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PNB Vesper Life Sciences has received approval from the Drugs Control General of India (DCGI) to conduct phase 1/2a clinical trials on two of its six molecules arising from its CCK (cholecystokinin receptor) programme. The DCGI approval was based on IND studies based on the ICH, US FDA, DCGI guidelines on efficacy, toxicity and bioavailability studies that it carried out on the New Chemical Entities (NCEs).
The Kochi-based semi virtual research company developed six NCEs. Two of its six molecules have moved from the preclinical development into human trials. Vesper partnered with reputed universities and CROs globally including University of Tennessee USA, Aston University, UK and Vimta Labs, Recipharm, Reliance Life Sciences for preclinical studies and partnered with Lambda Therapeutic Research for clinical trials.
The six molecules include: PNB-001, a CCK2 antagonist, under development for the inflammatory pain and inflammatory bowel Disease. PNB-028, a CCK 3a receptor antagonist is for colon and pancreatic cancer. PNB-081 completed the discovery stage and entered IND studies for pain in conjunction with opioids and pancreatitis. PNB-291 is in development for lung and brain cancer targeting the CCK3b receptor. PNB-102 is in the discovery stage for gastric and stomach cancer. All these molecules have completed the development studies and received patents from countries including US, EU, Japan and China which ends in 2036.
The company said that PNB 001 and 028 are in the final stages of phase 1/2a following the DCGI clearance. Since these are categorised as breakthrough studies in drug development for unmet disease conditions, the approvals are fast-tracked. If all goes well in the human studies, it will take 24 months for commercialisation. We are working on molecules that have a market potential of over US$ 80 billion. Several India and global pharma majors are keen to partner with us and we are in the process of identifying the best of these, PN Balaram, MD of PNB Vesper Life Sciences told Pharmabiz.
Now PNB 001 and 028 are tested for several indications is published as scientific papers in leading international journals. The data on animal studies show that these molecules manifest bioavailability, efficacy with absolutely no toxicity. This has surprised many of our researchers. Moreover the advantage is that since it targets unmet medical conditions, there is no need for expensive phase III trials. US FDA guidelines indicate that an NCE for unmet medical indications can go through the accelerated approval process. This means that after phase 2b, we are eligible to come under the successful molecule category, he added.
BIRAC sanctioned Rs.3 crore for PNB 001 studies for part of the toxicity and clinical studies. For PNB 028, we are awaiting BIRAC funding. Some of the leading scientists who are at our facility in the UK, where basic research is undertaken are: MJ Tisdale, originator of the Aston’s brain cancer drug temozolomide, which generates in excess of US$ 800 million turnover. Dr Eric Lattman leads research activities and Dr L Standker, scientific director, Pharis Biotec GmbH is known to have commercialised a comprehensive patent portfolio on chemotherapeutic peptide mimetics for anti-virals and anticancer agents, he said.
Currently, Indian pharma landscape depicts reluctance to research primarily because its high risk. We have put in both man and material to achieve success till this phase as global and Indian pharma have evinced considerable research for partnerships said Balaram.
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