Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

CuraGen velafermin

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Second Phase II study of the oral mucositis (OM) prevention treatment velafermin for patients receiving high-dose chemotherapy prior to an autologous bone marrow transplant for hematologic cancer will begin in the second quarter despite the failure of an initial Phase II study to achieve its primary endpoint - a dose dependent trend in the reduction of severe OM, CuraGen says. The initial trial showed that the lowest dose of the novel fibroblast growth factor evaluated (0.03 mg/kg) produced a significant reduction in the incidence and duration of severe WHO Grade 3 or 4 OM versus placebo. "Despite the lower than expected incidence of OM in the placebo group, and its impact on the statistical assumptions that went into this trial, we achieved our goal of identifying an active single dose of velafermin that we now hope to confirm in a second, well-controlled Phase II study," stated Exec-VP R&D Timothy Shannon. Plans for the new study follow analysis of results first reported in December (1Pharmaceutical Approvals Monthly January 2006, In Brief)...

You may also be interested in...



Coronavirus Update: US Public Confidence In COVID-19 Vaccines Declines

Confidence in the vaccine has slipped in the US, regardless of political affiliation.

Janssen’s Amivantamab Combo Shows Promise In First-Line NSCLC

Janssen presents highly encouraging interim results at ESMO from the CHRYSALIS study with a combination of amivantamab and lazertinib. Based on the data, the global Phase III MARIPOSA study, which will assess the combo versus blockbuster Tagrisso, will begin next month including in South Korea, home to lazertinib's originator. 

China Detains Legend Biotech CEO, Exposes Genetic Material Minefield

Frank Zhang, co-founder and chair of the Hong Kong-listed Chinese biotech Genscript, parent of Nasdaq-listed cell therapy star, Legend Biotech, has been detained by Chinese authorities, along with four employees.

Topics

UsernamePublicRestriction

Register

LL111109

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel