MADISON, Wis., Nov. 15, 2016 -- Cellectar Biosciences, Inc. (CLRB) (the “company”), an oncology-focused, clinical stage biotechnology company, today announced it has selected INC Research (INCR), a leading global Phase I to IV contract research organization, to oversee its NCI-supported Phase II clinical trial of CLR 131 in patients with multiple myeloma and select hematologic malignancies.  The company anticipates that its $2M NCI grant will cover approximately 50 percent of the study’s cost, and the terms of the grant allow Cellectar to pursue an additional $3M for a pivotal Phase III trial of the company’s lead radiotherapeutic compound.

NEWTOWN, Pa., Nov. 14, 2016 -- Onconova Therapeutics, Inc. (ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today provided a corporate update and reported financial results for the third quarter ended September 30, 2016.

 

“Onconova continues to reach important milestones in the development of rigosertib for patients with myelodysplastic syndromes (MDS).  In July, our partner SymBio Pharmaceuticals announced the enrollment of the first patient in Japan for our INSPIRE pivotal trial for rigosertib in 2nd-line higher-risk MDS (HR-MDS). In September, we announced the results of a successful End-of-Phase 2 meeting with the FDA for oral rigosertib in combination with azacitidine for 1st-line HR-MDS patients,” said Ramesh Kumar, Ph.D., President and CEO of Onconova. “We are pleased with the progress of our oral rigosertib development program, as well as the INSPIRE trial that is now running on four continents with more than 150 trial-sites in 15 countries.”

NORWOOD, MA--(November 14, 2016) - Corbus Pharmaceuticals Holdings, Inc. (CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, today announced positive topline results from its Phase 2 study evaluating Resunab ("JBT-101") for the treatment of diffuse cutaneous systemic sclerosis ("systemic sclerosis"). JBT-101 out-performed placebo in the American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score, reaching 33% at week 16, versus 0% for placebo. The higher the CRISS score the greater the improvement; a CRISS score ≥ 20% (CRISS20) can be considered a medically meaningful improvement. The difference in CRISS scores between JBT-101 and placebo groups over the trial period was significant (p = 0.044). Differences in categorical levels of CRISS responses and changes from baseline in the five individual domains of the CRISS score also supported clinical benefit of JBT-101.

SOUTH PLAINFIELD, N.J., Nov. 11, 2016  -- PTC Therapeutics, Inc. (PTCT) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the renewal of the conditional marketing authorization of Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) in ambulatory patients five years and older. In connection with the renewal, the marketing authorization will include a specific obligation to conduct an additional long-term post-authorization trial.

 

"We are pleased with this outcome which took into account all available data for Translarna," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "This decision reflects the benefit that Translarna is having for patients suffering from nonsense mutation Duchenne muscular dystrophy."