$OXIS Receive FDA Allowance To Proceed With OXS-1550

 Oxis Biotech, Inc. (OXIS), a wholly owned subsidiary of Oxis International, Inc. [OTC: OXIS] and [Euronext Paris: OXI.PA] announced today its collaborators at the University of Minnesota Masonic Cancer Center received notification from the U.S. Food and Drug Administration (FDA) that they can proceed with their planned combination Phase 1/Phase 2 clinical trial for OXS-1550.  Oxis holds worldwide exclusive rights to develop and commercialize OXS-1550, a novel therapy for the treatment of leukemia and lymphoma.

OXS-1550 is a bispecific scFv recombinant fusion protein composed of the variable regions of the heavy and light chains of anti-CD19 and anti-CD22 antibodies and a modified form of diphtheria toxin as its cytotoxic drug payload.  CD19 is a membrane glycoprotein present on the surface of all stages of B lymphocyte development, and is also expressed on most B-cell mature lymphoma cells and leukemia cells.^[1]  CD22 is a glycoprotein expressed on B-lineage lymphoid precursors, including precursor B acute lymphoblastic leukemia, and often is co-expressed with CD19 on mature B-cell malignancies.^[2]  Dual targeting also has the advantage of delivering twice the therapy to cells that are both CD19 and CD22 expressers.

OXS-1550 targets cancer cells expressing the CD19 receptor or CD22 receptor or both receptors.  When OXS-1550 binds to cancer cells, they internalize OXS-1550 and are killed due to the action of drug’s cytotoxic payload.  OXS-1550 has demonstrated success in early human clinical trials in patients with B-cell lymphoma or leukemia.

In a Phase 1 clinical trial conducted by Oxis’ collaborators at the University of Minnesota Masonic Cancer Center, 25 patients with chemotherapy refractive B-cell lymphoid malignancies expressing CD19 and/or CD22 were enrolled.  Patients with advanced drug refractory disease failed three prior types of chemotherapy, and eight failed hematopoietic transplantation. All patients received a single course of OXS-1550 consisting of 4 daily injections with no other treatment. Therapeutic dosing was achieved in the final 10 patients treated at the highest dose levels. Of these 10 patients, one patient with chronic lymphocytic leukemia achieved a partial response and a marginal zone lymphoma patient achieved a complete response that has now lasted more than a year and a half. The continued trial is designed to complete the Phase 1 trial, determine the MTD, and then transition into a Phase 2 study permitting added cycles of treatment mandatory for durable responses.  A 2015 publication in the peer-reviewed journalClinical Cancer Research; 21(6) March 15, 2015 reported that the most common toxicity in the last 10 patients were peripheral edema and hypoalbuminemia. These toxicities were managed and reversible after a week.

Dr. Daniel A. Vallera, developer of the drug, when asked to comment states, “We are looking forward to commencing the combination Phase 1/Phase 2 study which we feel will clearly show the advantage of multiple cycle drug therapy. We can now give twice the number of drug injections as before, and when responses are observed, we are now cleared by the FDA to give additional cycles.  This drug is a powerful alternative to chemotherapy since many patients fail chemotherapy or reach the toxic limits of their chemotherapy. It is urgently needed in the clinic.”

“We are pleased that the FDA has now given us clearance to move forward with our Phase 1/2 clinical trial of OXS-1550,” said Anthony J. Cataldo, Chairman and CEO of Oxis Biotech.  “We believe OXS-1550 holds great promise and represents a major milestone for Oxis,” Mr. Cataldo further added.

About Oxis Biotech, Inc.

Oxis Biotech is an immuno-oncology focused company developing innovative drugs focused on the treatment of cancer and other unmet medical needs.  OXIS’ lead drug candidate, OXS-1550 (DT2219ARL), is a novel bispecific scFv recombinant fusion protein-drug conjugate composed of the variable regions of the heavy and light chains of anti-CD19 and anti-CD22 antibodies and a modified form of diphtheria toxin as its cytotoxic drug payload.  OXS-1550 targets cancer cells expressing the CD19 receptor or CD22 receptor or both receptors.  When OXS-2175 binds to cancer cells, the cancer cells internalize the drug and are killed due to the action of the drug’s cytotoxic payload.  OXS-1550 has demonstrated success in early human clinical trials in patients with relapsed/refractory B-cell lymphoma or leukemia.  OXS-4235 is a small molecule therapeutic candidate targeting the treatment of multiple myeloma and associated osteolytic lesions.  In in vitro and in vivo models of multiple myeloma and osteoporosis, OXS-4235 demonstrated the ability to kill multiple myeloma cells, and decrease osteolytic lesions in bone.  OXIS’ lead drug candidate, OXS-2175, is a small molecule therapeutic candidate targeting the treatment of triple-negative breast cancer (TNBC).  In in vitro and in vivo models of TNBC, OXS-2175 demonstrated the ability to inhibit metastasis.  For more information about Oxis Biotech and it product pipeline, please visit https://www.oxis.com.

Forward-Looking Statements

Except for historical information contained herein, the statements in this release are forward-looking and made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently unreliable and actual results may differ materially.  Examples of forward-looking statements in this news release include statements regarding the payment of dividends, marketing and distribution plans, development activities and anticipated operating results.  Factors which could cause actual results to differ materially from these forward-looking statements include such factors as the Company’s ability to accomplish its business initiatives, significant fluctuations in marketing expenses and ability to achieve and expand significant levels of revenues, or recognize net income, from the sale of its products and services, as well as the introduction of competing products, or management’s ability to attract and maintain qualified personnel necessary for the development and commercialization of its planned products, and other information that may be detailed from time to time in the Company’s filings with the United States Securities and Exchange Commission.  The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

^[1] Scheuermann RH, Racila E., Leuk. Lymphoma (1995) 18:385–97.
^[2] Cesano A, Gayko U., Semin. Oncol. (2003) 30:253–7.