On April 18, 2019 Oxis International Inc. (OTCQB: OXIS and Euronext Paris OXI.PA) reported that the first patient has begun treatment in a Food and Drug Administration-approved Phase 2 clinical trial of its promising cancer therapy, OXS-1550 (Press release, OXIS International, APR 18, 2017, View Source [SID1234539559]).
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Oxis Biotech, a wholly owned subsidiary of Oxis International, owns the worldwide rights to commercialize OXS-1550. The targeted immuno-oncology company is focused on novel antibody constructs that provide alternative treatments to cancer patients for whom existing therapies have failed.
The Phase 2 clinical trial is being conducted with Oxis’ partner, the University of Minnesota’s Masonic Cancer Center. Researchers at the University of Minnesota recently completed a Phase 1 trial of OXS-1550. The Phase 1 portion of the trial involved a safety review to determine the safe and effective dose of the drug.
Anthony Cataldo, Chairman and Chief Executive Officer of Oxis, said the initiation of Phase 2 patient treatment is a key step for the company and a milestone for the promising technology.
"The initiation of Phase 2 patient treatment of OXS-1550 brings us one step closer in our company’s effort to provide a promising alternative to existing technology," Mr. Cataldo said. "The product performed well in Phase 1 studies of blood cancers and we look forward to providing a targeted immunotherapy product that has the capability of treating a number of different liquid tumors." OXS-1550 is an ADC (Antibody Drug Conjugate) drug. ADCs, such as ADCETRIS (brentuximab vedotin) from Seattle Genetics (SGEN), a first-in-class FDA approved antibody-drug conjugate, have paved the way for this type of next generation platform 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 while minimizing damage to normal tissues.
Dr. Daniel Vallera, director of the section on Molecular Cancer Therapeutics at the University of Minnesota Cancer Center, helped develop OXS-1550. He said, "The initiation of Phase 2 patient treatment is a key opportunity to demonstrate the effectiveness of this promising cancer therapy. This brings us one step closer to an important alternative to invasive chemotherapies and costly cell therapies, Kite Pharma, Inc. (KITE), Juno Juno Therapeutics (JUNO), for cancer patients."
The news about OXS-1550 follows other good news about cancer treatments in the Oxis pipeline.
Additionally, on March 23, Oxis announced that it entered into a sponsored research agreement with the University of Minnesota to conduct a toxicity study of its TriKE cancer treatment (OXS-3550), a required step before researchers can apply for a Phase 1 clinical trial with the FDA.
Under the TriKe agreement, Oxis will pay for the university to conduct a study that will determine the optimal dose for OXS-3550.