YONKERS, N.Y., October 3 /CNW/ - A new Phase II open label study at McGill University will explore the effect of an investigational drug on patients with recurrent or advanced cancer. Researchers indicate the treatment may help patients who suffer from severe appetite loss, fatigue and weight loss when undergoing aggressive cancer therapy.
Advanced Viral Research Corp. (OTC Bulletin Board: ADVR), a research based biopharmaceutical company dedicated to anti-cancer drug discovery and development, today announced the enrollment of the first patient into the Phase II clinical trial.
The trial is being conducted at McGill University Health Centre (MUHC) in Montreal, Quebec. Dr. Martin Chasen, a medical oncologist / palliative care physician and Clinical Director of the McGill Cancer Nutrition and Rehabilitation Program at McGill University, is the Principal Investigator.
The Phase II open label study will examine the effect of a 4.0 mL subcutaneous dose of AVR118 on weight, appetite, performance status, and other measures of quality of life in patients with recurrent or advanced malignancies. AVR118 will be administered daily for a trial period of 28 days. Patients who appear to benefit from the trial period dosing will be eligible to continue on AVR118, generating longer term efficacy data.
According to Dr. Chasen, "AVR118 may offer a new treatment paradigm in palliative care. Early identification and treatment of patients will hopefully enable us to reduce the severely debilitating effects of cachexia and chemotherapy."
Enrollment initially will include 14 patients between the ages of 18 and 85 who have recurrent or advanced malignancies and are suffering from symptoms of cachexia, including muscle wasting, severe fatigue and loss of appetite. Pending review of preliminary data, there is a provision to increase enrollment to 30 patients.
"We are excited to have our first patient enrolled at McGill and hope to improve the quality of life for all patients in this trial. Our company remains committed to contributing to cancer symptom control and advancing palliative care research," said Stephen M. Elliston, President and Chief Executive Officer of ADVR.
Advanced Viral Research Corp. is a New York biopharmaceutical company dedicated to improving patients' lives by researching, developing and bringing to market new and effective therapies for the control of symptoms associated with cancer and other serious diseases. Its initial compound AVR118 represents a new class of cytoprotective agent that targets, among other things, cachexia related disorders. Various degenerative conditions associated with body wasting (cachexia) such as cancer, HIV-AIDS and chronic inflammation are potential disease targets for AVR118 therapy. AVR118 has also been shown to have topical wound healing properties in animal models.
Note: This news release contains forward-looking statements that involve risks associated with clinical development, regulatory approvals, including application to the FDA, product commercialization and other risks described from time to time in the SEC reports filed by the Company. AVR118 is not approved by the U.S. Food and Drug Administration or any comparable agencies of any other countries. There is no assurance that the Company will be able to secure the financing necessary to continue and/or complete the clinical trials of AVR118 or satisfy certain other conditions relating to clinical trials including obtaining adequate insurance on terms acceptable to the Company. The Company undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
For further information regarding Advanced Viral Research Corp., please visit the website at http://www.adviral.com.