OXIS International Inc (OTCMKTS:OXIS) Is Today's Biotech Focus

OXIS International Inc (OTCMKTS:OXIS) is developing drugs in efforts to treat cancer and the Zika Virus. The company has a robust portfolio of next-generation cancer initiatives – the type the "Moonshot" is focused on. Oxis' lead drug candidate, OXS-1550, is in Phase 1/Phase 2 clinical trial at the University of Minnesota Masonic Cancer Center as a treatment for non-Hodgkins lymphoma and leukemia. OXS-1550 is a bispecific immunotherapy designed to hunt cancer cells and kill them, without damaging healthy cells. Oxis also has other drug candidates: OXS-1750, a treatment for multiple myeloma, and OXS-1850, a treatment for breast cancer.On March 1, Oxis announced that the company had identified small molecule chemical inhibitors that target nonstructural proteins with the potential for blocking Zika virus replication. Lead researcher Dr Sean Xie, professor of pharmacology at the University of Pittsburgh and a member of Oxis' Scientific Advisory Board, used his TargetHunter computer modeling system to break down key proteins the Zika virus needs for replication. That allowed him to identify inhibitors that could block the virus from replicating.Oxis is hopeful that Dr. Xie's findings could help develop a vaccine and treatment for the Zika virus and greatly slow the spread of the disease. The Zika virus, first identified 50 years ago, is spread through mosquito bites and has been linked to an increase in a rare birth defect, making the virus a significant threat to pregnant women. Additionally, there is a concern that the Zika virus can be spread sexually. In January, the World Health Organization designated the Zika virus an international public health emergency. The agency estimated that virus will spread throughout the world and infect some 4 million people by the end of the year.In February, Oxis announced that inventors of OXS-1550 received a Notice of Allowance from the United States Patent and Trademark Office (USPTO). Oxis holds worldwide exclusive rights to develop and commercialize OXS-1550, a novel therapy for the treatment of various human cancers. The patent decision came as OXS-1550 is being evaluated in a new Phase 1/Phase 2 clinical trial. The objective of the Phase 1 study is to identify the Maximum Tolerated Dose (MTD), and the optimized dose and regimen to be used in the Phase 2 study.

Enrollment of patients into the Phase 2 study will begin after the Phase 1 study is completed. The Phase 2 study is a two-stage, two-ARM design. Patients from the Phase 1 study plus an additional 9 patients will be enrolled in stage 1 of the Phase 2 study. If one patient enrolled in the Phase 2, stage 1 part of the study has a positive response, then an additional 8 patients will be enrolled in the Phase 2 stage of the study. At a maximum, up to 29 patients will be enrolled across both the Phase 1 and Phase 2 (stages 1 & 2) studies.

OXS-1550 has demonstrated success in early human clinical trials in patients with relapsed/refractory B-cell lymphoma or leukemia. In an earlier Phase 1 clinical trial, twenty-five patients with mature or precursor B-cell lymphoid malignancies expressing CD19 and/or CD22 were enrolled. When the study allowed for an increase in the dose level (60 mg/kg) in the final 9 patients, durable objective responses occurred in 2 patients; one patient continues to be in complete remission after being administered 2 cycles of OXS-1550.

Oxis Chairman and CEO Anthony Cataldo, the company's founder, has a proven track record in biotech. He is the founder and former Chairman and Chief Executive Officer of Lion Biotechnologies Inc (NASDAQ:LBIO). He led the company from February 2011 until June 2013, using assets licensed from the National Cancer Institute for the treatment of stage four melanoma. Today, Lion has a market capitalization of around $280 million.Currently trading with a market cap of $13 million, OXIS has emerged as an exciting story on the OTC markets with a proven management team and a history of success. In February, OXIS reached an agreement to restructure unregistered debt and equity securities that has already eliminated more than 12 million warrants and further eliminated $14.8 million of notes and all Series H and I Preferred Shares. The restructuring allows OXIS to continue its Phase 1/Phase2 FDA clinical trial of OXS-1550. The company also has its eye on a NASDAQ listing. We will be updating Insider Financial as soon as we know more. For continuing coverage on OXIS, sign up for our free newsletter today and get our next hot stock pick!Disclosure: We have no position in OXIS and have not been compensated for this article.