The Long and Short of GT Biopharma Inc(OTCMKTS:OXISD)


GT Biopharma Inc(OTCMKTS:OXISD) has come down significantly since the 1 for 300 reverse split on August 27 which also saw the Company change their name from OXIS International, Inc. to GT Biopharma Inc.

The extra D will come off shortly and OXISD will be back to trading as OXIS. The stock saw a massive rise last year after the Company received notification from the FDA that they can proceed with their planned combination Phase 1/Phase 2 clinical trial for OXS-1550.

GT Biopharma Inc(OTCMKTS:OXISD) is a biotech company that develops and commercializes innovative drugs of therapeutic molecules including cannabinoids, which are focused on several cancer indications. Oxis address the clinical shortcomings of existing commercial products in related fields. OXIS has formed relationships with some of the world’s leading cannabinoid researchers and institutions to advance its technologies.

The Company has Tony Cataldo behind it who recently said ”As the founder of Lion Biotechnologies, Inc. (LBIO $240 Million market capitalization) I found the same dynamics when creating the nucleus for markets in cell therapies, which brought significant market cap appreciation in exploding biotech sectors. They are now present in the Cannabinoid/Medical Marijuana sector for Oxis Biotech, Inc. to take advantage of.

In September OXIS announced the execution of an exclusive worldwide license agreement to further develop and commercialize DT2219ARL, a novel therapy for the treatment of various human B cell cancers, leukemias and lymphomas.

DT2219ARL is a 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. 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 such as lymphoma.2

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Last year OXIS announced its collaborators at the Masonic Cancer Center, University of Minnesota 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 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 June OXIS said it has begun enrolling patients in a Phase 1/Phase 2 trial of its most promising cancer drug, OXS-1550. The FDA-approved clinical trial is being conducted at the Masonic Cancer Center, University of Minnesota under the watch of Dr. Daniel Vallera, a research scientist who developed the drug and is a member of the Scientific Advisory Board of Oxis’ wholly owned subsidiary, Oxis Biotech Inc.

On September 11 OXISD announced it has made the required payment to license and develop PainBrake, a non-opioid pain medication, to Accu-Break Pharmaceuticals Inc. The payment allows GT Biopharma (OTCQB: OXISD) to begin the clinical development process and the filing of a New Drug Application, the final step for a commercial license from the Food and Drug Administration. The company expects to submit an NDA for PainBrake within 18 months.

PainBrake will use a patented technology – and unique shape – that allows tablets to be easily broken into smaller, precise doses, for maximum dose flexibility and accuracy. The top layer contains the pain-killer and is pre-divided by deep scoring during the manufacturing process to provide exact doses. The bottom layer is drug-free and provides a stable breaking region when splitting the tablet.

PainBrake is a new formulation of a marketed drug for the treatment of neuropathic pain, a chronic condition associated with a variety of causes, including diabetic neuropathy, postherpetic neuralgia, trauma, certain forms of chemotherapy, and multiple sclerosis. In 2009 almost 16 million Americans suffered from chronic neuropathic pain, and the prevalence is expected to increase in the future due to the aging population.

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Currently trading at a $3 million market valuation OXIS has minimal assets or revenues and significant rising short term debt. At the same time OXIS is an exciting story developing in small caps that has just cleaned up the share count with a massive 300 for 1 reverse split. OXIS has many exciting developments including adding 6 new patients in a Phase 1/Phase 2 trial of its most promising cancer drug, OXS-1550. Oxis holds worldwide exclusive rights to develop and commercialize OXS-1550. OXIS has a long way to go with Tony Cataldo as CEO and the Company up listing to the OTCBB. Mr. Cataldo has employed the same strategy he used as founder of LBIO and speculators seem to love the news with OXIS quickly gaining a loyal shareholder base that swears this one goes way higher.We will be updating on OXIS when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with OXIS.

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Disclosure: we hold no position in OXIS either long or short and we have not been compensated for this article.


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