During Friday’s Morning trade, Shares of Onconova Therapeutics, Inc. (NASDAQ:ONTX), skyrocketed 56.06% to $3.09.
Onconova Therapeutics declared the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IV rigosertib as a treatment for higher-risk myelodysplastic syndromes (HR-MDS) after failure of hypomethylating agent (HMA) therapy. Upon clearance, the IND enables Onconova to initiate a randomized, controlled pivotal Phase 3 trial in patients with HR-MDS that have failed preceding HMA therapy.
The pivotal trial, designated 04-30 or “INSPIRE”, will enroll HR-MDS patients under 80 years of age who had progressed on, or failed to respond to, previous treatment with HMAs within the first nine months of initiation of HMA treatment, and had their last dose of HMA therapy within six months preceding to enrollment in the trial. The primary endpoint of this study will be overall survival, and an interim analysis is anticipated. This randomized trial of about 225 patients will be conducted at about 100 sites globally. Enrollment in this trial is predictable to start later this year, though the ability to conduct the trial as planned will require additional financing.
Onconova Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on discovering and developing small molecule drug candidates to treat cancer. The company’s clinical-stage product candidates comprise Rigosertib IV, which is in Phase III clinical trials for patients with higher risk myelodysplastic syndromes (MDS); Rigosertib oral in combination with azacitidine that is in Phase II clinical trials for patients with MDS and acute myelogenous leukemia; and Rigosertib oral, which is in Phase II clinical trials for patients with lower risk MDS.
On other hand, Shares of Prima Biomed Ltd. (NASDAQ:PBMD), skyrocketed 59.99% to $1.60, during its current trading session.
Prima Biomed, declared it will receive an unrevealed clinical milestone payment from its partnershipand licensing agreement with Novartis regardingits Phase I IMP701 LAG-3 antibody. The antibody is being trialled for the treatment of cancer.
Immutep (which Prima Biomed attained in December 2014) and CoStim Pharmaceuticals (which Novartis attained in February 2014) reached a commercial licensing and partnershipagreement in September 2012, under which CoStim obtained a licence to develop and commercialise antagonistic LAG-3 antibodies.
Novartis has full responsibility for the continued development of the antibody program and Prima is eligible to receive further potential development-based milestone payments and royalties on sales following commercialisation of the products.
Prima BioMed Ltd. researches, develops, and commercializes medical biotechnology products in Australia. The company develops immunocellular therapeutic products for the treatment of cancer. Its lead product is CVac, an autologous dendritic cell-based product presently in clinical trials for ovarian and pancreatic cancer patients.
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