Daratumumab is an investigational human monoclonal antibody that targets CD38 on the surface of multiple myeloma cells and is in clinical development by Janssen using the intravenous route of administration. Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells. Multiple myeloma is the third most common blood cancer in
The Janssen Phase 1b clinical trial will evaluate the safety, pharmacokinetics and antitumor activity of a daratumumab by the subcutaneous route of administration in approximately 128 patients with relapsed or refractory multiple myeloma.
'We believe the transition from an IV to subcutaneous formulation has the potential to provide benefits to patients and health care professionals, including reduced administration time,' said Dr.
Halozyme's ENHANZE technology is based on a proprietary recombinant human enzyme rHuPH20 that targets hyaluronan, a glycosaminoglycan, which is a chain of natural sugars found throughout the body and as a component of the extracellular matrix, to aid in the dispersion and absorption of other injected therapeutic drugs.
Halozyme Collaboration with
In
About ENHANZE™
ENHANZE™ is Halozyme's proprietary drug delivery platform based on the Company's patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections.
About Halozyme
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE, the possible method of action of ENHANZE, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, the number of collaborative targets actually chosen, whether such products are ultimately developed or commercialized, whether milestones triggering milestone payments will be achieved, and statements concerning facilitating more rapid delivery of injectable medications through subcutaneous delivery 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 typically, but not always, 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 unexpected expenditures and costs, unexpected results or delays in development of product candidates and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's Quarterly Report on Form 10-Q filed with the
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