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OPAXIO Produces High Rates of Pathologic Complete Remission in Patients with Advanced Esophageal Cancer; Study Paves Way for Potential Registration Trial as Radiation Sensitizer
Date:9/30/2009

ry promising results, as standard platinum, 5-FU, and radiation-based regimens for this disease are accompanied by a high incidence of severe radiation esophagitis, requiring patients to receive nutrition through feeding tubes," said Dr. Safran. "Paclitaxel poliglumex's selective radiation enhancement preclinical profile is being validated by the high rates of pathologic complete remission and low rates of severe regional side effects we have observed in this phase 2 study. Our results justify proceeding to a randomized, controlled trial to definitively prove the impressive clinical benefit we have observed in our experience with this novel bioengineered paclitaxel agent," Dr. Safran added.

"We look forward to discussing with the Food and Drug Administration a potential phase III registration strategy for this indication," said Jack Singer, M.D., Chief Medical Officer at CTI. "This would be the first registration study for a radiation sensitizing agent in this indication."

Concurrent chemotherapy with 50.5 Gy of radiation is the standard pre-surgical therapy for patients with potentially resectable, locally-advanced esophageal cancer. Although the addition of chemotherapy to radiation is beneficial, the cure rate for esophageal cancer is low. Standard neoadjuvant treatment for esophageal cancer uses a regimen of cisplatin, and fluorouracil (5-FU) chemotherapy with concurrent radiation, which is a regimen associated with a high incidence of Grade 3-4 toxicity to the upper gastrointestinal track necessitating prophylactic insertion of feeding tubes. Published preclinical studies have demonstrated that, unlike standard paclitaxel and other chemotherapeutic agents that enhance radiation killing by a factor of 1.5 to 2.0, OPAXIO increases tumor specific radiation cell kill by a factor of 7.2 to 8.4-fold (Milas Luka et al, Poly(L-glutamic acid)-paclitaxel conjugate is a potent enhancer of tumor radiocurability, Int'l J. Radiat. Oncol. Biol. Ph
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SOURCE Cell Therapeutics, Inc.
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