CHARLOTTESVILLE, Va.?(BUSINESS WIRE)?
Diffusion Pharmaceuticals LLC, a biotechnology company focused on
innovative cancer treatments, today announced that it has successfully
completed the first cohort in a Phase I/II clinical trial testing its
lead compound trans sodium crocetinate (TSC) in newly diagnosed
primary brain cancer patients. All patients in this cohort were treated
at the University of Virginia Medical Center in Charlottesville,
Virginia. Eleven more institutions have been opened for the second
cohort, which has begun enrolling patients. An additional eight
institutions will be initiated during the third quarter of 2012, for a
total of 20 institutions to enroll 59 patients in the study by the first
quarter of 2013.
Patients enrolled in the first cohort were?treated with TSC for three
doses a week over three weeks during radiation therapy. TSC was dosed in
conjunction with the existing standard of care (radiation and
chemotherapy) for newly diagnosed primary brain cancer, also known as
glioblastoma multiforme or GBM. An independent Safety Monitoring
Committee met on July 17, 2012, and authorized enrollment to begin in
Cohort 2 after determining that no dose-limiting toxicities had occurred
and that TSC was well-tolerated in these patients.
?The recommendation from the independent Safety Monitoring Committee
confirms the excellent clinical safety profile seen previously in TSC,?
said David G. Kalergis, Diffusion Pharmaceuticals? CEO. ?Enrollment of
the second cohort is already underway, and we are on schedule to meet
our goal of full study enrollment and efficacy evaluations during the
next year.?
Dr. James Larner and Dr. Jason Sheehan of the University of Virginia
Medical Center are Study Co-Chairs for this trial. A listing of all
trial sites, including contact information, may be viewed online at http://www.clinicaltrials.gov.
About Diffusion Pharmaceuticals
Diffusion Pharmaceuticals is a clinical-stage company developing
first-in-class drugs which target the numerous unmet medical needs
characterized by oxygen deprivation (hypoxia) at the cellular level.
These proprietary small molecules work by a novel mechanism of action
that enhances the diffusion of oxygen selectively to hypoxic tissue.
Potential breakthrough clinical applications include oncology,
cardiovascular diseases, stroke and respiratory disorders. Diffusion?s
lead program is the use of TSC in the treatment of solid cancerous
tumors. Published studies demonstrate a tripling of survival and
superior tumor control when TSC is combined with radiation and
chemotherapy in animal models of primary brain cancer. A phase I/II
clinical study of TSC dosed concomitantly with radiation and
chemotherapy in newly diagnosed GBM patients is currently enrolling
patients. Diffusion Pharmaceuticals, which is privately held, is located
in Charlottesville, Virginia. For more information, visit www.diffusionpharma.com.
Article source: http://finance.yahoo.com/news/diffusion-pharmaceuticals-successfully-completes-first-180000879.html
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