On October 10, 2017 GT Biopharma Inc. (OTCQB: GTBP) (Euronext Paris: GTBP.PA) reported that the first four patients have completed treatment in their Food and Drug Administration-approved (FDA) Phase 2 clinical trial of its promising cancer therapy, OXS-1550 (Press release, GT Biopharma , OCT 10, 2017, View Source [SID1234539538]). Additional patient enrollment is ongoing.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
GT Biopharma 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 GT Biopharma’s partner, the University of Minnesota’s Masonic Cancer Center. Earlier this year, researchers at the University of Minnesota completed a Phase 1 trial of OXS-1550 to determine the safe highest tolerated dose of the drug. A seamless Phase 2 trial followed and began in April. Topline results of the Phase 2 trial are expected to be released in the first quarter of 2018.
Anthony Cataldo, Executive Chairman of GT Biopharma said, "We are pleased with the progress of our four patients in the Phase 2 trial as we continue to move forward with this promising technology."
Dr. Kathleen Clarence-Smith said, "The product performed well in Phase 1 studies of blood cancers, enrollment in the Phase II study is advancing rapidly, 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 Masonic Cancer Center, helped develop OXS-1550.
"The initiation of Phase 2 patient treatment is a key opportunity to demonstrate the effectiveness of this promising cancer therapy," Dr. Vallera said.
The clinical progress for OXS-1550 brings the company closer to an important alternative to toxic and poorly tolerated chemotherapies and to costly cell therapies, such as those from Kite Pharma, Inc. (KITE), and from Juno Therapeutics (JUNO), for cancer patients.
The news about OXS-1550 follows another major corporate development about GT Biopharma, Inc. with the announcement that it had completed its merger with GTP (Georgetown Translational Pharmaceuticals, Inc.), a move that brought in new management and a class of close-to-market Central Nervous Systems (CNS) products to GT Biopharma.
The inclusion of products and new management can be accessed thru the company’s website (gtbiopharma.com) which highlights several benefits of the acquisition for its shareholders.