LONDON ¿ SR Pharma plc completed a review of its lead product, SRL172, after it failed in a Phase III trial in lung cancer in April, and concluded that the data support its continued development.
However, the company cannot afford to go it alone and said it is in discussions with potential partners.
The review took in the views of cancer experts, regulatory authorities and potential development partners. Tom Lang, business development manager, told BioWorld International, ¿There is enough supporting data to justify taking it forward. In the world of unlimited resources we would do more cancer studies, but the focus now is on our allergic disorder program. However, we are in discussion with a couple of parties who would be interested in developing the product further [in cancer].¿
SRL172, an immune potentiator, failed to show a statistically significant improvement in survival in the lung cancer trial. But subsequent analysis demonstrated that during the first 16 weeks, when patients were actively receiving anticancer therapy, treatment with SRL172 combined with standard chemotherapy was associated with significantly improved quality of life, relative to treatment with chemotherapy alone.
A 60-patient Phase II trial in renal cancer, which reported in June, did show a significant survival benefit from SRL172 in combination with chemotherapy vs. chemotherapy alone; however, the trial was not prospectively randomized.
SR Pharma, based in London, estimates it would cost #5 million (US$7.3 million) to take SRL172 through Phase III in renal cancer. The company had #9.8 million in June, and has decided to concentrate these resources on the allergy and inflammatory disorders program.
It currently is recruiting for a 120-patient UK Phase II trial of SRP299 for the treatment of moderate asthma, and is planning a Phase II trial of the same compound in atopic dermatitis, following two investigator-led trials, one that was positive and one still in progress.
SRP299 also demonstrated efficacy in a preclinical model of periodontal disease, and SR Pharma now is planning a Phase II trial in this indication, which it expects to start early in 2002.