Hemopure

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    Lee Elder posted Fri, 01 Aug 2003 14:41:00 GMT(8/1/2003)

    Post 205 of 290
    Joined 3/10/2001

    Biopure Receives FDA Response to Hemopure(R) Marketing Application

    CAMBRIDGE, Mass., Aug. 1 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq:
    BPUR) announced today that the U.S. Food and Drug Administration (FDA) has
    completed its review of the company's biologic license application (BLA) for
    Hemopure(R) [hemoglobin glutamer - 250 (bovine)] and issued a letter requesting
    additional information. The letter focuses primarily on clarification of clinical and
    preclinical data and includes some comments on labeling. It does not request additional
    clinical trials. Biopure has applied to market Hemopure in the United States for the
    treatment of acutely anemic adult patients undergoing orthopedic surgery and for the
    elimination or reduction of red blood cell transfusions in these patients.

    With 30 days remaining in the original BLA review cycle, the issuance of the letter has
    suspended the FDA review clock until Biopure submits a complete response.

    "We're encouraged that the FDA has finished its review and provided comprehensive
    feedback in advance of the formal action due date. By maintaining thirty days on the
    review clock, the FDA is encouraging us to work with them to complete the approval
    process as quickly as possible," said Biopure President and CEO Thomas A. Moore.
    "We'll work with the Agency to address the remaining questions and will provide our
    answers as expeditiously as possible."

    Anemia is a shortage of RBCs in the body that can create an oxygen deficit and lead to
    cell damage, organ dysfunction or, in severe cases, death. Acute anemia, usually
    caused by blood loss, is the primary indication for a RBC transfusion. In 1999,
    approximately 1.4 million RBC units were transfused in 500,000 high blood loss
    orthopedic surgical procedures.* These statistics are expected to increase as the
    population ages.

    Hemopure is an oxygen therapeutic, or drug, consisting of chemically stabilized bovine
    hemoglobin formulated in a balanced salt solution. This stabilized, acellular hemoglobin
    circulates directly in plasma (the fluid part of blood) when administered intravenously,
    increasing oxygen delivery and diffusion. The product is compatible with all blood types,
    is stable for three years at room temperature (2 degrees to 30 degrees Celsius), and is
    purified through patented and proprietary techniques that are validated to remove
    potential contaminants.

    Biopure Corporation

    Biopure Corporation, headquartered in Cambridge, Mass., is the leading manufacturer
    and marketer of oxygen therapeutics, a new class of drugs that are intravenously
    administered to deliver oxygen to the body's tissues for the treatment of acute surgical
    anemia and other potential medical applications. Hemopure(R) [hemoglobin glutamer -
    200 (bovine)] is approved in South Africa for the treatment of acutely anemic surgical
    patients and for eliminating, delaying or reducing the need for red blood cell
    transfusion in these patients. The company's veterinary product, Oxyglobin(R)
    [hemoglobin glutamer - (200 bovine)], is a similar oxygen therapeutic approved in the
    United States and European Union for the treatment of anemia in dogs.

    Statements in this press release that are not strictly historical may be forward-looking
    statements. There can be no assurance that Biopure Corporation will be able to
    commercially develop its oxygen therapeutic products, that necessary regulatory
    approvals will be obtained, that anticipated milestones will be met in the expected
    timetable, that any clinical trials will be successful, or that any approved product will
    find market acceptance and be sold in the quantities anticipated. Actual results may
    differ from those projected in forward-looking statements due to risks and
    uncertainties that exist in the company's operations and business environment. These
    risks include, without limitation, the company's stage of product development, history
    of operating losses and accumulated deficits, and uncertainties and possible delays
    related to clinical trials, regulatory approvals, possible healthcare reform,
    manufacturing capacity, marketing, market acceptance, competition and the availability
    of sufficient financing to support operations. The company undertakes no obligation to
    release publicly the results of any revisions to these forward-looking statements to
    reflect events or circumstances arising after the date hereof. A full discussion of
    Biopure's operations and financial condition, and specific factors that could cause the
    company's actual performance to differ from current expectations, can be found on the
    company's Web site at www.biopure.com/corporate/legal/home_legal.htm and in the
    company's filings with the U.S. Securities and Exchange Commission, which can be
    accessed in the EDGAR database at the SEC Web site, www.sec.gov, or through the
    Investor section of Biopure's Web site, www.biopure.com.

