Panther Biotech (PBYA) Granted FDA Pre-IND Meeting for TRF-DOX

October 24, 2016 7:03 AM EDT
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Panther Biotechnology, Inc. (OTC: PBYA) announced that a Pre-Investigational New Drug (Pre-IND) meeting with the Divison of Oncology Products 1 (DOP1) of the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) has been granted by FDA. The meeting with the Oncology Division of FDA will take the form of written responses to Panther's Pre-IND package and questions regarding the development of TRF-DOX, Panther's novel transferrin-doxorubicin conjugate for the treatment of platinum-resistant ovarian cancer. In preparation for FDA's feedback, Panther is preparing a Pre-IND Package to be submitted to FDA that describes the information Panther intends on submitting in the TRF-DOX IND planned for submission in 2017. The IND is the regulatory vehicle that will permit the initiation of clinical trials with TRF-DOX in the U.S.

FDA will specifically review Panther's manufacturing, preclinical pharmacology and toxicology, and clinical plans for TRF-DOX and provide specific feedback to Panther by the end of the year.

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. Panther is proposing to conduct an open label Phase 2a, multiple ascending dose study to investigate the safety, pharmacokinetics and preliminary efficacy of TRF-DOX in patients with platinum-resistant ovarian cancer.



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