|Hemosol shares close down 65% after trials in key blood product halted
at 17:00 on March 14, 2003, EST.
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|TORONTO (CP) - The blood was drained from Hemosol Inc. shares Friday after the company reported safety problems with its key medical product. |
The stock plunged as much as 75 per cent during the day after Hemosol said it had stopped clinical trials of Hemolink, a blood substitute, because surgery patients could face heart-related complications. The trial suspension, announced late Thursday, is a terrible blow to the Toronto company, analysts said, because it has pinned much of its hopes on the commercial development of Hemolink.
"The future of the company is very much in doubt," said Duncan Stewart, portfolio manager of Tera Capital Corp.
But Hemosol disagreed with that gloomy assessment, calling it "too premature" while medical data are studied.
Hemosol's stock had been halted all day Thursday, pending news. When trading resumed Friday, the stock sank as much as 75 per cent, or $1.54, to an all-time low of 51 cents.
By the bell, it closed at 71 cents, down 65 per cent, or $1.34, on heavy volume of 5.6 million shares - a huge number for the company.
The drop wiped about $62 million off the company's stock market value, which now stands at about $33 million. The stock's 52-week high is $6.35 and its 52-week low was 62 cents.
"The vastly probable outcome of this is that these trials will never restart," Stewart said. "Further, if they don't, they will not get British or Canadian approval - in which case Hemosol essentially has no assets and will run out of cash.
"But one never knows. It's always possible that they may recover from this," he said. But without approval from regulators to sell the Hemolink product commercially, "you're done. And this is really the only product they have."
Hemosol said it halted two trials of Hemolink after the company's safety monitoring board found there was "the potential for an increase in certain cardiac adverse events" - heart problems.
The company didn't elaborate on those side-effects.
" 'Cardiac events' are intolerable," Stewart said, particularly with a product that's meant to be used instead of blood transfusions - a process that carries some risk but has been used with success for decades.
"The standard for safety is so high that this sort of thing is a real problem."
Enrolment in Hemosol's heart-bypass trial in the U.S. was temporarily suspended as the company reviews the data with its safety board and the U.S. Food and Drug Administration. As a precaution, enrolment is also on hold for patients in a new orthopedic surgery trial.
"Until they can conclude that Hemolink is safe . . . they have to suspend the trial," said David Dean, an analyst with Sprott Securities. "If it turns out that at the end of the day the product is not safe, then there is no Hemosol."
But Hemosol disagreed with analysts' opinions about its future, saying it was "too premature" to make that kind of assessment.
"This is obviously not something we had expected would happen," said Jason Hogan, a spokesman for Hemosol.
"It does happen when you're running any clinical study. We have to wait and review the data."
Hogan added: "What was announced (Thursday) does not mean the product does not work. It did not relate to efficacy and it does not mean that the product is not safe. The (safety board) has seen some information and they felt it was necessary to make this recommendation in order to further review that data. And we're going to look at it."
"We feel that Hemolink is still an exceptional product and that its need is still growing within the marketplace."
The safety board is made up of independent medical experts. Hogan noted that the company also has the option of creating an outside independent medical board to examine the data.
Suspension of the trials will also hurt the biotechnology company as it tries to raise more cash this year to fund its development.
"They have around four months to restart the trial or they probably won't have enough money to finish it," Dean said.
The trial suspension is "not going to help" the company raise funds, Hogan noted.
"We don't have an active clinical program on right now and clearly this (safety board) ruling is going to raise concerns with respect to safety," he said. "We need time to assess what exactly this is to be able to have discussions with various parties to determine our course of action."
The company said it will be looking for more cash this year as it ended 2002 with $17.6 million in cash and is burning about $3 million to $3.5 million a month.
The Toronto-based firm reported Thursday a wider loss for the fourth quarter and all of 2002 as it invested in a new plant and pumped money into the Hemolink trials. For the full year, the company posted a loss of $54.8 million, up 42 per cent from the year earlier. GILLIAN LIVINGSTON
|© The Canadian Press, 2002|
Breaking News on HEMOSOL - Stock down 65%!!!
Thank you for bringing this to my attention. There is not a synthetic product out there that begins to have the advantages of a donor blood transfusion in an acute hemorrhage. Some of the artificial oxygen carriers (as they aren't really artificial bloods) had looked fairly promising, but it just shows that many side effects don't come out till the product is used on a wider population range.
