NovaLead Pharma topical drug Galnobax for Diabetic Foot Ulcer proceeds for phase 3 trial

"Development of Galnobax and the clinical trials are also supported by Department of Biotechnology under the BIPP program," said Novalead Pharma.

Mumbai: Drug discovery and development company NovaLead Pharma Pvt. Ltd., informed that the company has completed Phase 1/2 trial of its product Galnobax for the treatment of DFU with encouraging results and negligible safety concerns. A Phase 3 trial for the drug is being conducted at various cities across India like Delhi, Chennai, Pune, Bangalore, Hyderabad, Nagpur and Chandigarh. The total recruitment would be about 350 patients.

Development of Galnobax and the clinical trials are also supported by Department of Biotechnology under the BIPP program. Diabetic foot ulcer (DFU) is a major complication of diabetes where wounds on the foot do not heal and raise the risk of amputation in diabetics.

Subject to the satisfactory completion of the Phase 3 trial, Galnobax can be a path-breaking treatment for DFU.

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.

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.

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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 institutions for this phase 3 trial are 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.

Enabled by a 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, the company is funded by top tier venture investors from India and Europe.

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.