By Kim Coghill

Washington Editor

Hemosol Inc.¿s stock dropped 44.42 percent Tuesday after the Toronto-based company said the FDA has asked for changes in the Phase III trial protocol for Hemolink, a red-blood cell substitute.

The news means it is unlikely that Hemosol will complete the trial in the first quarter of 2002 as originally planned. Some analysts say the FDA¿s request could push back development of Hemolink, a purified, human-derived hemoglobin replacement product, by one year.

Hemosol¿s stock (NASDAQ:HMSL) closed Tuesday at $4.28, down $3.22.

In a conference telephone call Monday, John Kennedy, Hemosol¿s CEO, said the FDA¿s requested changes are related to the dosing schedule of the product and have nothing to do with safety and efficacy.

¿We are obviously disappointed in what was confirmed today,¿ Kennedy said. ¿We very strongly believe in our protocol, we think it is really the best thing to do and we are absolutely committed to pushing this over the goal line. I think it is important to note that we have a great product here and we are more confident than ever in it. Our safety profile is good and we are just going to keep hammering away.¿

Kennedy said he¿s expecting written notification from the FDA shortly and hopes to meet with U.S. officials within the next few weeks. He said he¿s not sure whether another trial will be requested and does not believe the U.S. issues will impact Hemolink¿s approval in Canada, which is expected later this year, or the UK, expected later.

The problem lies in the HLK-304 trial of 900 coronary artery bypass grafting surgery patients who receive four units of blood. The primary endpoint is reduction of donated red blood cells.

Initially, the trial was scheduled to include 700 patients, but Jason Hogan, Hemosol¿s director of investor relations, said the design ended up limiting the number of participants due to its exclusion to platelet inhibitor patients. And in May, Hemosol submitted an amendment to the FDA that included platelet patients and increased enrollment from 700 to 900. Also, Hemosol started another smaller supplemental trial (HLK-212) in which patients would receive eight units of blood.

¿The FDA changed course here,¿ Hogan told BioWorld Today. ¿Originally, they said HLK-304 was approved, but then they brought up additional concerns. Now they say HLK-304 plus [the amendment] is not sufficient for a pivotal trial.¿

When asked in the conference call whether the FDA is going to seek another Phase III trial at the same dose of the HLK-212 supplement, Kennedy said, ¿I certainly hope not.¿

He added, ¿I can¿t be more precise on the clinical development program or what effect this will have on the timeline at this point. Clearly, we are not going to make our target to start the protocol in the next six weeks.¿

The company¿s stock dropped 32 percent to close at $11.56 about a year ago, when preliminary results from a Phase III study failed to show statistical significance. Hogan said that study ended up being successful and was used for the UK and Canada submissions. (See BioWorld Today, June 13, 2000.)