Novagali Pharma, a biopharmaceutical company developing innovative drug delivery systems, has started a Phase I clinical trial in patients with advanced cancer for its oral formulation of the cancer drug paclitaxel.
The study is being conducted at the Netherlands Kancer Institute, Amsterdam, in order to assess patient tolerance and pharmacokinetic properties in patients with cancer.
Paclitaxel is active against a broad range of cancers but generally has to be used in intravenous form and administered once every three weeks. Novagali Pharma has designed a new oral formulation which improves the treatment, limits patient discomfort and eliminates the need for staying at the hospital.
The company has developed a self-micro-emulsifying oily formulation which allows oral administration of the chemotherapy while maintaining efficacy and safety of use.
"Starting clinical trials for a product which enables oral administration of paclitaxel and other taxanes offers a major opportunity to explore new ways of treating cancer," said Jerome Martinez, president and CEO of Novagali Pharma. "The preclinical results have been extremely promising and we are eager to get the first Phase I results, which we expect before the end of the summer."
Dr Florence Binlich, VP development and medical affairs for Novagali, noted that the availability of an oral form of paclitaxel would allow combination with other oral chemotherapies and could help prevent long-term relapse in cancer patients.
Paclitaxel, originally developed and launched as Taxol by Bristol-Myers Squibb, belongs to the taxane class of chemotherapy agents. These drugs have been used for many years in intravenous forms for the treatment of breast and ovarian cancer or non-small cell lung carcinoma (NSCLC).