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Oraxol is an innovative development in the treatment of cancer, in that it is an oral formulation of paclitaxel, a very effective and commonly used chemotherapy treatment for many cancers. The existing marketed form of paclitaxel can only be administered intravenously. It cannot be absorbed orally because it is is excreted by gastrointestinal cells via the P-glycoprotein (P-gp) pump before it can be absorbed.
A PIM designation recognizes Oraxol as a promising and innovative drug based on early clinical data. Drugs recognized with a PIM designation must address life-threatening or seriously debilitating conditions, have a high unmet need and demonstrate a positive benefit-risk balance. The designation is the first of two steps in the Early Access to Medicines Scheme (EAMS). The PIM designation now qualifies
The EAMS program was launched in 2014 by the
“We are pleased that Oraxol has been granted a PIM designation and that the MHRA has recognized the innovation in shifting from IV to oral delivery across paclitaxel-responsive cancers,” stated Dr.
The PIM designation follows the independent Data Safety Monitoring Board’s first interim analysis of the Oraxol 001 Phase III Clinical Trial, where they unanimously recommended continuation of the study and encouraged rapid recruitment toward the scheduled second interim analysis, which
Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery and development of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform and a Global Supply Chain Platform. Athenex’s Oncology Innovation Platform generates clinical candidates through an extensive understanding of kinases, including novel binding sites and human absorption biology, as well as through the application of Athenex’s proprietary research and selection processes in the lab. The Company’s current clinical pipeline is derived from two different platform technologies Athenex calls Orascovery and Src Kinase Inhibition. The Orascovery platform is based on the novel oral P-glycoprotein pump inhibitor molecule HM30181A, through which Athenex is able to facilitate oral absorption of traditional cytotoxics, which Athenex believes may offer improved patient tolerability and efficacy as compared to IV administration of the same cytotoxics. The Orascovery platform was developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi. The Src Kinase Inhibition platform refers to novel small molecule compounds that have multiple mechanisms of action, including the inhibition of the activity of Src Kinase and the inhibition of tubulin polymerization during cell division. Athenex believes the combination of these mechanisms of action provides a broader range of anti-cancer activity as compared to either mechanism of action alone. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. Athenex has offices in Buffalo and Clarence, New York; Cranford, New Jersey; Houston, Texas; Chicago, Illinois; Hong Kong; Taipei, Taiwan and multiple locations in Chongqing,
Forward-Looking Statement Disclaimer/Safe Harbor Statement
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; need to raise additional capital; competition; intellectual property risks; risks relating to doing business in