JOIN USLab offers hope on fracture healing
Many a doctor’s dream of having an oral medicine for rapid fracture healing may soon become a reality, thanks to a research being carried out in an Indian laboratory that has now tied up with a US-based drug company.
Buoyed by promising laboratory results, a US-based pharmaceutical company, Kemxtree, has signed an agreement with Central Drug Research Laboratory (CDRL) Lucknow for pre-clinical and clinical development of two new molecules identified and characterised by them.
The drug candidates were isolated from the stem-bark of Kashmir Elm, a tree found in the mountains from Afghanistan to Nepal including Kumaon and Garhwal Himalaya of India. The tree grows at elevations of 800 to 3000 mts above mean sea level.
Researchers were attracted to this plant because of its traditional use for fracture healing among residents of Kumaon and Garhwal. Laboratory studies led to identification of two chemical entities known as GTDF and QCG which induces bone formation. Animal trial results were promising.
The two compounds accelerated fracture healing in both healthy and osteoporotic animals when administered daily by oral route for two weeks. The rate of acceleration was about 36 per cent which is considered highly significant.
In the first phase, GTDF/QCG will be developed as an orally active rapid fracture healing agent. “The company plans to file investigational new drug application with the US Food and Drug Administration as well as Drugs Controller General of India in three years,” team leader Naibedya Chattopadhaya from CDRL told Deccan Herald. As there is no oral pharmacological agent for rapid fracture healing at the moment, the discovery of one would help victims recover early. Aside from their bone healing properties, these novel bone rebuilding agents hold promise for use in the treatment of osteoporosis.
It is estimated that there are at least 300 million osteoporotic patients in India alone.Treatment for rebuilding new bone in osteoporotic patients is an unmet medical need at the moment. The only available bone anabolic therapy is a fragment of human parathyroid hormone (PTH), which has several limitations.
Besides prohibitive cost of treatment, PTH therapy has safety concerns as there is a risk of developing bone cancer. Also it is administered daily via injection, making adherence to treatment less favourable. The therapy can be given to a patient for a maximum of two years and only once in their lifetime.