Orally-absorbed paclitaxel clears Phase I trial
early-stage clinical testing of an oral formulation of paclitaxel,
a widely used cancer drug usually delivered by intravenous
infusion.
The company hopes that its oral version, if successful in additional clinical trials, could simplify paclitaxel treatment and make it possible for patients to receive the drug as outpatients, potentially reducing the overall cost of therapy. Paclitaxel is currently administered as an infusion once every three weeks.
The new formulation - dubbed Nova12005 - could also be combined with other oral chemotherapies and could help prevent long-term relapse in cancer patients, according to Novagali.
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).
The study, lead by Prof Jan Schellens, was carried out at the Netherlands Kancer Institute in Amsterdam. The primary objectives were to assess safety, tolerance and pharmacokinetic properties of Nova12005 in patients with cancer.
"The trial showed that Novagali's oral paclitaxel was safe and well tolerated in patients with advanced cancer," said Dr Florence Binlich, vice president of development and medical affairs at Novagali.
"Thanks to Novagali's proprietary formulation, the drug was quickly absorbed and the bioavailability was high. Repeated oral schedules of Nova12005 should enable appropriate patient exposure and maintenance of therapeutic levels for at least eight hours after administration," she added.
Novagali noted the results - with a particularly challenging, poorly-soluble molecule - suggest that its oral micro-emulsifying technology could be extended to deliver other poorly absorbed drugs by the oral route.
Novagali Pharma is seeking a partner for further development of the product.
