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Kinex Pharmaceuticals Announces Allowance of the Investigational New Drug (IND) application for KX2-391 Ointment by the United States Food and Drug Administration (FDA)
Date:7/24/2014

BUFFALO, N.Y., July 24, 2014 /PRNewswire/ -- Kinex Pharmaceuticals announced the receipt of an allowance by the US FDA for the Company's KX2-391 Ointment for the commencement of a Phase I clinical study in actinic keratosis. This is the Company's third IND to be allowed by the US FDA in the past 12 months.

KX2-391 is a synthetic, orally active and highly selective inhibitor of Src tyrosine kinase signaling and tubulin polymerization. KX2-391 promotes the induction of p53, G2/M arrest of proliferating cell populations and subsequent apoptosis via the stimulation of Caspase-3 and PARP cleavage. Potent inhibition of the growth of human keratinocytes and several melanoma cell lines in vitro suggests the potential clinical activity for actinic keratosis and dermatologic malignancies. In addition, KX2-391 has also been observed to inhibit T cell migration and endothelial tubule formation in vitro, suggesting additional potential therapeutic benefits for skin conditions like psoriasis where pathology is supported by lymphocyte infiltration, inflammation, and/or angiogenesis.

"The encouraging pre-clinical data for KX2-391 Ointment has led us to progress into this clinical study. Actinic keratosis is a pre-malignant condition and fits nicely into our oncology portfolio," said Dr. Rudolf Kwan, Chief Medical Officer of Kinex Pharmaceuticals.

Kinex has licensed out the use of KX2-391 for dermatological indications in the Greater China Territory to a company specializing in pharmaceutical formulations, PharmaEssentia Corp. (Taipei, Taiwan). The scientific leader of this project at PharmaEssentia, Dr. Jer Hsu stated, "I would like to congratulate our team for the successful development of the KX2-391 ointment formulation in collaboration with our excellent collaborative partner, Kinex Pharmaceuticals.  We
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