LA JOLLA, CA--(Marketwired - Jul 14, 2016) - Panther Biotechnology, Inc. (OTC PINK: PBYA) (Panther), a biotechnology company specializing in the development of enhanced therapeutics for the treatment of neoplastic and autoimmune disorders, is pleased to announce today that it has initiated the formal drug development process for its lead compound, Transferrin Doxorubicin (TRF-DOX). In April 2015, Panther entered into a definitive agreement with privately held Faulk Pharmaceuticals, Inc. to acquire Faulk's pharmaceutical technology assets which included TRF-DOX. The transaction provided Panther with a proprietary, multi-nationally patent protected, ligand-drug conjugate technology platform as well as a pipeline of drug product candidates that address unmet medical needs in oncology, autoimmune, antiviral and other disease indications. Panther was particularly interested in the TRF-DOX conjugate as it has shown promising safety and preliminary efficacy in a randomized controlled study of ovarian cancer outside the US.
Panther has executed an agreement with Dr. Patricia D. Williams of IND Directions, LLC in Washington DC to lead all aspects of the drug development process for TRF-DOX including regulatory, preclinical, manufacturing and clinical development activities. Dr. Williams has over 30 years of experience designing and implementing high quality drug development programs for small molecules, biologics, and gene therapies. Dr. Williams has held various positions of increasing responsibilities at major pharmaceutical and biotechnology companies (Bristol-Myers, Eli Lilly, American Cyanamid, Ligand, Biochem Pharma) as well as contract research and consulting organizations (SRA Life Sciences, TherImmune, Gene Logic and Summit Drug Development Services). In addition, Dr. Williams has already worked on TRF-DOX with Faulk Pharmaceuticals in the past. Teams under Dr. Williams' leadership have advanced over 50 small molecules and biologics into clinical development. Under Dr. Williams' leadership, Panther has initiated the preparation of a formal Pre-Investigational New Drug (IND) submission to the US Food and Drug Administration (FDA). This step will result in FDA's input into Panther's Phase 2 clinical plans with TRF-DOX as well as the preclinical and manufacturing data that will support clinical trials with TRF-DOX.
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