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Protox to collaborate with FDA in cancer study
2008-04-30 05:16 PT - News Release
Mr. James Beesley reports
PROTOX ANNOUNCES COLLABORATION WITH FDA
Protox Therapeutics Inc. has entered into a collaboration with the Unitec States Food and Drug Administration (FDA) under the terms of a co-operative research and development agreement (CRADA). The collaborative research and development program will be conducted by the principal investigators Dr. Sam Denmeade, MD, chief scientific officer of Protox, and Dr. Raj Puri, MD, PhD, director, division of cellular and gene therapies, Center for Biologics Evaluation and Research at the FDA.
Dr. Puri is a pioneer in the research of interleukin-4 receptors as a potential drug target in cancer and has published extensively in this area. The collaboration will focus on characterizing interleukin-4 receptors on various human tumours, determining the mechanism of up regulation of these receptors, developing assays and animal models to evaluate the safety and efficacy of interleukin-4 receptor-directed therapeutic agents, such as PXR321, and using laboratory analyses to assess the clinical potential of PRX321, either as a monotherapy or in combination with other therapeutic agents. In addition, novel compounds targeting interleukin-4 receptors will be engineered and tested. Under the terms of the CRADA, Protox has an exclusive option to license any future inventions developed under the research program.
Dr. Puri and colleagues reported new findings for PRX321 in Cancer Research, Volume 67(20):9903-9912. In this publication, PRX321, when combined with gemcitabine, a chemotherapeutic agent currently used to treat advanced pancreatic cancer, was shown to have a synergistic anti-tumour effect both in vitro and in a clinically relevant mouse model of advanced pancreatic cancer. Specifically, those mice treated with a combination of PRX321 and gemcitabine showed a significant decrease in tumour burden and improved survival compared with treatment with either PRX321 or gemcitabine alone. This study demonstrates for the first time the potential of combining PRX321 with a chemotherapeutic agent for treating patients with pancreatic cancer.
"We are very excited to be collaborating with Dr. Puri and his colleagues at the FDA," said Dr. Sam Denmeade. "Dr. Puri, as a co-inventor of PRX321, has been actively involved in the discovery and subsequent development of PRX321. This collaboration will support our upcoming primary brain cancer clinical trial, as well as serve to demonstrate the full potential of PRX321 as a selective and potent therapeutic targeting a large number of tumours that overexpress interleukin-4 receptors."
About PRX321
PRX321 is a novel targeted protein in which a cytokine, interleukin-4 (IL-4), is linked to a Pseudomonas exotoxin, a potent substance that can destroy cancer cells. The IL-4 portion of the fusion protein binds to IL-4 receptors found on the surface of various types of cancer cells. The drug subsequently enters the target cell where the toxin component causes cell death by inhibiting protein synthesis. PRX321 is in clinical development for the treatment of primary brain cancer. Results from a phase 2a clinical trial completed in patients with recurrent and progressive glioblastoma multiforme showed potent anti-tumour effects without drug-related systemic toxicity in the majority of patients. PRX321 has also been studied in a completed phase 1 trial in which patients with recurrent, unresponsive metastatic renal cell and non-small-cell lung carcinomas were treated. In addition, PRX321 has shown promising preclinical results in a number of cancers overexpressing IL-4 receptors including pancreatic, ovarian, breast, head and neck, melanoma, prostate and blood cancers such as chronic lymphocytic leukemia (CLL), and Hodgkin's lymphoma. Protox has an exclusive worldwide licence to issued patents covering PRX321.
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