Diabetic foot ulcer (DFU) is a major complication of diabetes where wounds on the foot do not heal and raises risk of amputation in diabetics.
CEO of NovaLead Pharma Pvt. Ltd., Mr. Supreet Deshpande informed that company has completed Phase 1/2 trial of this product for treatment of DFU with encouraging results and negligible safety concerns. Further to that, a Phase 3 trial for this drug is being conducted at various cities across India like Delhi, Chennai, Pune, Bangalore, Hyderabad, Nagpur and Chandigarh; and the total recruitment would be about 350 patients. Development of Galnobax and the clinical trials are also supported by Department of Biotechnology under BIPP program.
The trial details can be accessed at http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=28871 with names of participating hospitals where patients can contact for enrolment in the trial.
Subject to satisfactory completion of Phase 3 trial, Galnobax can be a path breaking treatment for DFU.
In Delhi, the participating Institutes for this phase 3 trial is Maharaj Agrasen Hospital under leadership and guidance of Dr. Deepak Khandelwal
In Pune, the participating institutes for this phase 3 trial are Deenanath Mangeshkar Hospital, Chellaram Diabetes Hospital under leadership and guidance of Dr. Manisha Deshmukh, and Dr. A.G. Unnikrishnan, respectively.
In Chennai, the participating institutes for this phase 3 trial are M.V. Hospital for Diabetes, Madras Diabetes Research Foundation, Sri Ramachandra Medical Center and Apollo Hospital under leadership and guidance of Dr. Vijay Viswanathan, Dr. Muthu Raju, Dr. Sudagar Singh and Dr. Rajesh Kesavan, respectively.
In Nagpur, the participating institutes for this phase 3 trial are Crescent Hospital under leadership and guidance of Dr. Asif.
In Bengaluru, the participating institute for this phase 3 trial is M.S. Ramaiah Memorial Hospital and Sapthagiri Institute of Medical Science and Research Center under leadership and guidance of Dr. Sanjay Desai, Dr. C. Madhusudan respectively.
NovaLead is a drug discovery and development company focused on developing new indications for generic drugs. Enabled by proprietary technology platform, NovaLead's drug repositioning approach is targeted at finding new biological targets for generic drugs, thereby discovering new indication possibilities. Headquartered in Pune – India, NovaLead is funded by top tier venture investors from India and Europe.
The lead candidate in NovaLead's drug pipeline is Galnobax®, which is a topical gel for the treatment of hard to heal Diabetic Foot Ulcer (DFU). The earlier concluded global Phase 1/2 clinical trial has demonstrated that Galnobax® has successfully met both primary and secondary endpoints for safety and efficacy. Given the limitations of existing therapies for DFU, Galnobax® is looked at as a ray of hope by millions of DFU patients worldwide.