Halozyme Therapeutics, Inc. (Nasdaq:HALO) and Roche announced dosing of the first patient in a Phase 3 registration trial using Enhanze™ technology (rHuPH20, recombinant human hyaluronidase) in a subcutaneous formulation with Roche’s anticancer biologic, breast cancer and currently is given intravenously (IV).

This innovative technology is anticipated to allow patients with HER2-positive breast cancer to administer Herceptin themselves with or without the support of a healthcare professional via a simple subcutaneous injection. Infusion-free administration with subcutaneous Herceptin means for example that patients with early breast cancer completing their one year of Herceptin therapy would have greater convenience of being able to receive treatment at their family doctor’s office or at home without having to go to a hospital, a significant and welcome benefit.

“The start of this Phase 3 subcutaneous Herceptin trial is a major achievement for the Halozyme and Roche collaboration, representing the first Roche target to reach a pivotal trial. It reflects years of focus, dedication, and teamwork with the aim of providing an innovative solution for improved patient care,” said Jonathan Lim, M.D., Halozyme’s President and CEO. “I congratulate the alliance on the speed of progress to Phase 3.”

In addition, offering Herceptin treatment outside of the hospital setting could reduce costs and potentially help to maximize the efficient use of hospital resources. Subcutaneous Herceptin would come in a ready-to-use administration device instead of an infusion-bag that needs to be prepared by a pharmacist. Physicians and nurses would conduct fewer infusions at the hospital freeing up infusion chair time for other procedures. Additional information about this Phase 3 subcutaneous Herceptin clinical trial can be found at http://www.clinicaltrials.gov and http://www.roche-trials.com.

Halozyme Roche Collaboration

In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme’s proprietary Enhanze technology to Roche’s biological therapeutic compounds. Under the terms of the agreement, Roche made an initial payment to Halozyme for the application of its recombinant human enzyme, rHuPH20, to three pre-defined biologic targets exclusive to Roche. In December 2008, Roche selected a fourth biologic target followed by selection of a fifth target in June 2009 and has the option to exclusively develop and commercialize rHuPH20 with an additional eight potential targets. Pending the successful achievement of a series of clinical, regulatory, and sales events, Roche will pay Halozyme additional milestones as well as royalties on future product sales. Under the collaboration, Roche has access to Halozyme’s expertise in developing and applying rHuPH20 to Roche biologics directed at multiple targets. Roche obtained a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Roche compounds resulting from the collaboration.

About Breast Cancer

Breast cancer is the most common cancer among women worldwide.i Each year more than one million new cases of breast cancer are diagnosed worldwide, and nearly 400,000 people will die of the disease annually.ii In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumor cells. This is known as ‘HER2 positivity’ and affects approximately 20-25% of women with breast cancer.

References

i World Health Organization
ii Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. 2004

Source
Halozyme Therapeutics, Inc.

View drug information on Herceptin.

Genta Incorporated (OTCBB: GETA) announced top-line results from AGENDA, the Company’s Phase 3 trial of Genasense® (oblimersen sodium) Injection in patients with advanced melanoma. AGENDA is a randomized, double-blind, placebo-controlled trial of dacarbazine administered with or without Genasense® in patients who have not previously received chemotherapy. As defined in a prior randomized trial, AGENDA uses a biomarker to define patients who might maximally benefit from treatment.

AGENDA did not show a statistically significant benefit for its co-primary endpoint of progression-free survival. Secondary endpoints of overall response rate and disease control rate (which includes complete and partial responses, plus stable disease ? 3 months duration) also did not show a statistically significant benefit. According to the prespecified analysis plan, the statistical significance of durable response - a secondary endpoint that measures the proportion of patients who achieved a complete or partial response that lasts ? 6 months - is too early to evaluate. The observed differences in progression-free survival, overall response, disease control and durable response all numerically favored the group that received Genasense®.

Overall survival - the other co-primary endpoint in AGENDA - is too early to evaluate, as prospectively specified. An analysis for futility, which was defined as ? 50% conditional power to observe a statistically significant benefit of Genasense under the prospectively assumed hazard ratio of 0.69, has been conducted for the co-primary endpoint of overall survival. AGENDA has passed this futility analysis. The prospectively specified analyses for both overall survival and durable response will be conducted when the data are mature. The safety profile of Genasense in AGENDA was consistent with prior studies.