    * Theta Reports study entitled "Synthetic Blood Products Worldwide" and the National
    Center for Health Statistics' 1999 National Hospital Discharge Survey.

    Contact:
    Douglas Sayles Biopure Corporation
    (617) 234-6826
    PR@biopure.com Lee Stern (investors)
    The Trout Group
    (212) 477-9007 x22
    lstern@troutgroup.com

    SOURCE Biopure Corporation

    M Jourles posted Fri, 01 Aug 2003 14:49:00 GMT(8/1/2003)

    Post 742 of 3028
    Joined 3/26/2000

    I saw this today too. This is great news. Almost there. I wonder if the WTS will ever dedicate a QFR to hemoglobin substitutes?

    M Jourles posted Fri, 01 Aug 2003 14:53:00 GMT(8/1/2003)

    Post 743 of 3028
    Joined 3/26/2000

    Oh, I sent you an IM too Lee.

    minimus posted Fri, 01 Aug 2003 15:18:00 GMT(8/1/2003)

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    Joined 7/3/2002

    Yeah! Jehovah's Witnesses will soon be able to accept cow blood. Moo....

    F Odrade posted Sat, 02 Aug 2003 00:56:00 GMT(8/2/2003)

    Post 53 of 3666
    Joined 7/12/2003

    Suspicious of any new med treatment here, but...

    compatible with all blood types,

    how do they do this? isn't it still transgenic tissue? have they been able to render it inert so as not to trigger rejection/shock/immune issue? If it is inert, will it still carry oxygen?

    purified through patented and proprietary techniques that are validated to remove potential contaminants.

    does this include the prions and protiens implicated in bovine spongiform encephalopathy (mad cow disease) and other pathogens present in cow, undocumented (yet) in humans?

    and finally, in the legal disclaimers:

    Statements in this press release that are not strictly historical may be forward-looking statements. There can be no assurance that Biopure Corporation will be able to commercially develop its oxygen therapeutic products, (...)

    I'm still really skeptical of the treatment efficacy, though the potential is there. How quickly it comes to market is largely a matter of potential profits though. I wonder if there are any uninterested third party write-ups on these trials yet. Interesting subject...

    Odrade

    M Jourles posted Sat, 02 Aug 2003 01:57:00 GMT(8/2/2003)

    Post 744 of 3028
    Joined 3/26/2000

    Odrade,

    how do they do this? isn't it still transgenic tissue? have they been able to render it inert so as not to trigger rejection/shock/immune issue? If it is inert, will it still carry oxygen?

    If my limited medical memory recalls correctly, the "typing" of blood is based on the shell of the actual red blood cell. The hemoglobin carried inside does not have this typing issue. There is something on the shell of the cell which determines if someone is A, B, AB, etc. A little searching on the web would probably give a better detailed description than I could give.

    studying posted Mon, 04 Aug 2003 01:21:00 GMT(8/4/2003)

    Post 8 of 9
    Joined 7/16/2003

    How much stock money have they invested in it? I mean Brooklyn. Is there any way to tell who the investors are?

    M drwtsn32 posted Tue, 05 Aug 2003 00:36:00 GMT(8/5/2003)

    Post 982 of 6460
    Joined 5/4/2003

    Do we know for certain that the WTS will approve Hemopure transfusions?

    F blondie posted Tue, 05 Aug 2003 01:54:00 GMT(8/5/2003)

    Post 4597 of 37613
    Joined 5/28/2001

    According to the WTS, it is a conscience decision whether a JW accepts products made from the four major blood components.