Yup, I agree -- only blood is the closest thing to blood.
The thing that angers me most re: the Society's policy on blood as of late is the untimely flip-flop they did in issuing blood card directives which would have at least allowed the patient's OWN BLOOD be stored and used in surgery. At the very least, this would help in elective situations where you would have time to prepare, and since it's one's own blood, other risk factors would be eliminated or reduced...But, the policy barons at the GB did THIS instead! See below from Rado Vluegel's site! The difference, as you will see below, is in that keyword "allogenic"...with much thanks to Lee Elder...
Where is the WTS headed with their blood policy?
By Lee Elder
senior AJWRB member
Recently Jehovah's Witnesses learned that there would be no pocket size advance directives (blood cards) issued this year  and naturally, this has created some speculation as to the reason.
If you are carrying or possess the most recent "released" version of the card which was published in March 1999, you will find it interesting to note that a new version was in fact prepared for this year and published in June 2001. The cards were shipped to some congregations and probably a few were actually distributed to members who were baptized over the summer and fall in congregations that ran out of the older version.
About a month ago, congregations were informed not to distribute these new cards, but rather destroy them. The difference is one line where the older March - 1999 card states "I direct that no blood transfusion [see image 1] (whole blood, red cells, white cells, platelets or blood plasma) be given to me...," the June - 2001 version reads "I direct that no allogeneic blood transfusion [see image 2] (whole blood, red cells, white cells, platelets or blood plasma) be given to me..." So the difference in the cards is the use of the word allogeneic in the June 2001 version.
06/2001 Blood Card (not distributed) -image 2
The word "allogeneic" refers to intraspecies genetic variations. Therefore, an "allogeneic" transfusion is one derived from the blood of a different person. The implication here is clear. The Watchtower Society stood at the threshold of permitting autologous whole blood transfusions and for some reason, presently unknown, suddenly shifted and stepped back.
It seems evident there is a great struggle within the WTS leadership as to how best deal with the WTS disastrous policy on blood. Any who are still convinced that the WTS stands solidly behind this policy and are prepared to die defending the policy (or even worse - permit their children to die) have cause to soberly reflect on their support.
In our view, this may be one of those situations where the governing body voted to permit Jehovah's Witnesses to use their own blood and put the wheels in motion to change the policy - only to have one member of the body change their mind at the last second and call for a re-vote.
We believe that the WTS blood policy will change again and change dramatically from a historical perspective - the question is when. The foundation necessary for the change is in place. Even now Jehovah's Witnesses who write for permission to withdraw and store their blood for the use of WTS approved blood fractions are told they may do so. At present huge quantities of blood are donated by non-JWs, stored and processed to provide all of the blood products permitted by the Watchtower Society.
Soon Jehovah's Witnesses will have access to hemoglobin based blood substitutes like HemoPure and PolyHeme. The WTS will be inundated with tough questions and a whole series of articles will have to follow. This will probably lead to further erosion of the Watchtower's once firm stand:
" Is it wrong to sustain life by infusions of blood or plasma or red cells or the various blood fractions? Yes!.regardless of whether it is whole blood taken from one's own body or that taken from someone else, whether it is administrated as a transfusion or an injection, the divine law applies.Whether whole or fractional, one's own or someone else's, transfused or injected, it is wrong." - The Watchtower 09/15/1961 p. 557-559
To members of the governing body of Jehovah's Witnesses, the collective members of AJWRB ask: "If we are permitted to use all of these blood products, why do we withhold one of the tiniest - platelets - when permitting it would save the lives of so many Jehovah's Witness children and adults who are forced to discontinue their chemotherapy?"
Platelets account for only 0.17% of blood volume. If you look at blood like a dollar bill, platelets would be less than 1/5 of one penny. While a permitted blood product like hemoglobin accounts for nearly 15% of blood volume. There is no justification for Watchtower leaders to maintain a policy that sends all of these people to an early grave. At some point, they must find the courage to right this terrible wrong. When they do, AJWRB will have served its purpose but until then we will continue our mission of educating other Jehovah's Witnesses and the medical community regarding the Watchtower's irrational policy on the use of blood.
Even now work goes ahead on important articles soon to be published in American Medical Journals that will inform physicians about these discrepancies and what they can do to minimize morbidity and mortality within the Jehovah's Witness community.
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