ANN ARBOR — Synthetic Biologics Inc. (NYSE Amex: SYN), a developer of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses, today reported financial results for the three months ended March 31, and summarized operational highlights.
Operational highlights including hiring the former Medical Officer of Clinical Data Inc., Carol Reed, M.D. to serve as Senior Vice President of Clinical & Regulatory Affairs. Dr. Reed, who led the design and management of two consecutive successful Phase III clinical trials and FDA approval for Viibryd, is responsible for the design and implementation of all aspects of clinical development and clinical trials, as well as regulatory initiatives.
The company also initiated preclinical research for the development of a synthetic DNA-based therapy for pulmonary arterial hypertension, utilizing the UltraVector platform and RheoSwitch Therapeutic System of collaborator, Intrexon Corp.
And it appointed gene therapy veteran, Michael Kaleko, M.D., to serve as scientific director. Dr. Kaleko has worked in the field of gene therapy since its inception in the mid-1980s and has extensive experience developing vector platforms, inducible transcription systems and product candidates in multiple disease areas.
The company also completed enrollment of 164 patients in a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial evaluating the efficacy and safety of proprietary oral formulation of estriol (Trimesta) for the treatment of relapsing-remitting MS in women. It also initiated patient enrollment in a second randomized, double-blind, placebo-controlled Phase II clinical trial of Trimesta for the treatment of cognitive dysfunction in MS. Charitable organizations have pledged to financially support a majority of this new MS clinical trial.
The company also separated the roles of chairman and CEO with the appointment of Jeffrey J. Kraws to serve as independent, non-executive chairman of the Board. Kraws has served on the Board of Directors since January 2006.
In terms of first-quarter expenses, the company posted general and administrative costs of $1.5 mllion in the quarter, up from $1.23 million a year earlier. R&D grew to $386,000 from $231,000. The company’s total loss was $1.2 million, an improvement from $2.2 million a year earlier.
More at www.syntheticbiologics.com.