Per-C-Vax / Datar Cancer Genetics - LARVOL DELTA

Bombay HC Notice to CDSCO on Denial of Phase I Trial for Indigenous Cancer Drug (Medical Dialogues) - "The Bombay High Court has issued a notice to the Central Drugs Standard Control Organisation (CDSCO) and the Union government following a petition by Nashik-based Datar Cancer Genetics. The company challenges the CDSCO's rejection of its application to conduct Phase I human trials for its indigenous cancer immunotherapy drug, Per-C-Vax, intended for patients recently diagnosed with solid organ cancers....Datar Cancer Genetics contends that the CDSCO's insistence on pre-clinical animal testing data is scientifically unfeasible for Per-C-Vax, which is developed from patient-derived tumor cells or cell lines. The company argues that traditional animal models are inappropriate for evaluating such therapies. Senior counsel Rafiq Dada, representing Datar, informed the court that the vaccine would initially be administered to critical patients during the trial phase."

Corporate lawsuit • Solid Tumor

Bombay High Court seeks Centre’s response to plea to allow human trials for Indian cancer vaccine (Bar & Bench) - "The Bombay High Court on Wednesday issued notice to India’s drug regulator in a plea filed by a cancer research company seeking permission to begin Phase I human trials of its indigenous cancer immunotherapy drug Per-C-Vax, for patients recently diagnosed with solid organ cancers....The company has challenged the Central Drugs Standard Control Organisation (CDSCO) order dated April 22 rejecting its trial application...It has asked the Court to set aside the April 22 order and direct the CDSCO to permit the trial."

New P1 trial • Solid Tumor