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| Baxter and Halozyme Announce Completion of Patient Enrollment in Phase III Pivotal Trial of GAMMAGARD LIQUID(TM) with rHuPH20 Enzyme |
“The achievement of complete Phase III enrollment is an important
milestone of Baxter’s work with Halozyme to offer patients more advanced
treatment options,” said
“I am pleased with the efficiency and dedication Baxter has demonstrated
toward our collaboration and their exemplary ability to manage and carry
out the clinical objectives,” stated
This Phase III clinical trial is a prospective, open-label,
non-controlled design underway in 15 centers in the U.S. and About GAMMAGARD LIQUID GAMMAGARD LIQUID is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Important Safety Information GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction. Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable in at risk patients. GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Some viruses, such as B19V or hepatitis A, are particularly difficult to remove or inactivate. GAMMAGARD LIQUID should only be administered intravenously. Immediate anaphylactic and hypersensitivity reactions are a remote possibility. IGIV products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin causing a positive direct antiglobulin reaction and, rarely, hemolysis. Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced red blood cell sequestration. There have been reports of noncardiogenic pulmonary edema (Transfusion Related Acute Lung Injury [TRALI]) in patients administered IGIV. Thrombotic events have been reported in association with IGIV. The potential risks and benefits of IGIV should be weighed against those of alternative therapies. Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with GAMMAGARD LIQUID treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.
For full prescribing information, please visit: About Baxter
About
Halozyme is a biopharmaceutical company developing and commercializing
products targeting the extracellular matrix for the endocrinology,
oncology, dermatology and drug delivery markets. The company's portfolio
of products and product candidates is based on intellectual property
covering the family of human enzymes known as hyaluronidases and
additional enzymes that target the extracellular matrix. Halozyme’s
Enhanze™ Technology is a novel drug delivery platform
designed to increase the absorption and dispersion of biologics. The
company has key partnerships with Safe Harbor Statement
In addition to historical information, the statements set forth above
include forward-looking statements (including, without
limitation, statements concerning the GAMMAGARD-rHuPH20 clinical
development program) that involve risk and uncertainties that could
cause actual results to differ materially from those in the
forward-looking statements. The forward-looking statements are also
identified through use of the words "believe," "enable," "may," "will,"
"could," "intends," "estimate," "anticipate," "plan," "predict,"
"probable," "potential," "possible," "should," "continue," and other
words of similar meaning. Actual results could differ materially from
the expectations contained in forward-looking statements as a result of
several factors, including regulatory approval requirements and
competitive conditions. These and other factors that may result in
differences are discussed in greater detail in each company's reports on
Forms 10-K, 10-Q, and other filings with the
Source:
Baxter Media Contacts |
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