Latest news with #DatarCancerGenetics
Hindustan Times
09-05-2025
- Business
- Hindustan Times
HC seeks Centre's response to firm's plea to allow human trials of cancer vaccine
MUMBAI: The Bombay high court on Wednesday issued a notice to the central drug regulator to respond to a petition filed by a Nashik-based cancer research company seeking permission to conduct phase 1 human trials of its cancer immunotherapy drug, Per-C-Vax. A bench of chief justice Alok Aradhe and justice MS Karnik sought a response from the Central Drugs Standard Control Organisation (CDSCO) after the petitioner, Datar Cancer Genetics Pvt Ltd, claimed that the regulator had arbitrarily rejected its application to conduct phase 1 human trials of its indigenous vaccine to treat solid organ cancers. In its petition, the company said that it had submitted an application to CDSCO to conduct the trials under the New Drugs and Clinical Trials (NDCT) Rules, 2019, on August 2, 2023. The rules mandate CDSCO to respond to the application in 30 days, failing which the plea is deemed to be approved, the petition said. The regulator did not respond to the application within 30 days, it added. Later, CDSCO repeatedly insisted upon pre-clinical animal study data despite Datar Cancer Genetics explaining that, given the nature of its vaccine, this was scientifically impossible, the petition said. On April 22, 2025, the Drugs Controller General of India, Dr Rajeev Singh Raghuvanshi, rejected the application after highlighting deficiencies, the petition said. The company called the rejection 'mala fide' and a 'colourable exercise of power' to defeat the legislative safeguard built into the NDCT Rules to protect the applicants. It also said the rejection was 'a fraud on the statute' and against the larger public good. The company said it has a team of highly qualified individuals comprising seven MDs, 13 PhDs, and 78 scientists with master's degrees in pharmaceutics or biotechnology. It also claimed that it serves patients in multiple countries and regions, such as the US, UK, Europe, Canada and India, and also has a presence in South America and Africa. The company's counsel stated that the vaccine would put India on the world map. 'Ten patients, who are on stage 4 cancer, will be administered this therapeutic help, marking the end of the first trial,' he added. Datar Cancer Genetics urged the high court to declare that its application was deemed approved, considering CDSCO's failure to adhere to the 30-day time frame. It also requested the court to issue directions to the regulator to facilitate all administrative steps that may be required to conduct the clinical trial under the NDCT Rules, 2019. After hearing the plea, the court granted the regulator four weeks to file its reply to the petition and posted the matter for hearing on June 13.
Associated Press
11-02-2025
- Business
- Associated Press
Dr Massimo Cristofanilli, MD Joins Datar Cancer Genetics as Strategic Advisor
NEW YORK and LONDON and MUNICH and NEW DELHI, Feb. 11, 2025 /PRNewswire/ -- Datar Cancer Genetics (DCG), a global leader in non-invasive cancer diagnostics, announces Dr. Massimo Cristofanilli as Strategic Advisor, reinforcing its commitment to advancing early cancer detection and precision treatment. Dr. Cristofanilli, an expert in circulating tumor cells, biomarkers, and molecular profiling, will collaborate with DCG to develop innovative solutions for early and accurate cancer detection and treatment personalization. A Visionary Leader in Cancer Research Dr. Cristofanilli has an esteemed career with over 400 scientific publications on cancer biomarkers, liquid biopsy, and targeted therapies. He is a past President of the International Society of Liquid Biopsy (ISLB). 'It is my pleasure to take up this role,' said Dr. Cristofanilli. 'I look forward to collaborating with the DCG team to drive the development of next-generation cancer diagnostic tests that will form the backbone of transformative technologies to detect and treat cancer.' Enhancing Cancer Diagnostics and Precision Medicine This collaboration will strengthen DCG's leadership in molecular and functional tumor profiling and liquid biopsies, particularly in circulating tumor cells (CTCs). Dr. Cristofanilli will work with DCG's research teams to expand biomarker-driven innovations for challenging cancers. 'Dr. Cristofanilli's expertise is invaluable to DCG's vision of pushing onco-diagnostics forward,' said Dr. Darshana Patil, MD, Senior Director – Global Strategy and Medical Affairs, DCG. 'His leadership will help refine strategies for next-generation, safer, and more reliable technologies,' added Mr. Rajan Datar, Chairman and Managing Director, DCG. About Datar Cancer Genetics Datar Cancer Genetics is a global oncology research company developing non-invasive technologies for improved cancer detection, treatment, and management. The Company's state-of-the-art cancer research centres in the UK, and India are accredited by the relevant certification such as ISO, UKAS, ILAC, CAP and CLIA. The Company serves cancer patients and suspected cases in the UK, European Union, United States, GCC, and India. About Dr. Massimo Cristofanilli Dr. Cristofanilli is a board-certified medical oncologist specializing in molecular diagnostics, liquid biopsy, and drug development, with a focus on metastatic breast cancer. He is Director of Breast Medical Oncology and Scientific Director of the Englander Institute for Precision Medicine at Weill Cornell Medicine. A pioneer in Inflammatory Breast Cancer (IBC), he founded the IBC International Consortium and has co-authored over 400 peer-reviewed publications.
