NovaLead Pharma commences Phase 3 Clinical Trial of Its Novel Topical Drug Galnobax for DFU

NovaLead Pharma has completed Phase 1/2 trial of its novel topical drug galnobax for Diabetic Foot Ulcers DFU with encouraging results and negligible safety concerns, informed Supreet Deshpande, CEO, NovaLead Pharma.

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

A Phase 3 trial for this drug is also being conducted at various cities across India like Delhi, Chennai, Pune, Bengaluru, Hyderabad, Nagpur and Chandigarh, and the total recruitment would be about 350 patients. Development of galnobax and the clinical trials is also supported by Department of Biotechnology (DBT) under Biotechnology Industry Partnership Programme (BIPP).

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 enrollment in the trial.

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

In Delhi, the participating institute for the trial is Maharaj Agrasen Hospital under leadership and guidance of Dr Deepak Khandelwal.

In Pune, the participating institutes for the trial are Deenanath Mangeshkar Hospital and Chellaram Diabetes Hospital under leadership and guidance of Dr Manisha Deshmukh and Dr A G Unnikrishnan, respectively.

In Chennai, the participating institutes for the 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 institute for the trial is Crescent Hospital under leadership and guidance of Dr Asif.

In Bengaluru, the participating institutes for the trial are MS Ramaiah Memorial Hospital and Sapthagiri Institute of Medical Science and Research Center under leadership and guidance of Dr Sanjay Desai and Dr C Madhusudan, respectively.