HYDERABAD, India--(BUSINESS WIRE)--July 22, 2002--
Carcinogenicity studies reveal tumors in rats and mice. Mechanism not yet known. If mechanism of no human relevance - new trials may be initiated and filing for approval may be delayed by close to two years.
Dr. Reddy's Laboratories today announced that Novo Nordisk has decided to suspend the clinical development of its dual-acting insulin sensitiser Ragaglitazar (DRF 2725).
All current clinical trials involving Ragaglitazar have been stopped and all planned new clinical trials have been postponed, while preliminary data from preclinical studies in rats and mice are being investigated further. Novo Nordisk's decision was taken in response to findings of urine bladder tumours in one mouse and a number of rats treated with Ragaglitazar.
Novo Nordisk will continue other activities in the Ragaglitazar project until it has completed a renewed benefit/risk assessment of Ragaglitazar. This assessment is expected to be ready by the first quarter of 2003.
Mads Krogsgaard Thomsen, Chief Science Officer of Novo Nordisk, said: "The tumours observed may prove to be specific for the rodent species and in that case, they will be of no relevance to humans. However, we have for patient safety reasons decided to take a precautionary approach and stop the ongoing clinical trials while we investigate the preclinical findings in more detail. It is at this point in time not possible to say whether new clinical trials involving Ragaglitazar will be initiated; however, if so, we expect the filing for approval to be delayed by close to two years."
Ragaglitazar (DRF 2725) is a PPAR (peroxisome proliferator-activated receptor) alpha and gamma agonist, which in preclinical and early clinical trials has shown potential to regulate blood glucose and diabetic dyslipidaemia. The compound is out-licensed to Novo Nordisk in March 1997.
About carcinogenicity studies
Preclinical carcinogenicity studies are an integral part of the development of new drugs for chronic use. The purpose of doing preclinical carcinogenicity studies in animals is to investigate in vivo if a new drug has potential of causing tumours after long-time exposure in animals. Due to the complexity of conducting state-of-the-art preclinical carcinogenicity studies, data from such studies do not usually become available until very late in Phase 3 clinical development or just prior to submission of the NDA.
The carcinogenicity studies with Ragaglitazar have been conducted in rats and mice, which are the species most commonly used for such studies... |
