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(RTTNews) - Early Tuesday, biotechnology company Genentech, Inc. ( | | | ) revealed that an interim analysis of phase III trial showed Avastin in combination with Interferon Therapy improved progression-free survival in patients with previously untreated advanced Renal Cell Carcinoma, a common type of kidney cancer. According to the company, AVOREN, a randomized Phase III clinical study of Avastin (bevacizumab) in combination with interferon alfa-2a therapy in patients with first-line metastatic renal cell carcinoma, or mRCC, met the primary analysis endpoint of significant improvement in progression-free survival, or PFS, compared to interferon alfa-2a therapy alone.

The South San Francisco, California-based company added that the early analysis indicates a trend toward improvement in overall survival in the Avastin plus interferon arm. Avastin is a therapeutic antibody, which is designed to specifically inhibit vascular endothelial growth factor, or VEGF, a protein that plays an important role in tumor angiogenesis and the maintenance of existing tumor vessels. In the treatment, Avastin will interfere with the blood supply to a tumor, which is thought to be critical to a tumor's ability to grow and spread in the body (metastasize).

The randomized, double-blind Phase III trial AVOREN, which is sponsored by Swiss drug maker Roche Holding AG, has 649 patients with first-line mRCC enrolled in the trial. The company noted that patients were randomized to receive either standard therapy of interferon alfa-2a plus placebo or interferon alfa-2a plus Avastin. Avastin was administered every two weeks at a dose of 10 mg/kg.

According to the company, the study was originally designed to measure an improvement in overall survival. However, the primary analysis endpoint was revised, in prior consultation with the FDA, to assess improvement in PFS, defined as the length of time the tumor did not grow or patient death did not occur. Genentech noted that overall survival, time to progression, time to treatment failure, overall response rate and safety profile were the other endpoints of the study.

The study protocol specified an interim overall survival analysis be performed at about 50% of events. The company added that the required events have not yet occurred for a final analysis of overall survival. Genentech now noted that an independent data safety monitoring board, or DSMB, has recommended that patients in the study be made aware of the results and offered treatment with Avastin.

Results from the study would be submitted for presentation at an upcoming medical meeting, the company added. Commenting on the trial results, Hal Barron, Genentech's senior vice president, Development and chief medical officer, said, "We are pleased with the results demonstrating improvement in progression-free survival in this study and plan to discuss the data and the submission of an application for a potential indication in renal cell cancer with the U.S.

Food and Drug Administration. These results reinforce our belief that inhibiting angiogenesis by specifically blocking vascular endothelial growth factor could provide important clinical benefit across a broad range of tumor types." Further, the company noted that the adverse events in AVOREN study were similar to those previously reported for interferon and for Avastin.

The most common adverse events that occurred more often in the Avastin plus interferon arm included bleeding, hypertension and proteinuria. Serious adverse events occurring more often in the Avastin plus interferon arm included fatigue, pneumonia and gastrointestinal perforations. Renal cell carcinoma or RCC is the most common type of kidney cancer, which accounts for nine out of 10 cases, the company said.

As fewer than 10% of late-stage kidney cancer patients will live five years following diagnosis, the company revealed the need for new treatment options. According to the American Cancer Society, there would be 38,890 new cases of kidney cancer and 12,840 kidney cancer deaths in 2006. Further, the company said that another study of interferon plus or minus Avastin in first-line mRCC with a primary endpoint of overall survival is being conducted by the Cancer and Leukemia Group B in the U.

S. Cancer and Leukemia Group is a National Cancer Institute-sponsored clinical research group. The company is yet to report the results of the trial.

In addition, the company noted that it is planning a randomized study of Avastin in combination with another targeted agent in RCC. Genentech pointed out that it is pursuing a broad development program for Avastin that currently includes 130 clinical trials across 25 different types of cancer, based on data showing that VEGF may play a broad role in a range of cancers. Avastin is being evaluated in Phase III clinical trials for its potential use in adjuvant and metastatic colorectal, renal cell, breast, non-small cell lung, prostate and ovarian cancers.

Avastin is also being evaluated in earlier stage trials as a potential therapy in a variety of solid tumor cancers and hematologic malignancies. Earlier on February 26, 2004, Avastin was first approved by FDA as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. Avastin is also indicated in combination with intravenous 5-FU-based chemotherapy for second-line treatment of patients with metastatic carcinoma of the colon or rectum.

Recently, on October 11, 2006, the FDA approved Avastin in combination with carboplatin and paclitaxel for the first- line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer, or NSCLC. So far, the most serious adverse events associated with Avastin in all trials were gastrointestinal perforation, wound healing complications, hemorrhage, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome, or RPLS, neutropenia and infection, nephrotic syndrome and congestive heart failure. According to the company, the most common adverse events in patients receiving Avastin were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis and proteinuria.

Genentech revealed its commitment to establish a broad oncology portfolio of innovative, targeted therapies with the goal of improving patients' lives by changing the way cancer is treated. The company that provides anti-tumor therapeutics in the United States conducts clinical development programs for Rituxan, Herceptin, Avastin and Tarceva. Further, Genentech markets Avastin and Herceptin alone in the United States, while marketing Rituxan with Biogen Idec, Inc.

, and Tarceva with OSI Pharmaceuticals, Inc. DNA closed Monday's regular trading session at $83.32, down $0.

07, on a volume of 2.18 million shares. For the past 52-weeks, shares traded in a wide range of $75.

58-$96.93.

Read more on by www.tradingmarkets.com. All rights reserved.
Keywords: Renal Cell, Phase Iii, Renal Cell Carcinoma, Cell Carcinoma, Leukemia Group, United States
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