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California Warns Consumers Not To Eat Seng Chen PiMei Candy
Dr. Mark Horton, director of the California Department of Public Health (CDPH), warned consumers not to eat SENG Chen PiMei Candy, after tests by CDPH found unacceptable levels of lead. Consumers in possession of the candy should discard it immediately.
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Catholic Hospital System Ends Joint Venture With Mass. Insurer Over Differences On Abortion
Massachusetts-based Catholic hospital system Caritas Christi Health Care on Friday ended its joint venture with the Missouri-based health insurer Centene after Cardinal Sean O"Malley of the Archdiocese of Boston insisted that the relationship linked Catholic hospitals too closely to abortion providers, the AP/San Francisco Chronicle reports (AP/San Francisco Chronicle, 6/27). Under the joint venture, Caritas and Centene created a new company, CeltiCare, which would have insured thousands of low-income Massachusetts residents under Commonwealth Care, the state"s subsidized health care program. Financially troubled Caritas, which was founded by the Archdiocese of Boston, said it will continue to participate as a provider in Commonwealth Care but will no longer be a co-owner of the insurance venture with Centene. Caritas will provide care to patients covered by Centene, as it does for patients covered by other private insurers, but it will not provide any services that violate Catholic teachings, such as abortions or sterilizations. In terminating the joint venture, the archdiocese hopes to appease criticism that Caritas would have profited from abortion and other services provided at non-Catholic medical centers, the Boston Globe reports. According to the archdiocese, O"Malley sought the withdrawal after weeks of consultation with the church-affiliated think tank National Catholic Bioethics Center, in response to harsh criticism from antiabortion-rights groups for not blocking the agreement. The withdrawal is "a vindication of sorts" for O"Malley"s critics, who have argued that it would be wrong for Caritas to enter an agreement with a health insurer that covers abortion care, according to the Globe. Andrea Miller, the executive director of NARAL Pro-Choice Massachusetts, said that Caritas" involvement in the joint venture had raised concern from NARAL because of the Catholic Church"s opposition to abortion rights. She said that although Caritas has withdrawn from the venture, "[t]he question remains: Will the involvement of Caritas Christi health providers negatively affect women"s ability to get timely access to reproductive services, including birth control?" Miller added that NARAL hopes that state regulators "will continue due diligence to ensure that referrals and services are provided in a manner that does not delay access to reproductive health services" (Paulson/Lazar, Boston Globe, 6/27).
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To What Extent Can Environmental Pollutants And Alcohol Affect GI Health?
New research quantifies the precise effects of environmental pollutants and alcohol intake on gastrointestinal (GI) health. Both studies being presented this week during Digestive Disease Week® 2009 (DDW®) offer concrete evidence that the environment and alcohol intake can affect GI health and share important insights into new directions for future research. DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.
Cardiovascular

Bionovo Presents Positive Results From Phase 1B Trial Of Bezielle For Metastatic Breast Cancer

