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news.US-based developer of cancer therapeutics and vaccines AV Therapeutics has entered into an agreement with DavosPharma to assist in the Good Manufacturing Practices (GMP) synthesis of its lead drug candidate Capridine.
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DavosPharma is expected to complete the manufacturing of the drug in the second quarter of 2014 and is also in the process of preparing its investigational new drug (IND) application for the FDA.
AV Therapeutics intends to initiate its Phase I clinical trial in the fourth quarter of 2014, which will be managed by a consortium of hospitals including Memorial Sloan Kettering Cancer Center.
According to the National Institute of Health (NIH) which funded AV Therapeutics’ research, prostate cancer caused nearly 30,000 deaths in the US in 2013 alone.
The company said that the US Department of Defense also provided research funding.
In the preclinical studies carried out by AV Therapeutics, Capridine has shown to have specific activity towards both hormone dependent and independent prostate cancer and minimal bone marrow toxicity.
If successful, Capridine will be the first of its kind adjuvant chemotherapeutic drug for all stages of prostate cancer, the company said.