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More Women Seek Nonprescription Remedies For Menopause Symptoms
Over-the-counter remedies for menopause symptoms are growing in popularity among some women who fear potential risks from prescription hormone replacement therapy, the New York Times reports. According to the Times, the market for alternative therapies -- such as natural supplements and topical creams -- jumped in 2002 after initial results from the Women"s Health Initiative suggested that HRT could increase risk for heart disease, cancer, stroke and blood clots. Gynecologists estimate that about one-third of menopausal women are treated with conventional prescription hormones, and about one-third are treated with bio-identical hormones -- plant-derived synthetic hormones that mimic the molecular structure of human hormones. The remaining one-third either do not seek therapy for symptoms, are not bothered by symptoms or use over-the-counter therapies. There are more than 500 over-the-counter products available that claim to alleviate menopause symptoms, the Times reports. The treatments include such products as teas, low-dose progesterone creams, black cohosh capsules and phytoestrogens derived from soy and red clover, according to the Times. According to Nutrition Business Journal, the U.S. dietary supplement market associated with menopause increased from $211 million in 1999 to $337 million in 2007.Some studies have raised doubts about the safety and effectiveness of the over-the-counter remedies. Todd Cooperman -- director of consumerLab.com, a private nutrition product-testing lab -- said that his company"s study of more than one dozen products found that five failed to gain the lab"s approval because of problems such as inaccurate labeling or tainted ingredients. The Center for Botanical Dietary Supplements Research this fall is expected to release the results of a study, sponsored by the National Institutes of Health, that aims to determine the efficacy of the ingredients associated with menopause symptom relief. Some studies have questioned the efficacy of progesterone creams, which some experts contend can gather in fat cells and disrupt the production and synthesis of other hormones. Other experts maintain that the products are safe if properly used. Theresa Ramsey, director of the Center for Natural Healing in Arizona, said, "I think over all these products are generally safe, but must be taken in the right circumstances and in conjunction with a mindfully healthy approach to life if they are going to be effective at all" (Sweeney, New York Times, 7/2).

Agendia To Present Multiple Predictive And Prognostic Studies On Breast And Colorectal Cancers At ASCO Annual Meeting
Agendia, a world leader in molecular cancer diagnostics, today announced
News of the day
FDA Approves Multaq To Treat Heart Rhythm Disorder
The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders). The drug is approved to be used in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heart beat.
Oncology

Enrollment In Delcath's Pivotal Phase III Metastatic Melanoma Clinical Trial Achieves Seventy-Five Percent Accrual

Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary percutaneous hepatic perfusion (PHP(TM)) system for the treatment of cancers of the liver, announced today that it has achieved the seventy-five percent enrollment point of its pivotal Phase III clinical trial treating metastatic cutaneous and ocular melanoma to the liver. The participating cancer centers in this trial continue to evaluate and enroll patients and the Company remains on target to complete enrollment this year. Commenting on this important event, Richard L. Taney, President and Chief Executive Officer of Delcath, stated, "Reaching the seventy-five percent enrollment point represents a significant milestone for our Company as we continue to accelerate this trial and accrue the data to support FDA approval of the Delcath PHP System(TM). Our effort to expand the trial to leading cancer centers has produced the accelerated pace that delivers this milestone just months after hitting 50% accrual and we look forward to completing enrollment this year. The clinical data for the first 69 patients will be submitted to the Data Safety Monitoring Board for evaluation once we complete the collection of follow-up data on the recently randomized patients. We look forward to updating our investors at our annual meeting to be held on June 9th." This multi-center clinical study is being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI). Under this CRADA, patients for this study are being treated at the NCI and at top cancer centers throughout the United States. The NCI is serving as coordinating center for the study, which includes the initiation and training of the new clinical trial centers for this important trial. Plans under the CRADA include continuing patient enrollments and completing the clinical testing of PHP as treatment for a number of life threatening liver diseases. The Phase III Study The Phase III study is testing Delcath"s PHP(TM) System for the regional delivery of melphalan to the liver to treat patients with metastatic cutaneous and ocular melanoma who have unresectable tumors in the liver. The Delcath System is designed to deliver significantly higher doses of anti-cancer drugs to a patient"s liver while preventing entry of the drugs to the rest of the patient"s circulation. This isolation limits toxicities that result from systemic chemotherapy treatments. Patients in the Phase III trial initially are randomized into one of two treatment arms, including immediate treatment with melphalan via the Delcath System or treatment with best alternative care. The study is designed to evaluate the duration of tumor response in each of the two study arms. Following guidelines established by U.S. Food and Drug Administration under a Special Protocol Assessment (SPA), when disease progresses in patients enrolled in the best alternative care arm of the trial, they are permitted to "cross over" and receive treatment with the Delcath System. About Delcath Systems, Inc. Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company is testing a proprietary, patented drug delivery system for the treatment of liver cancers. Delcath"s novel drug delivery platform is testing the delivery of ultra-high doses of anti-cancer drugs to the liver while preventing these high doses of drug from entering the patient"s bloodstream. The Company is currently enrolling patients in Phase III and Phase II clinical studies for the treatment of liver cancers using high doses of melphalan. The Company"s intellectual property portfolio consists of twenty-seven patents on a worldwide basis including the U.S., Europe, Asia and Canada. The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to our ability to successfully complete Phase III clinical trials and secure regulatory approval of our current or future drug-delivery system and uncertainties regarding our ability to obtain financial and other res for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made. Delcath Systems, Inc


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