Bionovo, Inc. (Nasdaq: BNVI) announced positive results from the Phase 1B clinical trial of Bezielle (formerly BZL101), their lead drug candidate for advanced breast cancer. In the trial, Bezielle showed an excellent safety and tolerability profile, and also showed promising indications of efficacy in a difficult-to-treat population. The Phase 1B clinical trial was conducted at eight US clinical sites under the directorship of Dr. Charles Shapiro, Professor of Medicine and Director of Breast Oncology at Ohio State University. The primary objective of the study was to identify the maximum tolerated dose of Bezielle and to determine the safety, feasibility and preliminary efficacy of the Company"s novel, oral, anticancer therapy. A total of twenty-seven women with metastatic breast cancer were enrolled to the Phase 1B trial. To date, 48 women with advanced breast cancer have been successfully treated with Bezielle in two early clinical trials. In a previous Phase 1A study, Bezielle demonstrated very limited toxicity with a favorable tolerability profile and encouraging clinical activity among a cohort of patients with metastatic breast cancer who had been heavily pretreated with anticancer therapies. Results from this second Phase 1B study provide further support that Bezielle is safe and well-tolerated, with early signs of clinical efficacy. Safety Analysis In comparison to other oral cytotoxic agents, Bezielle was extremely safe and well tolerated. No drug-related deaths or serious adverse events occurred during the study, and 94% of all drug-related adverse events were classified as grade 1 and 2 side effects per the National Cancer Institute Common Terminology Criteria for Adverse Events. The most common adverse events associated with Bezielle were grade 1 and 2 gastrointestinal side effects, accounting for 56% of all drug-related adverse events. Efficacy Analysis Sixteen of the twenty-seven participants in the Phase 1B clinical trial were evaluable according to the Response Evaluation Criteria in Solid Tumors (RECIST). Of these sixteen evaluable women, five (31%) were stable on Bezielle for greater than 90 days and two (13%) were stable on Bezielle for greater than 180 days. Three patients (19%) on Bezielle had objective tumor regression, as evaluated by an independent radiology review. Four patients discontinued from the study with stable disease, and of these four patients, one patient had objective tumor regression during 449 days of Bezielle treatment and continues to be stable off of study medication for a total of 600 days. A second patient who discontinued Bezielle treatment with stable disease continues to be stable for 832 days and has not started any new anticancer treatment. A third patient who discontinued with stable disease was stable for 591 days before evidence of progression. Further analyses on overall survival and progression-free survival will be performed. Dose Escalation and Compliance Overall compliance with study medication was excellent with 90% of prescribed doses taken. A maximum tolerated dose, as defined in study protocol, was never established despite dose escalation reaching a dose that was four times (40g/day) the previously evaluated Phase 1A dose. "We are eager to advance Bezielle to Phase 2 clinical testing as the drug continues to have an improved safety profile over currently available chemotherapeutic agents, and shows encouraging clinical activity in a cohort of women who have been heavily pretreated for metastatic breast cancer," said Dr. Mary Tagliaferri, President and Chief Medical Officer, Bionovo. "We are encouraged by the results of the Company"s second Phase 1 trial in women with advanced breast cancer," said Isaac Cohen, Chairman and CEO of Bionovo. "Despite improvements in currently available breast cancer therapies, the five-year survival rate of women who develop metastatic disease is still only 27%. Many of these therapies cause women with advanced breast cancer additional discomfort through severe side effects resulting in a poor quality of life at the end of life. There are currently over 160,000 women in the United States living with advanced breast cancer who are eagerly awaiting an oral anticancer drug with minimal side effects that can extend life without profoundly diminishing their quality of life. We are aiming to improve the extract formulation so we can further improve on the gastrointestinal symptoms associated with Bezielle treatment. We believe Bezielle may be an important new anticancer agent because its biological selectivity allows it to kill cancer cells without affecting normal cells. This also leads to a dramatically lower side effect profile." Bezielle Bezielle is an oral drug designed for the treatment of advanced breast cancer with a novel mechanism of action. Bezielle targets diseased cells while leaving normal cells healthy and intact. Normal cells depend primarily on the citric acid cycle (>85%) and very little on glycolysis (85%) for energy production. Bezielle induces greater production of reactive oxygen species in cancer cells. This results in high levels of DNA damage and the hyperactivation of PARP. The resulting depletion of NAD and ATP (PARP substrates), results in the inhibition of glycolysis, energetic collapse, and programmed necrosis. There are currently no effective therapeutic cures for advanced breast cancer and treatment is primarily aimed at palliation of symptoms as well as improving overall survival. Over 192,000 women in the United States are diagnosed with breast cancer each year and breast cancer is the second leading cause of cancer death in women. Although survival after breast cancer treatment is improving, there are still over 40,000 deaths per year due to the disease in the Unites States alone. Bionovo, Inc. Bionovo is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women"s health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical s which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and is traded on the NASDAQ Capital Market under the symbol, "BNVI". Forward Looking Statements This release contains certain forward-looking statements relating to the business of Bionovo, Inc. that can be identified by the use of forward-looking terminology such as "believes," "expects," or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including uncertainties relating to product development, efficacy and safety, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, market acceptance, physician acceptance, third party reimbursement, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission, which are available at http://www.sec.gov. Bionovo, Inc. is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise. Bionovo, Inc


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