    ***

    w00 6/15 p. 29 Questions From Readers ***

    Today, most transfusions are not of whole blood but of one of its primary components: (1) red cells; (2) white cells; (3) platelets; (4) plasma (serum), the fluid part.

    Jehovah’s Witnesses hold that accepting whole blood or any of those four primary components violates God’s law.

    However, since blood can be processed beyond those primary components, questions arise about fractions derived from the primary blood components. How are such fractions used, and what should a Christian consider when deciding on them?

    Plasma also carries such proteins as albumin, clotting factors, and antibodies to fight diseases.

    Or if someone is exposed to certain diseases, doctors might prescribe injections of gamma globulin, extracted from the blood plasma of people who already had immunity

    Just as blood plasma can be a source of various fractions, the other primary components (red cells, white cells, platelets) can be processed to isolate smaller parts.

    And other medicines are coming along that involve (at least initially) extracts from blood components (HEMOGLOBIN-BASED PRODUCTS SUCH AS HEMOPURE my comments). Such therapies are not transfusions of those primary components; they usually involve parts or fractions thereof. Should Christians accept these fractions in medical treatment? We cannot say. The Bible does not give details, so a Christian must make his own conscientious decision before God.

    The above material shows that Jehovah’s Witnesses refuse transfusions of both whole blood and its primary blood components. The Bible directs Christians to ‘abstain from things sacrificed to idols and from blood and from fornication.’ (Acts 15:29) Beyond that, when it comes to fractions of any of the primary components, each Christian, after careful and prayerful meditation, must conscientiously decide for himself.

    mizpah posted Tue, 05 Aug 2003 02:36:00 GMT(8/5/2003)

    Post 229 of 653
    Joined 6/19/2003

    Why is it I get a vision of a bunch of Talmudic scholars splitting hairs over issues that really are never addressed in Scripture?

    F blondie posted Tue, 05 Aug 2003 02:39:00 GMT(8/5/2003)

    Post 4600 of 37613
    Joined 5/28/2001

    That's what it is, mizpah. Making the word of God invalid (at least their own version of it).

    It ends up with elders telling the sheep that they cannot understand the Bible without their help.

    Blondie

    Update: Article on Hemoglobin-based products and JWs

    http://www.charleston.net/stories/080403/sci_04blood.shtml

    Sometimes the committee informs doctors when a pharmaceutical company is working on a new product -- such as an artificial hemoglobin in the third stage of clinical trials, Edling says.
    In the case of the hemoglobin, it can be made available on a compassionate basis even though it is not yet approved for marketing by the Food and Drug Administration.

    Complete article follows:

    Click here to return to the Post and Courier
    Bloodless surgery option for Jehovah's Witnesses


    BY WEVONNEDA MINIS
    Of The Post and Courier Staff

    There were times when Julius Strong could exert as much energy as any other 50-some-year-old with no problem. But there also were times when Strong became so winded after exerting himself that it frightened him.

    Those were times that sent him to the doctor for a heart checkup.

    The doctor recommended catheterization to determine the extent of Strong's cardiac problems, and the patient agreed.

    Twenty years before that, another doctor told Strong he probably had two bad heart valves. That was during Strong's hospitalization for a brain aneurysm. But Strong had not focused on the issue since.

    He decided that if his valves didn't bother him, he wouldn't bother them.

    Now, however, things were different.

    The doctor who had just performed Strong's catheterization found one bad valve, not two. But he was telling him he needed cardiac surgery to replace the valve very soon. He also was telling him there was room on the next day's surgery schedule.

    Something else was different, too.

    In the two decades since Strong's previous surgery, he had become a Jehovah's Witness and could not have a blood transfusion, a procedure considered normal in the type of surgery he needed. Those who are members of the faith base their belief on Scripture that it is wrong to do so (Leviticus 7:26-27, 17:10-14; Deuteronomy 12:23-25, 15:23; Acts 15:20, 28, 29, 21:25).

