Oxis Biotech, a wholly-owned subsidiary of Oxis International, Inc. (OTCQB: OXIS) is a biotech company that we introduced to you back in January 2015 that gained approximately 250% just 3 months after we initiated coverage on the company. This emerging biotech, led by an experienced CEO who once before took an OTC listed biotech with a market cap of about $2M to a NASDAQ main listed company now sporting a $325M market cap, has just released potentially game-changing news.
OXIS has just taken a TREMENDOUS step forward by executing an exclusive worldwide license agreement to further develop and commercialize DT2219ARL, a novel therapy for the treatment of various human B cell cancers, leukemia and lymphomas. But this isn’t just any ordinary infant drug. DT2219ARL has already completed an FDA Phase I study with promising results!
The Story Behind the Drug
The University of Minnesota posted an article on their website detailing the extraordinary work done behind the development and success of DT2219ARL. You can read the entire article here: https://give.umn.edu/stories/clinical-trial-triumph
The article details how In June of 2012, University of Minnesota physics professor Cynthia Cattell, Ph.D., discovered she had aggressive B-cell lymphoma, a blood cancer that required immediate, intensive treatment. That treatment—chemotherapy, radiation, and two bone marrow transplants—was brutal, leading Cattell into and out of the hospital for months. Worse, it wasn’t working; her cancer kept growing back. Then, her doctor told her about a Phase I clinical trial underway at the U and asked if she was interested. That clinical trial was that of DT2219ARL.
Fast forward some time and one month after her second round of DT2219ARL, Cattell’s tumors have vanished. And almost a year later, she remains in complete remission.
Dr. Daniel A Vallera, professor at the University of Minnesota Masonic Cancer Center responsible for developing DT2219ARL, got a rare opportunity to come face to face with Cattell, who had gone into complete remission because of a drug he had developed.
Cattell explained, “To meet the person who developed the drug that saved your life? Incredible. I’m so grateful for the work he’s done, and I hope that by participating in the trial, I’ve helped them learn more about the drug and that it will help save other people.”
What This Means for OXIS
We believe this is an absolute game changer for OXIS. This could be the drug that takes OXIS to the next level as a public company. In an interview conducted by the Wolf of Weed Street earlier this year, OXIS CEO Tony Cataldo made it very clear that he believed OXIS would up-list to a major exchange at some point this year. He stated how he was implementing the same strategy and process with OXIS as he did with Lion Biotechnology (LBIO), formerly Genesis Biopharma, the biotech company that went on to up-list to the NASDAQ and reach a recent 52-week high of $15.03. And with this news announcement, we believe OXIS now has enough assets in their pipeline to conduct a large institutional raise with a major investment bank and complete an up-list to a major exchange.
Having a drug with positive Phase I clinical trial results should make OXIS a primary target for several investment funds looking to cash in big on the next major breakthrough in cancer therapy. The biotech industry overall has been the hottest sector in the market this year. Couple that with Cataldo’s past success in biotech and we expect OXIS to have their pick of the litter when it comes time for a major institutional raise to proceed with advanced stage FDA trials and eventually commercializing DT2219ARL.
Cataldo also mentioned how he would only do an up-list with a simultaneous institutional raise because a reverse split would be necessary to qualify for a NASDAQ listing since the current share price is around $0.025 with a market cap of $12.9M. Needless to say we expect the addition of DT2219ARL to drastically increase the market value of OXIS. The current share price also happens to be about the same share price Genesis Biopharma was before conducting a reverse split, becoming Lion Biopharma, and up-listing to the NASDAQ, which was all done with a simultaneous institutional raise. Hmmmm, sound familiar???
Listen to the interview from January 2015 here: https://marijuanastocks.com/wolfofweedst-interviews-oxis-ceo-tony-cataldo/
As a company, OXIS has been relatively quiet lately issuing just a couple press releases with no real major announcements and now we know why. Cataldo has been hard at work to land the exclusive worldwide rights to DT2219ARL. In the press release, Cataldo stated how several other major biotech companies were interested in acquiring DT2219ARL. He went on to say, “This cancer therapy along with our existing platform, puts us in the forefront of next generation therapy alongside companies like Amgen Biologics (AMGN) and Seattle Genetics, Inc. (SGEN).” AMGN and SGEN trade at $147 and $40 a share with market caps of $111.4B and $5B respectively.
Dr. Daniel A Vallera said, “We are very excited to continue this work with Oxis Biotech.” He continued, “A stellar commercialization partner is critical at this juncture since our FDA trial is scheduled to resume with a superior dose scheduling involving multiple cycles of therapy. We expect even better responses with more aggressive treatment and need to move forward quickly.”
The FDA Phase I Study
Twenty-five patients with advanced B-cell lymphoid malignancies expressing CD19 and/or CD22 were enrolled in a clinical study to evaluate DT2219ARL in a phase 1 FDA study. Patients were enrolled that had previous failed chemotherapy, immunotherapy, and/or hematopoietic (bone marrow or stem cell) transplantation. Patients received a single course of DT2219ARL according to study rules. Adverse events were successfully managed and included weight gain, low albumin, transaminitis, and fever were transient grade 1–2 and occurred in patients at the higher doses tested (³40µg/kg/day). Durable objective responses occurred in 2 patients at these higher doses. A complete response occurred in the only patient given a second cycle of therapy that had a 70% cancer reduction after the first cycle of therapy… The patient has been in remission for a year now. Correlative studies showed a surprisingly low incidence of neutralizing antibody (30%) production that could be related to the drug’s ability to suppress antibody responses. For further information about the clinical trial, see Bachanova, V., et. al., Clin Cancer Res; 21(6) March 15, 2015.
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