TORONTO & WINNIPEG, April 19 /PRNewswire-FirstCall/ - Cangene today reports the beginning of a clinical trial at Weill Medical College of Cornell University in New York City that will test Cangene's WinRho(R) SDF in patients infected with hepatitis C virus (HCV).
Patients infected with HCV currently receive combination treatment with the drugs peginterferon alfa-2 and ribavirin, which can cause severe hematologic effects, including a drop in platelet numbers called thrombocytopenia. Thrombocytopenia leaves the patient's blood unable to clot, possibly causing uncontrolled bleeding that can be fatal. While effective treatments are available for the other blood-related side effects of HCV therapy, thrombocytopenia has remained intractable and often requires abatement of therapy. WinRho(R) SDF is approved in the U.S. for treating a specific type of thrombocytopenia called ITP (immune thrombocytopenic purpura), which arises from an attack on platelets by the immune system and may occur secondary to HIV (human immunodeficiency virus) infection.
This new study will evaluate the safety and efficacy of using WinRho(R) SDF to offset thrombocytopenia in patients with HCV infection who are starting, or already receiving, treatment with peginterferon alfa-2 and ribavirin. Patients with and without HIV co-infection will be eligible for the trial.
"Hepatitis C is a major cause of liver disease. Any interruption in its therapy because of side effects, such as low platelets, substantially decreases the likelihood of cure. This protocol intends to explore whether the treatment of low platelets with WinRho(R) SDF can stabilize the platelet count and thereby permit the treatment of hepatitis C to continue unabated," said Dr. James Bussel, study principal investigator, professor of pediatrics, and director of the Platelet Research and Treatment Program in the Division of Pediatric Hematology-Oncology at Weill Cornell Medical College.
"The success in using WinRho(R) SDF to treat ITP as well as positive results from a recent trial in dengue hemorrhagic fever patients leads us to investigate whether other patient populations could also benefit from treatment. If it is efficacious in this setting, HCV patients may be able to continue with an unattenuated therapeutic regimen," said Dr. John Langstaff, president and CEO of Cangene Corporation.
HCV infection is spread when blood from an infected person enters the body of an uninfected person and may be spread during birth from an infected mother to her baby. Infection becomes chronic in 55-85% of cases and can lead to chronic liver disease. An estimated 2.7 million Americans have chronic HCV infection, although the rate of new infections has declined since blood donor screening virtually eliminated transfusion-related infections.
About WinRho(R) SDF
Sold in more than 40 countries, WinRho(R) SDF is an antibody to a certain type of red blood cell. It is available in freeze-dried and liquid (WinRho(R) SDF Liquid) formulations and is marketed in the U.S. by Baxter Healthcare Corporation. Cangene manufactures the drug in its facility in Winnipeg, Canada.
WinRho(R) SDF (Rho(D) Immune Globulin Intravenous (Human)) is recommended for the treatment of nonsplenectomized, Rho(D)-positive children with chronic or acute ITP, adults with chronic ITP, and children and adults with ITP secondary to HIV infection in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage.
Important Safety Information
In Rho(D)-positive patients with ITP, side effects related to the destruction of Rho(D)-positive red blood cells, most notably decreased hemoglobin, can be expected. However, signs and symptoms consistent with intravascular hemolysis (IVH) have been reported. Physicians should advise patients who are being treated with WinRho(R) SDF to be alert for such signs and symptoms, which include back pain, shaking chills, fever and/or discoloured urine, and occur usually within four hours after administration of the drug. Potentially serious complications of IVH that have been reported include clinically compromising anemia, acute renal insufficiency or disseminated intravascular coagulation (DIC) that have in some cases, been fatal. The extent of risk of IVH and its complications is not known but is reported to be rare, especially for DIC, which is very rare. Physicians are directed to review all prescribing information.
WinRho(R) SDF Liquid contains the sugar, maltose. Maltose in IVIG products has been shown to give falsely high blood glucose levels in certain types of blood glucose testing systems. Due to the potential for falsely elevated glucose readings, only testing systems that are glucose-specific should be used to test or monitor blood glucose levels in patients receiving WinRho(R) SDF Liquid.
