Hopes are boosted for colorectal cancer patients with the news
that AstraZeneca had moved its immuno-oncology medicine MEDI-4736 into a
mid-stage study in colorectal cancer. The drug, which is designed to help the
immune system fight tumours, will be tested in 48 patients with advanced
disease in the Phase II trial. AstraZeneca is already studying MEDI-4736 in
lung cancer and head and neck cancer.
MEDI-4736 is part of a closely-watched class of drugs known as
anti-PD-L1 therapies, which block a tumour's ability to evade the immune
system's defences. MEDI-4736 is seen as AstraZeneca's most important new drug
hope and it was one of several experimental products flagged by the company in
May in a bid to convince investors the group has a healthy future as an
independent company.
The new open-label Phase II study, which is not yet open
for patient recruitment, is being run by the New York-based Memorial
Sloan-Kettering Cancer Center in collaboration with AstraZeneca.
Well, in Clinical
trials like these, Regulatory submissions are the most decisive milestone for a
client like AstraZeneca in their clinical research. Quality regulatory document
submissions can speed-up the time to market a drug, bring the advantage of new
treatment to patients, and conserve patent life. At Turacoz Healthcare Solutions, Our team of
medical writers have a clear understanding of the global regulatory
requirements/expectations and International Conference on Harmonization (ICH)
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documents for IND and NDA submissions.
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