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Monotherapy Reveals Biological Activity Without Toxicity in Breast Cancer

May 31, 2008

By FDANEWS.com

Epeius Biotechnologies achieved favorable results in an ongoing Phase I/II study of Rexin-G for metastatic breast cancer unresponsive to conventional chemotherapy.

Interim results of the study of targeted gene delivery in vivo showed that intravenous infusions of Rexin-G demonstrated significant biological activity without toxicity in patients with rapidly progressive, chemo-resistant breast cancer. After the general safety of repeated infusions of the drug was documented, the FDA approved intrapatient dose escalations to gain better tumor control.

The goal of the trial is to confirm the overall safety of Rexin-G and to determine the optimal dosing regimen that would document the significant clinical benefits required to support a Phase II pivotal study, the company said.

New findings in breast cancer research highlighted at major meeting

May 28, 2008

By Vanessa deGier, UCSF

Clinical researchers from the UCSF Helen Diller Family Comprehensive Cancer Center will present new research findings during the 44th American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago May 30-June 3.

Prominent breast cancer researcher Hope Rugo, MD, will present information on early clinical trial findings related to two forms of breast cancer:

Addition of Paclitaxel to Standard Chemotherapy Improves Outcome in Early Breast Cancer

May 28, 2008

By Science Daily

Early breast cancer patients treated with standard chemotherapy followed by paclitaxel had better disease-free survival compared with patients treated with standard therapy alone, according to the final results from a randomized phase III trial.

Paclitaxel and other taxanes are among the most active agents in metastatic breast cancer. Researchers are now testing the drugs in patients with early, non-metastatic breast cancer.

Iressa Shows Promise For Treatment Of Metastatic Breast Cancer When Combined With Hormonal Therapy

May 20, 2008

By Science Daily

Phase II clinical trial led by researchers at The University of Texas M. D. Anderson Cancer Center showed Gefitinib, the once-promising drug formerly approved as a second line treatment for lung cancer, also known as Iressa, enhanced the effectiveness of hormonal therapy for the treatment of specific types of metastatic breast cancer.These findings are surprising and represent the first positive study for Iressa in breast cancer, as well as for the entire class of drugs known as epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors, said Massimo Cristofanilli, M.D., the study’s principal investigator. 

GSK Announces Results of First Phase III Trial Evaluating Tykerb(R) (Lapatinib) Plus Herceptin(R) (Trastuzumab)

May 17, 2008

By PRNews Wire

 Highlights Include:

    — Results demonstrating that TYKERB and trastuzumab together resulted
in a clinically meaningful extension of progression-free survival (PFS)

    — Combining TYKERB and trastuzumab to attack both the inside and
outside of the HER2 receptor may create a more complete HER2 blockade

    — Data demonstrating activity of TYKERB alone despite patients’
previous treatment with multiple lines of trastuzumab and chemotherapy

    LONDON and PHILADELPHIA, May 16 /PRNewswire-USNewswire/ –
GlaxoSmithKline today announced positive data from the first-ever
randomized, multi-center, open label Phase III trial of the combination of
two targeted agents, TYKERB and trastuzumab, in women with HER2-positive
metastatic breast cancer

Blood Test Helps Docs Assess Breast Cancer Treatment

May 17, 2008

By US NEWS

New tool could allow physicians to determine much sooner if therapy is working

A simple blood test to check levels of circulating tumor cells can help doctors more accurately assess how well treatments are working in women with metastatic breast cancer, according to a Georgetown University Medical Center study.

Low Vitamin D May Mean Worse Breast Cancer

May 17, 2008

By Audrey Grayson, ABC NEWS-USA

Vitamin D deficiencies have long been associated with disease, but new research suggests that low levels of vitamin D in women with breast cancer can lead to more aggressive forms of the disease, and even death.Researchers at the University of Toronto studied the correlation between vitamin D levels in the blood, the rate of breast cancer metastases — the incidence of having the cancer spread — and the overall survival rates of 512 women who were diagnosed with breast cancer between 1989 and 1995. The women were followed until 2006.

Researchers found for the first time that women who were vitamin D deficient at the time of their breast cancer diagnosis were 94 percent more likely to have their cancer spread, and 73 percent more likely to die from their cancer, compared with women who were not vitamin D deficient.

Embryonic pathway delivers stem cell traits

May 16, 2008

By Cristin Carr, Whitehead Institute for Biomedical Research

CAMBRIDGE, Mass. – Studies of how cancer cells spread have led to a surprising discovery about the creation of cells with adult stem cell characteristics, offering potentially major implications for regenerative medicine and for cancer treatment.

Some cancer cells acquire the ability to migrate through the body by re-activating biological programs that have lain dormant since the embryo stage, as the lab of Whitehead Member Robert Weinberg has helped to demonstrate in recent years. Now scientists in the Weinberg lab have shown that both normal and cancer cells that are induced to follow one of these pathways may gain properties of adult stem cells, including the ability to self-renew

Request for Pre-IDE Determination Meeting with FDA for AdnaGen’s AdnaTest Breast Cancer Device for Detection of Circulating Brea

May 7, 2008

By Business Wire

SAN ANTONIO – OncoVista Innovative Therapies Inc. (OTC BB: OVIT.OB), a biopharmaceutical company engaged in the development and commercialization of targeted cancer therapies, announced the submission of a request to the U.S. Food and Drug Administration for a pre-IDE determination meeting for its AdnaGen AdnaTest Breast Cancer device for the detection of circulating breast tumor cells. AdnaGen is a subsidiary of OncoVista and focuses on the development of innovative tumor diagnostics by utilizing its proprietary technology for the detection and analysis of rare cells.

OncoVistas Chief Executive Officer, Alexander L. Weis, Ph.D., commented: We are very pleased to have submitted this package to the FDA. The AdnaTest is intended for use as a prognostic test for women with metastatic breast cancer, in whom the presence of circulating tumor cells is associated with decreased progression-free survival and decreased overall survival and as such can be of tremendous benefit in determining those patients who can best benefit from a certain line of chemotherapy treatment