Kinex and Zenith Technology to Initiate Clinical Studies of an Oral Form of Paclitaxel (Oraxol) in New Zealand

BUFFALO, N.Y., March 19, 2014 /PRNewswire/ -- Kinex Pharmaceuticals announced today to having received regulatory and ethics approvals to initiate the first clinical study of an oral form of paclitaxel (Oraxol) in Dunedin Hospital in Otago, New Zealand.  This is the first clinical study of Oraxol in New Zealand. Oraxol is also currently in clinical studies conducted in Korea and in the United States of America.

Dr. Rudolf Kwan, Chief Medical Officer of Kinex stated "Kinex is grateful to our colleagues in New Zealand who have been extremely helpful in getting the approvals on time. We are delighted to have a very experienced clinical oncology investigator, Dr. Christopher Jackson, to be principal investigator of the first clinical study of Oraxol in New Zealand. Kinex is also delighted to have the support of our partner, Zenith Technology and Dr. Tak Hung to support this study. This is an important component of our global registration strategy and is complementary to our clinical studies conducted by our partner Hanmi Pharmaceuticals in Korea and clinical studies conducted by Kinex Pharmaceuticals in the United States."

"Paclitaxel is a commonly used intravenous chemotherapy drug that has to be administered by IV drip, meaning patients are tied to weekly visits to hospitals to receive treatment. Patients need to have repeated injections of chemotherapy in an effort to treat their cancer. Intravenous paclitaxel has been widely used in hospitals around the world for more than 20 years. An oral form of paclitaxel will be a major advance for cancer patients. The problem is that paclitaxel cannot be absorbed orally, because the gut "pumps out" the drug.   Kinex has a revolutionary new delivery mechanism that blocks this pump and allows the body to absorb paclitaxel orally. This novel delivery system has been formulated with paclitaxel, to form a brand new cancer therapy – Oraxol.  Many of our patients have to travel many hours each week, have a needle placed in their arm, receive chemo at hospital, and then travel home. Our patients travel from Queenstown, Te Anau, Oamaru, Wanaka, and from all over the lower South Island region. They get paclitaxel weekly, meaning they lose a day a week to chemo. This new drug, if successful, could mean that patients won't have to travel and so can spend more time at home with loved ones, and doing things they want to do rather than being tied to the hospital. I want patients with cancer to have time to spend with their families, not spend their time with me getting chemotherapy at the hospital," commented Dr. Christopher Jackson, Senior Lecturer, Department of Medicine, University of Otago, New Zealand; Clinical Leader for Oncology Research in Dunedin Hospital, New Zealand; and Co-founder of Mercy Cancer Care in Mercy Hospital, Dunedin, New Zealand. Dr. Jackson also commented: "I am excited to see the preliminary clinical data of good oral bioavailability of paclitaxel in Oraxol, and the preclinical data of efficacy and fewer side effects (including no infusion related hypersensitivity, few sensory neuropathy, and less bone marrow suppression). We are honored to be selected as the first clinical site outside the developers' countries to conduct clinical studies with this pioneer cancer treatment."

"Zenith Technology is excited to be a collaborative partner with Kinex Pharmaceuticals on Oraxol. Oraxol has an excellent potential.  Oraxol may pave the way for future consideration of low dose maintenance therapy or metronomic dosing. We are excited that we may be developing the next generation of oral oncology drugs for cancer patients. This study will help us to establish the right dose of Oraxol for patients, and to ensure there are no unexpected effects. We will be carefully measuring the blood levels of Oraxol and comparing these to blood levels of paclitaxel, to ensure that patients don't get over- or under-dosed with this drug. It will be an intensive study for the patients, but has wide implications around the world. We are glad that New Zealand is taking the lead on developing this exciting treatment, which if successful, will benefit New Zealand patients first. The trial is set to open in April and if successful, the drug could be available in the clinic in New Zealand as early as 2016. Kinex Pharmaceuticals has a top notch management team and they have been extremely supportive in helping us to initiate our clinical studies in an expedited way. Zenith Technology is delighted to be part of Kinex Pharmaceuticals' global partnership network," commented Dr. Tak Hung, Managing Director.

Dr. Gwan Sun Lee, Chief Executive Officer of Hanmi Pharmaceutical commented: "Hanmi Pharmaceuticals is excited with the initiation of clinical studies in New Zealand. Our partnership with Kinex Pharmaceuticals is extremely fruitful. In a short period of time, Oraxol is already being developed in different geographic regions with good partners. This is another reflection of the experience of the Kinex management team and also Kinex Pharmaceuticals' global network. Hanmi Pharmaceuticals is grateful to our colleagues in University of Otago and Zenith Technology to lead this effort."

About Oraxol:

Oraxol is one of many compounds that could be developed by Kinex and Hanmi through the Orascovery program.  Orascovery is based on an important platform technology developed by Hanmi Pharmaceuticals using compound HM30181A, a potent and selective P-glycoprotein (PGP) pump inhibitor.   Suppression of the PGP pump allows certain clinically important compounds (such as paclitaxel, irinotecan, and others), which would normally be effluxed back into the gastrointestinal tract and excreted, to enter the bloodstream and become bioavailable through oral administration.  Importantly, HM30181A is a very potent PGP inhibitor that is not systemically absorbed.

SOURCE Kinex Pharmaceuticals