Quantitative details of the today’s announced results will be presented at the international conference, “Molecular Targets and Cancer Therapeutics”, that will be held November 15-19, 2009 in Boston, MA. The AGENDA results will be featured in an oral session on Monday November 15, 2009 at 5:00 PM ET. The “Targets Meeting” is jointly sponsored by the American Association for Cancer Research (AACR), the U.S. National Cancer Institute (NCI), and the European Organization for Research and Treatment of Cancer (EORTC)

“At this time, we cannot predict whether more mature data will reveal a benefit in either overall survival or durable response,” said Dr. Raymond P. Warrell., Jr., Genta’s Chief Executive Officer. “However, the immediate failure to confirm a significant improvement in progression-free survival will preclude our submission of a regulatory application this year. Management and the Board are currently assessing the impact of these data on the Company’s strategic direction. The Company plans to provide further updates in the near future.

Genta is very grateful for the tireless dedication of our employees and for the contributions of the many physicians, patients, and families who have worked to advance Genasense for the treatment of melanoma.”

About AGENDA

AGENDA is a Phase 3, randomized, double-blind, placebo-controlled trial of dacarbazine administered with or without Genasense® in patients who have not previously received chemotherapy. AGENDA employs a biomarker to define those patients who derived maximum clinical benefit during the preceding study. These patients are characterized by low-normal levels of LDH (lactate dehydrogenase), a tumor-derived enzyme that is readily detected in blood.

Source
Genta

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) announced that the first patient has been enrolled in the Phase 3 program of VEGF Trap-Eye for the treatment of central retinal vein occlusion (CRVO), a leading cause of blindness in adults. Regeneron received a $20 million milestone payment from Bayer Healthcare that was triggered by the dosing of the first patient in the CRVO program. Regeneron also announced that enrollment in the Phase 2 DA VINCI study of VEGF Trap-Eye in diabetic macular edema (DME) has been completed and data are expected during the first half of 2010.

VEGF Trap-Eye, an investigational drug, is being developed by Regeneron and Bayer HealthCare AG for the potential treatment of eye diseases, including the neovascular form of age-related macular degeneration (wet AMD), DME, and CRVO.

The Phase 3 program in CRVO consists of two multinational, one-year clinical studies. The COPERNICUS (COntrolled Phase 3 Evaluation of Repeated iNtravitreal administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and Safety) study is being led by Regeneron and the GALILEO (General Assessment Limiting InfiLtration of Exudates in central retinal vein Occlusion with VEGF Trap-Eye) study is being led by Bayer HealthCare. Patients in both studies will receive six monthly intravitreal injections of either VEGF Trap-Eye at a dose of 2 milligrams (mg) or sham control injections. The primary endpoint of both studies is improvement in visual acuity versus baseline after six months of treatment. At the end of the initial six months, patients will be dosed on a PRN (as needed) basis for another six months. All patients will be eligible for rescue laser treatment. Results from both CRVO studies are expected in 2011.

In wet AMD, Regeneron and Bayer Healthcare are evaluating VEGF Trap-Eye in two ongoing Phase 3 studies, known as VIEW 1 and VIEW 2 (VEGF Trap: Investigation of Efficacy and Safety in Wet age-related macular degeneration). Enrollment in these trials is expected to be completed by the end of this year, and data are expected in late 2010.

Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States. Bayer HealthCare has exclusive rights to market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye.

About CRVO

Over 100,000 people in the United States are estimated to suffer from CRVO, a disease for which there is no current treatment that can be considered standard of care. CRVO is caused by obstruction of the central retinal vein that leads to a back up of blood and fluid in the retina, resulting in retinal injury and loss of vision. The retina can also become “ischemic” (starved for oxygen), resulting in the growth of new abnormal blood vessels that can cause further vision loss and more serious complications. Release of VEGF contributes to increased vascular permeability in the eye and abnormal new vessel growth. It is believed that anti-VEGF treatment may help decrease vascular permeability and edema and prevent the growth of abnormal new blood vessels in the retina in patients with CRVO.

About DME

Diabetic Retinopathy (DR) can lead to significant vision impairment and is a major complication of diabetes. Diabetic Macular Edema (DME) is a common complication of DR that involves fluid collection in the macula. DME is the most prevalent cause of moderate visual loss in patients with diabetes.

DME is a leading cause of adult blindness in the developed world. Severe visual loss is caused by a combination of fluid build-up around the retina and the unnatural growth of blood vessels in the back of the eye.

About VEGF Trap-Eye

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger formation of new blood vessels (angiogenesis) to support the growth of the body’s tissues and organs. It has also been associated with the abnormal growth and fragility of new blood vessels in the eye and vascular permeability and edema. VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF). Investigational VEGF Trap-Eye is a specific blocker of VEGF-A and PlGF that has been demonstrated in preclinical models to bind these growth factors with greater affinity than their natural receptors.

Source
Regeneron Pharmaceuticals