DRF 1042 to enter phase 1 trials in August
By Ananth Iyer | 04 Jul 1999
Dr. Reddy''s Laboratories (DRL), the Hyderabad-based pharmaceutical company, is slated to commence clinical trials of its anti-cancer molecule, DRF 1042, within a fortnight of receiving formal approval for these trials from the Indian Council of Medical Research. This approval, according to Dr. A. Venkat, president of Dr. Reddy’s Research Foundation, is expected by 9 August.
DRF 1042, whose therapeutic properties are close to that of the naturally occurring campotothecin (a plant based derivative), is a new chemical molecule discovered at Dr. Reddy''s Research Foundation. Laboratory studies on animals show this anti-cancer compound to be effective in solid cancers such as colon-rectal cancer, breast cancer and cancer of the uterus.
The phase 1 trial for DRF 1042 will be carried out on a sample of 40-50 cancer-affected patients at Mumbai – at the well known Tata Cancer Research Institute – and at Hyderabad simultaneously. Unlike other new drug discoveries, where phase 1 trials involve healthy volunteers, such trials involving anti-cancer compounds are conducted on cancer patients due to cytotoxic effects associated with anti-cancer drugs.
In the current case DRL plans to carry out phase 1 and 2 clinical trials on its own. This is in contrast to the trials of two other discoveries - DRF 2593 (a blood glucose regulating compound) and DRF 2725 (anti cholesterol agent) - where DRL had licensed the development work to a multinational company, In the case of DRF 1042 it may bring in a multinational company only for the phase 3 trials. This, according to Dr. Venkat, would add value to the company''s prospects of getting better royalty.
At the press briefing DRL also formally launched the anti-cancer drug Docetere, an important new class of anti-neoplastic agents with a novel therapeutic action. The company has developed the technology to manufacture the bulk drug docetaxel trihydrate, which is derived from an Indian plant Taxus Baccata.
The drug is available in strengths of 20 mg and 80 mg costing Rs 2,250 and Rs 9,000 respectively and will be marketed by the company''s Critical Care division.
Earlier in the day, Dr K Anji Reddy, chairman of the Dr Reddy''s group, signed a two-year memorandum of understanding with the Cancer Patients Aid Association (CPAA) to donate three per cent of the net realisation value on the domestic sales of Docetere. The payments would be made at quarterly intervals. In turn, Dr Reddy''s would use the CPAA logo and name on the product packs and promotional literature of Docetere.
