Navigation Links
Halozyme Therapeutics Begins Phase 1 Clinical Trial of Bisphosphonate Administered With rHuPH20 Enzyme
Date:12/10/2008

SAN DIEGO, Dec. 10 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology, and drug delivery markets, today announced the commencement of patient dosing for a Phase 1 clinical trial for a bisphosphonate administered with Halozyme's recombinant human hyaluronidase enzyme (rHuPH20) as a subcutaneous (SC) injection. This study will explore the safety, tolerability and pharmacokinetics of SC administration of a bisphosphonate plus rHuPH20. Currently, injectable bisphosphonates must be administered intravenously (IV).

"We are pleased that the first clinical trial is underway for our bisphosphonate program, our third proprietary product development initiative to enter clinical studies," stated Jonathan Lim, M.D., President and CEO of Halozyme Therapeutics. "The bisphosphonate program joins insulin, for diabetes, and Chemophase, for superficial bladder cancer, our other two proprietary programs in clinical development. The goal of Halozyme's bisphosphonate program is to provide an alternative dosage formulation that may offer greater convenience, compliance and tolerability to patients for the treatment of osteoporosis."

This Phase 1 dose ranging clinical trial will assess the safety, tolerability and pharmacokinetics of a bisphosphonate with and without co-administration of rHuPH20 across a range of bisphosphonate concentrations and volumes and various rHuPH20 doses. The study will also compare SC administration of a bisphosphonate plus rHuPH20 to IV bisphosphonate alone.

About Halozyme Therapeutics, Inc.

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. The company's Enhanze Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its key partnerships are with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for up to 13 targets and with Baxter to apply Enhanze Technology to Baxter's biological therapeutic compound, GAMMAGARD LIQUID 10%. In addition, the company has received FDA approval for two products: Cumulase, for use in in-vitro fertilization, and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter International Inc. Halozyme also has a number of different enzymes in its portfolio that target significant areas of unmet medical need. For more information visit www.halozyme.com.

SafeHarbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the potential benefits of administering rHuPH20 with a bisphosphonate) 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 the company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.

    Halozyme Contact                           Media Contacts
    Robert H. Uhl                              Karen Sparks / Joleen Schultz
    Senior Director, Investor Relations        Mentus
    (858) 704-8264                             (858) 455-5500, x275/x215
    ruhl@halozyme.com                          karen@mentus.com
                                               jschultz@mentus.com


'/>"/>
SOURCE Halozyme Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial and Selects Fourth Exclusive Biologic Target
2. Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme in Prostate Cancer Models
3. Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial
4. Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability
5. Halozyme Therapeutics Presents Findings on Combinations of rHuPH20 Enzyme With Bisphosphonates at the American Association for Cancer Research Conference
6. Halozyme Therapeutics Presents Pre-Clinical Studies of Systemic Delivery of Pegylated rHuPH20 Enyzme in Prostate Cancer Models at American Association for Cancer Research Conference
7. Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex
8. Halozyme Therapeutics Completes Enrollment in Chemophase Phase I/IIa Clinical Trial for Superficial Bladder Cancer
9. Orexigen(R) Therapeutics Announces Changes to Its Clinical Programs and Management Team
10. TorreyPines Therapeutics Muscarinic Agonist NGX267 Meets Primary Endpoint in a Phase II Clinical Trial in Patients with Xerostomia
11. Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/14/2017)...  ivWatch LLC, a medical device company focused on ... is pleased to announce it was the Bronze Winner ... and Equipment at the 2017 Medical Design Excellence Awards ... The award was presented by Medical Device and Diagnostics ... New York during MD&M East, ...
(Date:6/12/2017)... , June 12, 2017 Kineta, Inc., a ... announced Kineta Vice President of R&D and Head ... the Pandemic Preparedness for the Northwest and Beyond ... held on June 14, 2017 from 8:30-10:30 AM PDT at ... Dr. Bedard will be joined by ...
(Date:6/9/2017)... and INDIANAPOLIS , June 9, 2017 ... with diabetes. In a further effort to help spread ... by this condition, the International Diabetes Federation (IDF) and ... have come together for the second phase of the ... programme (BRIDGES 2), reaffirming their commitment to helping people ...
Breaking Medicine Technology:
(Date:6/25/2017)... ... 25, 2017 , ... FCPX LUT Vintage Volume 2 for Final Cut Pro ... Vintage Volume 2 contains 60 different color-grade presets, giving editors multiple options for adding ... to single out subjects, plus much more. FCPX LUT Vintage Volume 2 is designed ...
(Date:6/25/2017)... ... ... Republicans in the United States Senate on Thursday released their version of ... differs significantly from the American Health Care Act, which the House passed in May, ... will have to take up the Senate version as-is, if it passes. , The ...
(Date:6/25/2017)... ... June 25, 2017 , ... CareSet Labs released the ... New Orleans. This is a new, greatly improved version of the Doctor Referral teaming ... requests by Fred Trotter and subsequently called the the “Doctor Referral Dataset” as released ...
(Date:6/25/2017)... ... ... June is Men’s Health Month and the focus is on prostate cancer. Second ... U.S. and the third most common cause of cancer related death today; lung cancer remains ... be diagnosed with prostate cancer during his lifetime. Those at highest risk are ...
(Date:6/24/2017)... ... June 24, 2017 , ... The Pennsylvania Athletic Trainers’ Society’s ... and Erie Convention Center on June 8-10. The weekend consisted of many ... award and scholarship presentations, and professional networking. , On Friday June 9th, ...
Breaking Medicine News(10 mins):