Diffusion Pharmaceuticals LLC Announces Strategic Alliance to Develop New Cancer Therapies
Charlottesville, VA — March 1, 2005 — Diffusion Pharmaceuticals LLC, a company that discovers and develops novel small-molecule therapeutics, today announced that it has reached an agreement with the New Approaches to Brain Tumor Therapy CNS Consortium (NABTT) for a comprehensive clinical trials program to test Diffusion’s lead drug candidate, trans sodium crocetinate (TSC), as a radiation sensitizer in the treatment of cancerous tumors. NABTT, an alliance of ten leading hospitals dedicated to improving the outcome for adults with primary brain tumors, is funded by the National Cancer Institute. Medical experts believe that TSC’s oxygen-enhancing ability may be useful in cancer treatment by increasing the response of cancerous tumors to radiation therapy.
Under the agreement, phase I and II clinical trials will be conducted by NABTT in two different patient populations (“recurrent” and “initially diagnosed” brain tumors) beginning in early 2006. Diffusion Pharmaceuticals also plans clinical trials for TSC in hemorrhagic shock, with a focus on the treatment of wounded soldiers suffering from severe blood loss on the battlefield.
“TSC’s novel mechanism of action provides a whole new approach to radiation therapy,” said Dr. Stuart Grossman, Johns Hopkins Director of Clinical and Laboratory Neuro-Oncology Programs and NABTT Project Leader. “We are excited by its prospects and intend to start clinical trials in patients with primary brain tumors as soon as possible.”
David Kalergis, JD/MBA, Diffusion’s Chief Executive Officer, commented, “FDA approval to begin human testing is expected in early 2006; we’ll be working with NABTT to begin human testing immediately thereafter. The NABTT collaboration should speed TSC’s overall drug-development program for TSC – including our military hemorrhagic shock program – by showing proof of TSC’s ability to safely enhance tissue oxygenation in people. Following this, we want to partner with major companies to develop our new drugs for other unmet medical needs including stroke, cardiovascular disease and severe respiratory conditions.”
About NABTT
NABTT is funded by the National Cancer Institute to conduct phase I and II clinical evaluations of promising new treatment strategies for primary malignancies of the central nervous system. From its central office at Johns Hopkins, the Consortium combines and focuses the experience, resources, and capabilities of ten outstanding medical institutions on primary brain tumors. These institutions have (1) a large number of adult patients with primary brain tumors, (2) expert multidisciplinary clinical teams caring for these patients, (3) extensive clinical and laboratory resources, (4) ongoing high quality, clinically relevant, peer-reviewed and NIH funded clinical and laboratory brain tumor research projects, (5) nationally recognized expertise in oncology, pharmacology, new drug development, phase I and II clinical trials, neurosurgery, and neuropathology, (6) extensive expertise in biostatistics, data management, and the coordination of multi-institutional studies, and (7) exceptional reputations for excellence in clinical care and research. The Consortium adds to these strengths with a well-defined and smoothly functioning organizational structure, and emphasis on clinical trial design, protocol development, quality control, study monitoring, and data management and analysis. For more information, visit www.nabtt.org.
About Diffusion Pharmaceuticals
Diffusion Pharmaceuticals LLC is a drug discovery and development company that owns a platform technology of patented small molecule therapeutics targeted at the treatment of serious medical conditions by increasing tissue oxygenation. Human clinical trials for the Company’s lead molecule trans sodium crocetinate (TSC) are expected to begin in 2006 for hemorrhagic shock and as an adjunct to radiation therapy in the treatment of primary brain tumors. The company’s pipeline drugs, known as trans bipolar carotenoid or TBC molecules, are currently in the pre-clinical stage for the treatment of severe blood loss, brain trauma, ischemic stroke, myocardial infarction, and other conditions characterized by oxygen deprivation at the cellular level. Diffusion Pharmaceuticals, which is privately held, is located in Charlottesville, Virginia, an emerging biotech and drug-development center. For more information, visit www.diffusionpharma.com.
