Gensia Halts Protara Trial On Panel Advice

21 August 1994

Gensia Pharmaceuticals has reported that an outside panel monitoring a Phase III trial of its protara heart drug in the prevention of complications in cardiac surgery has advised the company to halt the trial as its analysis has revealed definite evidence as to whether the drug is efficacious or not. A company spokeswoman said that the halting of the trial is not thought to be due to any serious adverse reactions in the patients.

The firm said that it will announce the results some time in October, following a review of the data. There was, however, a great deal of confusion in the market, with the company's shares dropping $3 following the announcement, then recovering most of their lost value to end 5% down at $9.50. More than 2.3 million shares changed hands, 12 times the average daily volume for the stock.

It appears that the company itself does not know what the result will be as the study is not yet unblinded. Prior to the announcement, Gensia had reported that the US Food and Drug Administration had notified it that it required successful results from the ongoing trial prior to any potential approval to market the drug in the USA.

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 account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
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



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight