Astex and MMRC commence Phase II clinical trial of AT7519 CDK inhibitor in multiple myeloma

Astex Therapeutics, the UK-based biotechnology company developing targeted therapies for oncology and virology, and the Multiple Myeloma Research Consortium (MMRC) announced today the initiation of a Phase II clinical trial of the cyclin-dependent kinase (CDK) inhibitor, AT7519, to treat patients with relapsed or refractory multiple myeloma, an incurable blood cancer. The trial is designed to investigate both single agent and combination activity of AT7519 with bortezomib (Velcade^®).

“We collaborate with industry partners like Astex, so that promising new treatments can be brought to myeloma patients, faster.”

The MMRC's affiliate organization, the Multiple Myeloma Research Foundation (MMRF) has supported the development of AT7519 through its Biotech Investment Award (BIA) program, which provided funding to rapidly test the pre-clinical activity of the compound in multiple myeloma, as well as move it forward into clinical trials. This clinical trial will be conducted through MMRC Member Institution sites and others in the USA.

"Continuing our relationship with Astex in the advancement of AT7519 confirms the effectiveness of our end-to-end drug development model, including identifying promising drug candidates, funding early research and injecting efficiency into the development process," said Kathy Giusti, Founder and CEO of the MMRF and MMRC. "We collaborate with industry partners like Astex, so that promising new treatments can be brought to myeloma patients, faster."

Dr. Noopur Raje (Massachusetts General Hospital Cancer Center, Boston, Massachusetts) is the Principal Investigator. The MMRF-supported work in Dr. Raje's laboratory published in the April issue of Oncogene has demonstrated that AT7519 has significant anti-tumour activity in pre-clinical models of multiple myeloma and supports its further development in this disease.

"The cyclins are over-expressed in the majority of myeloma patients making them an attractive therapeutic target. AT7519, in addition to its potent CDK inhibitory activity works against other kinases relevant to myeloma biology distinguishing it from some of the CDK inhibitors currently in clinical trials and we are very excited to bring this to our patients," said Noopur Raje, Director of the Center for Multiple Myeloma at Massachusetts General Hospital.

AT7519 has already been tested in two international Phase I trials in patients with solid tumours, and the dosing schedule from one of these trials has been chosen for the trial in multiple myeloma patients.

"The MMRF is the world's number-one private funder of multiple myeloma research; we are delighted to continue the collaboration to accelerate the clinical development of our novel compound, AT7519, underlining the quality of drug candidates generated by Astex", said Harren Jhoti, Founder and Chief Executive Officer of Astex. "The funding provided by the MMRF Biotech Investment Award, combined with the MMRC's commitment to quality and track record of speed allows us to conduct this trial of our proprietary CDK inhibitor as a potential new treatment for patients with multiple myeloma."

"Despite significant treatment advances, multiple myeloma remains an incurable disease, with one of the lowest five-year survival rates of any cancer. MMRC's mission is to help bring next-generation therapeutics like AT7519 to patients as quickly as possible," said Susan Kelley, MD, Chief Medical Officer of the MMRC. "We are delighted to be partnered with Astex in support of the clinical development of AT7519."