be launched in 2010 with expected results in four years.
GliaAtak: Malignant Glioma
After completing a Phase I dose escalation study of AdV-tk as a monotherapy in recurrent malignant gliomas Advantagene launched a Phase Ib trial in newly diagnosed disease in combination with surgery, radiation and temozolomide. This was recently completed with no dose limiting toxicity. Patients received radiation therapy without significant delays or interruptions and temozolomide could be administered to all patients. A second arm, for unresectable disease, is open and being evaluated independently. For the resectable population, a Phase IIa study is underway to expand the safety evaluation at the maximum Phase Ib dose. A European group reported an 81% increase in average survival from a small, randomized Phase II study using a similar vector and design (from 39 to 70.6 weeks). The FDA has granted orphan status for GliAtak. A randomized pivotal trial design for a one-year survival primary end-point is planned for launch in late 2010.
PancAtak: Pancreatic Cancer
In pancreatic cancer a Phase I dose escalation study as an up front adjuvant to standard of care, with one arm for resectable disease and another for locally advanced disease, is open for enrollment. As of January 2010, three patients have been treated with no significant drug related toxicities.
Prostate cancer affects a large number of patients – around 230,000 new diagnoses/year and 70,000 recurrences in the U.S. alone. Advantagene’s ProstAtak™ is designed to delay and decrease the rate of recurrence and make the disease free survival period longer than the patients’ overall life expectancy. Clinical Phase II data results were a three to five-fold decrease in overall treatment failure rate in intermediate risk patients and a fourfold decrease in histopathological tumor presence @ 24 months
With approximately 32,000 new cases annually in the U.S., a phase I/II trial has also been developed in pancreatic cancer combining Advantagene’s PancAtak™ with standard of care chemoradiation and surgery. With Pancreatic cancer we can assess for short-term endpoints evaluating median survival, reduction in tumor size and an increased resectability rate.
With approximately 18,000 new cases annually in the U.S., Advantagene’s GliaAtak™ is for treatment of primary brain tumors. Current therapies for this disease, including surgery, radiation and chemotherapy, are essentially palliative. There is a desperate need for additional tools for treatment and even small improvements in survival or quality of life provide a potentially valuable product for patients with malignant brain tumors.
This unique therapy works with the patient's current standard of care and promotes an anti-tumor immune response, leading to increased tumor cell death, and a reduction in recurrence in our clinical trials. Advantagene is currently using the technology in trials for prostate cancer, brain cancer and pancreatic cancer to decrease the incidence of tumor recurrence (or metastasis) after a patient's initial treatment of cancer..
