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

PTC Fully Enrolls Duchenne MD Trial; Expects Top-Line Data In Early 2010

This article was originally published in The Pink Sheet Daily

Executive Summary

With FDA approval of the six-minute walk test as primary endpoint, private specialty firm hopes to bring first Duchenne muscular dystrophy drug to market within two years.

You may also be interested in...



A Pair Of GEMS: PTC Unveils Two Platform-Based Deals In One Day

PTC will collaborate with Roche in CNS discovery efforts, while Celgene exercises an option on work done on an oncology target.

A Pair Of GEMS: PTC Unveils Two Platform-Based Deals In One Day

PTC will collaborate with Roche in CNS discovery efforts, while Celgene exercises an option on work done on an oncology target.

R&D, In Brief

Younger recruitment for Diamyd's type 1 diabetes vaccine trial: Diamyd Medical is now recruiting type 1 diabetes patients aged 10 to 20 for the Phase III trial of the Diamyd diabetes vaccine, the firm announced Aug. 27. When Diamyd filed the IND for the trial, the lower age limit was 16 (1Pharmaceutical Approvals Monthly January 2008). FDA lowered the enrollment age in June to 10 years old, and the firm is now increasing its investment in the development program with more clinics and expanded recruitment activities. It will retain 13 of the original clinics and is aiming to add about 30 more. The vaccine, based on autoantigen GAD65, is designed to slow down autoimmune destruction of insulin-producing beta cells. It already has been shown in Phase II to preserve beta cell function for at least 21 months in patients with recent-onset type 1 diabetes. Other ongoing trials are aimed at better understanding natural production of insulin and the immunological mechanism of action of the vaccine, and studying the disease process of developing type 1 diabetes. The firm aims to gain approval for the vaccine in 2012

Related Content

Topics

UsernamePublicRestriction

Register

PS069273

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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