HOUSTON, TX--(Marketwired - Dec 7, 2016) - Panther Biotechnology, Inc. (OTC PINK: PBYA) today announced that it has received positive feedback from the submission presented to the U.S. Food and Drug Administration ("FDA") pursuant to a Pre-IND (Investigational New Drug) meeting with the Division of Oncology Products 1 (DOP1) of the Center for Drug Evaluation and Research (CDER) of the FDA. The purpose of the requested meeting was to obtain FDA's input regarding Panther's plans for the development of TRF-DOX, Panther's novel transferrin-doxorubicin conjugate initially planned for the treatment of platinum-resistant ovarian cancer. In preparation for the meeting, Panther submitted a Pre-IND Package to FDA that described the information Panther intends on submitting in the TRF-DOX IND submission planned in 2017. The IND is the regulatory vehicle that will allow for the initiation of clinical trials with TRF-DOX initially for the treatment of ovarian cancer.
Panther submitted the request to seek guidance on a Phase 2a Open Label Sequential Cohort, Ascending Dose, Blinded, DOXIL controlled Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Multiple Doses of TRF-DOX Administered Intravenously every 4 weeks for up to 12 months to patients with Advanced Platinum-refractory or -resistant Ovarian Cancer. The primary objective will be to evaluate the safety and tolerability of TRF-DOX administered intravenously to subjects with advanced platinum-refractory or resistant ovarian cancer for up to 12 months. Secondary objectives are tumor response rate (complete and partial responses) assessed every 3 months for 12 months following treatment according to Response Evaluation Criteria in Solid Tumors version 1.1. (RESIST) criteria, progression-free survival at 6 and 12 months following first injection of TRF-DOX and overall survival at 6 and 12 months following first injection of TRF-DOX.
FDA reviewed Panther's manufacturing, preclinical pharmacology and toxicology, and clinical plans for TRF-DOX and provided specific feedback. In general, FDA agreed with Panther's plans and offered further recommendations and comments. The manufacturing and nonclinical pharmacology and toxicology plans with TRF-DOX were deemed adequate pending review of actual data by FDA in the IND.
In addition, FDA had input into the design of the Phase 2b clinical trial with TRF-DOX which will be considered in the protocol submitted with the IND.
"This is a significant leap for Panther as we prepare to enter clinical trials in the US and we look forward to getting started," stated Evan Levine, Chief Executive Officer of Panther. "We are extremely pleased and thankful for not only the valuable feedback we received from FDA but also from the productive recommendations to manage TRF-DOX through the next stage of clinical development. Based on earlier encouraging clinical results, we believe we may have a greater opportunity for increasing clinical benefit for patients receiving treatment."
TRF-DOX binds to transferrin receptors on tumor cells, inhibits cancer cell proliferation and causes cell death. TRF-DOX has been shown to exhibit increased cytotoxicity relative to unconjugated doxorubicin toward a variety of cancer cell lines and reduced cytotoxicity to normal cells. In addition to improvements in cytotoxicity and selectivity, TRF-DOX exhibits cytotoxic effects in many multidrug-resistant cells in vitro. Tumor targeting of doxorubicin to transferrin receptors on the cell membranes of tumor cells is intended to improve the therapeutic index of doxorubicin and to reduce the development of doxorubicin resistance.
About Panther Biotechnology Inc.
Panther Biotechnology, Inc. has, for the past two years, been an entity focused on the acquisition and development of enhanced therapeutics for the treatment of neoplastic, autoimmune and antiviral disorders. Panther has recently merged with Brown Technical Media Corp. to diversify its business. Panther will continue its regulatory effort with the goal of seeking a partner or financing for its anticipated phase 2a study of Transferrin Doxorubicin and will also focus its efforts on growing its revenues in the eLearning, standards and codes industries via both organic growth and acquisitions.