    Luckily, Brother John Gaston, his minister, had told him about the bloodless medicine program at Roper Hospital. So Strong already knew he wouldn't have to enter into a stressful discussion with doctors on the issue of refusing to receive blood.

    His decision would be only about the surgery.

    The doctors, he says, explained to him they could take steps to minimize the loss of blood. They explained that Strong's own blood would be collected, cleaned and re-turned to him during surgery, a procedure called cell saver.

    An increasing number of patients are choosing not to accept blood or blood products as part of their medical treatments, says Loretta Humes, coordinator of the bloodless medicine and surgery program at Roper.

    "We started the program in September 1995," says Humes. "The Jehovah's Witnesses (members of the hospital liaison committee) approached Roper Hospital about treating them without using blood transfusions."

    It was just a matter of getting a cooperative doctor to act as director. Dr. Stanley Wilson has been in that role since the program started.

    "Last year, we served about 300 people," Humes says. "That's about average. We get people from Georgia, North Carolina that come to Roper because of the bloodless medicine. The number has increased gradually over the years."

    Since Roper started its program, McLeod Regional Medical Center in Florence and Spartanburg Regional Medical Center also have instituted bloodless medicine programs.

    Procedures done under the program range from same-day outpatient to open-heart surgery, mitral-valve replacement and colon treatments, says Humes, a nurse by training who has been with the program for five years.

    About 25 to 30 of the people who choose to have procedures done under the bloodless medicine program do so for safety reasons," Humes says. "They are concerned about infection issues. They are not really identifying any specific disease, they are just scared."

    Some Roper doctors choose not to perform bloodless medical and surgical procedures, but most will, she says.

    One of the functions of the Jehovah's Witnesses' hospital liaison committee is to help witnesses better explain their need for bloodless procedures to doctors, says Ron Edling, the committee's spokesman. Programs had been established in other parts of the country when the committee decided to ask all of the local hospitals about establishing a program here, Edling says.

    The committee met with Jim Rogers, former president and CEO of Roper Hospital, and the institution embraced the idea.

    The committee's goal in requesting that a bloodless medicine and surgery program be established was to ensure that doctors would not force blood transfusions on Jehovah's Witnesses, Edling says. In turn, the committee would provide doctors with up-to-date information on bloodless medicine and surgery from its church's database at the Watchtower Bible and Tract Society in New York.

    Sometimes the committee informs doctors when a pharmaceutical company is working on a new product -- such as an artificial hemoglobin in the third stage of clinical trials, Edling says.

    In the case of the hemoglobin, it can be made available on a compassionate basis even though it is not yet approved for marketing by the Food and Drug Administration.

    For a Jehovah's Witness who needs major surgery, the need for bloodless medicine is great, Edling says. "We use to have difficulty with doctors not doing certain types of surgery, or doctors getting court orders," Edling says. "One judge thought it was kind of a right-to-die issue. We explained that ... we would not be seeking out the best of medical treatments if we had a death wish."

    Witnesses who have been served by the Roper program are pleased when they realize the caliber of doctors who are willing to accommodate them, Edling says.

    "The doctors who say 'yes' are very good doctors, who are self-confident and have very good skills. Consequently, we do get excellent treatment and very good results.

    "At Roper, there are 120 to 125 doctors who have said they would be willing to treat witnesses without transfusions."

    There is a preference for not giving a patient someone else's blood, says Dr. David Ellison, a hematologist who participates in the bloodless medicine program at Roper. He says it is good general practice to look for ways to reduce the need for transfusion but that the risks of transfusion are very small.

    "The bloodless medicine program is something that really is designed for the Jehovah's Witness community because you do not have the opportunity for transfusion. There are many people who don't want blood, but they won't refuse to take it at the risk of death. They (Jehovah's Witnesses) do die because of that religious preference. We give people who are getting elective surgery by using erythropoietin (trade name Procrit) to boost the starting level of red blood cells. The more you have before surgery starts, the more you can lose before you get down to a level where you need a transfusion."

    The goal is: "Make more blood, lose less blood and save what you can," Ellison says.

