On July 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 reported that it has initiated the formal drug development process for its lead compound, Transferrin Doxorubicin (TRF-DOX) (Press release, Panther Biotechnology, JUL 14, 2016, View Source [SID1234517416]). 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.

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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 II clinical plans with TRF-DOX as well as the preclinical and manufacturing data that will support clinical trials with TRF-DOX.

"We are very excited to work with Dr. Williams to initiate clinical development of the Faulk Pharmaceutical technology, which we see as complementary to our efforts to develop and commercialize innovative pharmaceutical approaches for the treatment of cancer. Not only does Dr. Williams provide enormous experience, her previous work on the TRF-DOX will be invaluable to our efforts," stated Evan Levine, Chief Executive Officer of Panther. "The goal of this next phase is to present a clinical plan to the FDA that has the opportunity to generate a statistical signal over the reference drug and progress Transferrin Doxorubicin towards commercialization. We will continue to inform the public as critical milestones are achieved."

TRF-DOX is a combination of the iron-binding glycoprotein, transferrin, and Doxorubicin resulting in targeted delivery to tumors with the reduction of serious side effects. TRF-DOX leverages the targeting ability of the plasma glycoprotein transferrin to deliver a powerful chemotherapeutic payload to cancerous cells which have elevated levels of transferrin receptors. In vitro assays demonstrate growth inhibition of cancer cells that are resistant to other chemotherapies including Doxorubicin itself. Cytotoxicity studies demonstrate that a doxorubicin dose reduction of ten to one hundred-fold kills all cancer cells in multiple cancer types. In vivo studies demonstrate that TRF-DOX selectively binds tumors, inhibits tumor growth better than unmodified Doxorubicin, and increases survival. This improved therapeutic index suggests that further improvements in efficacy without added toxicity can be achieved.