Tarsa presents meta-analysis showing calcitonin not associated with cancer

Date: Oct-08-2013Tarsa Therapeutics, Inc. has announced that it presented a new meta-analysis showing that salmon calcitonin does not appear to be associated with an increased risk of cancer in postmenopausal women. The meta-analysis was conducted using data derived from approximately 11,000 women in 24 randomized, controlled calcitonin trials that included reporting of adverse events. The meta-analysis yielded an odds ratio close to unity with a narrow bound on the error of estimation, suggesting that calcitonin does not appear to be associated with an increased risk of cancer.

The data were presented in a plenary poster session at the 2013 ASBMR Annual Meeting.1 Tarsa is developing an oral calcitonin tablet for the treatment and prevention of post-menopausal osteoporosis.

In 2012, the European Medicines Agency withdrew calcitonin nasal spray from the market and limited the duration of use of other calcitonin products, due to a purported association with cancer. In early 2013, similar data were the topic of a joint meeting of the FDA's Advisory Committee for Reproductive Health Drugs and its Drug Safety and Risk Management Advisory Committee. At that meeting Tarsa representatives highlighted that:

Despite 30 years of global use, no post-marketing surveillance reports from any regulatory authority have ever linked calcitonin with cancer.

A previous meta-analysis conducted by Novartis2 did not include data from more recent clinical trials of oral calcitonins, including Tarsa's oral calcitonin product.

Given that formal calcitonin carcinogenicity and mutagenicity tests in animals have all been negative and that cancer is biologically diverse, no plausible mechanism has been identified that could explain a putative increased cancer risk.

"There are only a few classes of agents available to treat osteoporosis, and the fact that millions of patients are currently going untreated, or opting out of treatment, underscores the need for more therapeutic choices," noted Dr. David Krause, Chief Medical Officer of Tarsa. "Calcitonin has been shown to have a modest but consistent positive effect on bone mineral density at the lumbar spine, and this more comprehensive meta-analysis confirms our earlier research showing that calcitonin does not appear to be associated with an increased risk of cancer."

At the 2012 ASBMR Annual Meeting, Tarsa presented an analysis that concluded there was no carcinogenicity signal in the two one-year long trials of its oral calcitonin, which enrolled almost 700 women.3

In a Phase III global, randomized, double-blind trial in postmenopausal women with osteoporosis, known as the ORACAL trial, Tarsa's once-daily oral calcitonin demonstrated superiority to both placebo and nasal calcitonin spray in increasing bone mineral density at the lumbar spine after 48 weeks. In the trial, the safety profile of oral calcitonin did not substantially differ from nasal calcitonin or placebo. The trial results were published in the Journal of Bone and Mineral Research.4

Tarsa is preparing to file an NDA in 2014 for the use of its oral calcitonin in the treatment of postmenopausal osteoporosis.

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.