BioWorld International Correspondent

Paion AG's Phase III trial of its stroke drug desmoteplase is back on track, following a momentary wobble last week that wiped 34 percent off the company's share price.

The trial's steering committee sought a hold on recruitment into the trial last week, on the recommendation of a data monitoring committee engaged in a third interim safety analysis. The latter body had requested additional data in order to evaluate a potential safety signal. Paion's share price closed at €5.94 (US$7.58) on the Frankfurt Stock Exchange on the news, down €3.07 from its previous close.

A total of 147,528 shares changed hands that day, its greatest volume in its history as a public company, apart from its first week of trading during February 2005.

The evaluation of the additional data was completed early Saturday morning, following which the hold was lifted, and recruitment was allowed to continue.

"For me, the most important thing I would highlight is this committee decided not to make any amendment to the protocol," Christian Orquera, analyst at Berlin-based First Berlin told BioWorld International.

Desmoteplase, a genetically engineered version of a clot-busting protein isolated from the saliva of the vampire bat Desmodus rotundus, is being developed in order to extend the stroke treatment window from three to nine hours. It is being administered via a single bolus injection to qualifying stroke patients.

The primary outcome of the current study, DIAS-2, is clinical improvement at 90 days, assessed under three different scoring systems: the National Institutes of Health Stroke Scale, the Modified Rankin Scale and the Barthel Index.

The data monitoring committee, which comprises three stroke experts and a statistician, originally had been supplied with 30-day data, under the terms of their charter, Paion spokesman Peer Nils Schroeder told BioWorld International. They were then given the full 90-day data for around 130 trial participants who had completed the trial plus whatever data was available on the other 40 subjects who had been recruited at that point.

Symptomatic bleeding is the most common adverse event associated with stroke drugs, but Paion was not supplied with any information about the DMC's concerns, CEO Wolfgang Söhngen told a conference call audience last week. The trial remained blinded throughout the safety assessment. "We have to maintain the statistical integrity of the study in order to use that for any regulatory filing," Schroeder said.

The level of recruitment attained so far suggests that Paion is on track to achieve its recruitment target of 186 by year end, Orquera said. The company, which has partnered desmoteplase in the U.S. with New York-based Forest Laboratories Inc. and in Europe and Asia with Copenhagen, Denmark-based H. Lundbeck A/S, aims to release data from DIAS-2 by mid-2007.

The company's share price recovered most of its losses Monday, when it closed at €8.30. It continued its upward movement Tuesday, closing at €8.60. Orquera has a target price on the stock of €12.20.

"Compared to its peers, it's undervalued," he said.