Australian biopharmaceutical group Vaccinoma's melanoma vaccine has moved a step closer to Phase III clinical trials with the US Food and Drug Administration confirming an end-of-Phase II meeting to discuss the company's proposed Phase III study protocol and the current Good Manufacturing Practice production of the vaccine.
With over 600 patients treated with the vaccine to date, Vaccinoma says it has already established that Polynoma-1 is safe and appears effective in extending the life of sufferers of melanoma.
The firm will now test the drug in an adaptive Phase III clinical trial in 650 patients who have advanced melanoma to ensure its effectiveness in slowing down the spread of the disease to other parts of the body. The vaccine works by stimulating a patient's immune response against cancer.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze