- Development Program Can Support Approval, No New Studies Requested

- NDA Submission by CytRx Being Prepared

- Conference Call on April 19, 2017 at 8:30 AM EDT/ 5:30 AM PDT

 

LOS ANGELES, April 19, 2017 -- CytRx Corporation (NASDAQ: CYTR) today announced the U.S. Food and Drug Administration (FDA) has reached an agreement with CytRx on preparations for a New Drug Application (NDA) submission for aldoxorubicin in soft tissue sarcomas (STS). STS remains a high unmet medical need.

PRINCETON, N.J., April 19, 2017 /-- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that results from its ricin toxin vaccine (RiVax™) development program will be presented at the 20th Annual Conference on Vaccine Research, being held April 24-26 in Bethesda, Md.

 

"Serum Antibody Profiling following Vaccination Reveals a Correlate of Immunity to Ricin Toxin" will be presented by Jennifer Yates, Ph.D., New York State Department of Health, Wadsworth Center and attended by Oreola Donini, Ph.D., Chief Scientific Officer of Soligenix, on April 25 at 2:15 p.m. Eastern time.

Begins Formal Review of Strategic Options

 

SAN DIEGO -- AmpliPhi Biosciences Corporation (NYSE MKT: APHB), a global leader in the development of therapies for drug-resistant bacterial infections using bacteriophage technology, announces that the U.S. Food and Drug Administration (FDA) provided positive feedback on the Company’s previously submitted detailed development proposal to commence a Phase 2 trial with its proprietary bacteriophage cocktail AB-SA01 for the treatment of antibiotic-resistant Staphylococcus aureus (S. aureus) infections in patients with chronic rhinosinusitis (CRS). The FDA’s feedback followed a Type B telephonic meeting held with AmpliPhi on February 21, 2017. In the official minutes from the meeting, the FDA acknowledged that phage therapy is an exciting approach to treatment of multidrug-resistant organisms and expressed a commitment to addressing the unique regulatory challenges that might arise during product development.

BUFFALO, NY--(Apr 17, 2017) -  Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the European Medicines Agency (EMA) has accepted the company's pediatric investigation plan (PIP), paving the way for submission of a Marketing Authorization Application (MAA) for entolimod as a medical radiation countermeasure.

 

As part of the regulatory process for submitting an MAA in the European Union, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. As agreed with the EMA, existing CBLI results, when combined with future nonclinical cell culture experiments and formulation, provide a path toward product labeling for children. The future work to be performed as part of the PIP can be deferred until after an MAA submission.