    OPTIONS

    Some techniques used by doctors to eliminate or reduce the need for blood transfusions include:

    ARGON BEAM COAGULATOR: Clots blood during surgery to minimize blood loss.

    CELL SAVER: A device that recycles a patient's own blood that is lost during surgery, collects it, cleans it and returns it to the patient.

    ELECTRO CAUTERY: Uses heat to stop vessels from bleeding.

    ERYTHROPOIETIN: A drug that stimulates the patient's bone marrow to make more red blood cells before surgery.

    HARMONIC SCALPEL: A scalpel that employs vibration and friction to cut and cause blood clotting at virtually the same time.

    HYPERBARIC CHAMBER: Distributes high concentrations of oxygen into blood prior to surgery so that patients better withstand surgical procedures.

    VOLUME EXPANDERS AND HEMODILUTION: Enhances the circulation of a patient's own blood through intravenous fluids.

    Source: New Jersey Institute for the Advancement of Bloodless Medicine & Surgery

    Click here to return to story:
    http://www.charleston.net/stories/080403/sci_04blood.shtml

    F blondie posted Tue, 05 Aug 2003 11:26:00 GMT(8/5/2003)

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    bttt

    gcc2k posted Tue, 05 Aug 2003 21:27:00 GMT(8/5/2003)

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    Joined 3/21/2003

    Thanks for the bump Blondie. Other than the document at dirtclod, I have not seen any official word from Brooklyn that this product is allowed (same for Polyheme). If anyone has additional information, please share.

    M Jourles posted Tue, 05 Aug 2003 21:49:00 GMT(8/5/2003)

    Post 767 of 3028
    Joined 3/26/2000

    These are the only other news articles that I have ever seen on the hemoglobin substitutes:

    http://www.sbsun.com/Stories/0,1413,208~12588~1230815,00.html -- L.C. Cotton of the HIS is quoted as saying:

    "When blood is fractionated beyond those primary components and other blood derivatives, we feel that it is an individual decision,” he said. "If an individual's conscience will allow him to accept the product, then that would be up to that individual. That is between himself and his God."

    The "product" mentioned above is referring to Polyheme.

    In this article - http://classic.sacbee.com/news/news/old/local08_20000924.html - Gregory Brown of the HLC is quoted as saying about Hemopure:

    "Medicine has found ways of breaking down the components into many tiny pieces," he said. "We are saying, that becomes a matter of conscience because the Bible doesn't really address that."

    These two articles and the one Blondie posted are the best examples that we in JWland have on hemoglobin. The WTS still has yet to reply to my letter to them and this is one of the topics that I address in my letter, hemoglobin use.

    M Jourles posted Tue, 05 Aug 2003 21:51:00 GMT(8/5/2003)

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    gcc2k is referring to this page -- http://www.dirtclod.com/blood.html where it says that Hemoglobin-based blood substitutes are considered a "Personal Decision."

    gcc2k posted Tue, 05 Aug 2003 22:22:00 GMT(8/5/2003)

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    Joined 3/21/2003
    gcc2k is referring to this page -- http://www.dirtclod.com/blood.html where it says that Hemoglobin-based blood substitutes are considered a "Personal Decision."

    Correct, thanks for the link. Can you explain the origin and/or authoring of this document? Is it an official HLC document, identified with a special WT code like NB-411 or something like that? I've seen the media reports, but because they are from a secular source, many JWs will not accept them as authentic or authoritative.

    ninecharger posted Tue, 05 Aug 2003 22:57:00 GMT(8/5/2003)

    Post 111 of 145
    Joined 6/24/2003

    Ain't Jesus right??

    YOU MAKE THE WORD OF GOD INVALID BY YOUR TRADITIONS.

    Recently a Witless buddy of mine said "WE don't say you can't take blood -it is your conscience." - Yeah..... you decide what to do but if it isn't what WE say, you'll get shot through the effing brain.

    Those dust farting reptiles in NY should just die - ASAP

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