Individuals known to have had a severe, potentially life-threatening reaction to human globulin should not receive WinRho(R) SDF or any other immune globulin (Human). Individuals who are deficient in immunoglobulin A (IgA) may have the potential for developing IgA antibodies and have severe, potentially life-threatening allergic reactions.
Products made from human plasma may carry a risk of transmitting infectious agents, including viruses and theoretically the Creutzfeldt-Jakob disease agent.
To treat ITP, WinRho(R) SDF must be administered intravenously. WinRho(R) SDF should not be administered to Rho(D)-negative or splenectomized individuals as its efficacy in these patients has not been demonstrated. General adverse reactions associated with the use of WinRho(R) SDF include body weakness, abdominal or back pain, low blood pressure, paleness, diarrhea, abnormal blood work, joint pain, muscle pain, dizziness, abnormal movement, sleepiness, itchiness, rash, and sweating. In the treatment of ITP, the most common adverse events (No. 2% of infusions) were headache, chills and fever.
About Cangene
Cangene is one of Canada's largest biotechnology companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene carries out research and development in Mississauga, Ontario and Winnipeg. It uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. In addition to its four approved products, Cangene has one additional product that has been submitted for regulatory review and a significant clinical trial program. Cangene is also expanding its contract research and manufacturing business using its drug-manufacturing expertise and the resources of Chesapeake Biological Laboratories, Inc. (a wholly-owned subsidiary). The Company has manufacturing facilities in Winnipeg, Manitoba and Baltimore, Maryland. Cangene's website, www.cangene.com, includes product and investor information, including past news releases. Chesapeake's website is www.cblinc.com.
Forward-looking information
The reader should be aware that Cangene's businesses are subject to risks and uncertainties that cannot be predicted or quantified; consequently, actual results may differ materially from past results and those expressed or implied by any forward-looking statements. Factors that could cause or contribute to such risks or uncertainties include, but are not limited to: the regulatory environment including the difficulty of predicting regulatory outcomes; changes in the value of the Canadian dollar; the Company's reliance on a small number of customers including government organizations; the demand for new products and the impact of competitive products, service and pricing; cost of raw materials, especially the cost and antibody concentration in plasma; fluctuations in operating results; government policies or actions; progress and cost of clinical trials; reliance on key strategic relationships; costs and possible development delays resulting from use of legal, regulatory or legislative strategies by the Company's competitors; uncertainty related to intellectual property protection and potential cost associated with its defence; the Company's exposure to lawsuits and uncertainties related to estimates and judgments used in preparation of financial statements in accordance with GAAP and related standards and other matters beyond control of management. Risks and uncertainties are discussed more extensively in the MD&A section of the Company's most recent annual report and annual information form, which are available on the Company's website or on SEDAR at www.sedar.com. Scientific information that relates to unapproved products or unapproved uses of products is preliminary and investigative. No conclusions can or should be drawn regarding the safety or efficacy of such products. Only regulatory authorities can determine whether to products are safe and effective for the uses being investigated. Healthcare professionals are directed to refer to approved labelling for products and not rely on information discussed in news releases.
The cautionary statements referred to above should be considered in connection with all written or oral statements, especially forward-looking statements, that are made by the Company or by persons acting on its behalf and in conjunction with its periodic filings with the Ontario Securities Commission, including those contained in the Company's news releases and most recently filed annual information form. Forward-looking statements can be identified by the use of words such as "expects", "plans", "will", "believes", "estimates", "intends", "may", "bodes", and other words of similar meaning. Should known or unknown risks or uncertainties materialize, or should management's assumptions prove inaccurate, actual results could vary materially from those anticipated. The Company undertakes no obligation to publicly make or update any forward-looking statements.
Cangene CorporationCONTACT: about Cangene Corporation, please contact Jean Compton, Manager,Investor Relations at (905) 405-2900 or by email at jcompton@cangene.com;To request a free copy of this organization's annual report, please go tohttp://www.newswire.ca and click on Tools for Investors.