On April 4, 2017 Oxis International Inc. (OTCQB: OXIS and Euronext Paris OXI.PA) reported that the Food and Drug Administration has cleared the way for the Company’s wholly owned subsidiary, Oxis Biotech Inc., to begin a FDA Phase 2 clinical trial for its promising cancer treatment OXS-1550 in the treatment of lymphoma and leukemia (Press release, OXIS International, APR 4, 2017, View Source [SID1234539558]).
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Oxis Biotech, a targeted immuno-oncology company focused on novel antibody constructs, owns the worldwide rights to commercialize OXS-1550.
The FDA Phase 2 clinical trial will be conducted with Oxis’ partner, the University of Minnesota’s Masonic Cancer Center. Researchers at the University of Minnesota recently completed a FDA Phase 1 trial of OXS-1550. The Phase 1 portion of the trial completed a safety review to determine the safe and effective dose of the drug.
OXS-1550 uses a proprietary immunoconjugate platform technology, as a treatment for leukemia and other blood-born cancers. What sets OXS-1550 (DT2219ARL) apart from other treatments, such as chemotherapy, is that it is designed to specifically target and kill cancer cells minimizing damage to normal tissues.
"This milestone represents a major step forward for our technology. The product has performed well in its phase 1 studies in blood cancers and we look forward to positive results in Phase 2," said Anthony Cataldo, Chairman and Chief Executive Officer of Oxis. "This next generation drug has the possibility of treating a number of different liquid tumors and, if successful, will drastically change the paradigm now being developed that relies on highly expensive autologous cell therapies such as presented by Kite Pharma, Inc. (KITE), Juno Therapeutics, Inc. (JUNO) and other autologous or semi-autologous and adoptive therapy approaches currently under development."
Dr. Daniel Vallera, director of the section on Molecular Cancer Therapeutics at the University of Minnesota Cancer Center, lead developer of OXS-1550 said, "The FDA’s clearance for Phase 2 is an important step forward for this cancer treatment."
Dr. Vallera has spent 35 years with the University of Minnesota’s cancer center, where he oversees a laboratory specializing in the development of biological recombinant drugs focusing on bispecific antibody therapies that directly deliver toxic signals to cancer cells.
"We are excited to see this new therapy proceed to Phase 2," Dr. Vallera said. "So many of these patients presenting with chemotherapy refractory cancer have few, if any, alternative choices for cancer treatment."