MADISON, Wis., Feb. 27, 2017 -- Cellectar Biosciences, Inc. (Nasdaq:CLRB), an oncology-focused clinical stage biotechnology company, today provides an update of its Phase I clinical study of CLR 131 in patients with relapsed or refractory multiple myeloma following the previously announced successful completion of its third cohort and initiation of Cohort 4 at a 31.25 mCi/m2 dose.

 

The objectives of the multi-center, open label, Phase I dose escalation study include the characterization of the safety and tolerability of CLR 131 administered as a single dose, 30-minute infusion in patients with relapsed or refractory multiple myeloma, and the establishment of a recommended efficacious dose for Phase II, both with and without dexamethasone, as well as an assessment of therapeutic activity.

TORONTO, Feb. 24, 2017 -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I)  ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs announced that the Company today received final approval from the U.S. Food and Drug Administration ("FDA") for the Company's abbreviated new drug application ("ANDA") for metformin hydrochloride extended release tablets in the 500 mg and 750 mg strengths.  The Company's newly approved product is a generic equivalent for the corresponding strengths of the branded product Glucophage® XR sold in the United States by Bristol-Myers Squibb.

—Fusidic acid met primary endpoint and secondary efficacy endpoints—

—Fusidic acid well tolerated in the study—

 

CHAPEL HILL, N.C., Feb. 24, 2017 -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives for the acute care and community settings to meet critical medical needs in the treatment of infectious diseases, today announced positive topline results from a phase 3 study of oral fusidic acid in 716 patients with acute bacterial skin and skin structure infections (ABSSSI). Fusidic acid was well tolerated in the study and achieved the primary endpoint, demonstrating non-inferiority (NI) (10% NI margin) of oral fusidic acid compared to oral linezolid for early clinical response (ECR) in the intent to treat (ITT) patient population.

CAMBRIDGE, Mass. --  AVEO Oncology (NASDAQ:AVEO) today announced that its pivotal, Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC), has successfully completed the first safety review by the study’s Safety Monitoring Committee (SMC). The SMC concluded that no safety concern was observed for tivozanib and recommended that the study replace the small number of patients who dropped out prior to starting treatment.

 

As recently announced, the TIVO-3 trial is enrolling substantially ahead of schedule, and with the SMC recommendation to replace early dropouts the Company still expects to complete enrollment in June 2017, ahead of its prior guidance of August 2017. A pre-planned futility analysis of the trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support regulatory approval of tivozanib in the U.S. as first and third line treatment for RCC.