Aspartame was upheld as a safe general artificial sweetener after the FDA reviewed an Italian study by the European Ramazzini Foundation (ERF), located in Bologna, Italy. The FDA concluded from the data they received from the ERF that there were uncontrolled variables that obscured the results so the conclusions of the study were wrong to say aspartame is unsafe. The ERF findings went against the five previously conducted negative chronic carcinogenicity studies for aspartame.

    The smallest dose of aspartame given to the rats in the study was 80 ppm (parts per million) in their feed. The researchers calculated 80 ppm to be equivalent to 4 mg/kg in a human. The current acceptable daily intake (ADI) for aspartame is currently 50 mg/kg (milligrams of aspartame per kilograms of body weight) in the USA. The study feed rats in groups of increasing doses of aspartame from 8 weeks until their death. They saw an increase in tumors in rats receiving an equivalent of 20 mg/kg or more of aspartame.

    Erythropoiesis-Stimulating Agents (ESAs) are prescribed to individuals who are anaemic, such as post renal (kidney) transplantation patients and patients on chemotherapies. The FDA has released a strengthened warning about dosing of ESAs. The drugs affected by the safety update are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit).

    The FDA and the manufacturer of these products have agreed on revised product labeling that includes updated warnings, a new boxed warning, and modifications to the dosing instructions. The new boxed warning advises physicians to monitor red blood cell levels (hemoglobin) and to adjust the ESA dose to maintain the lowest hemoglobin level needed to avoid the need for blood transfusions. Physicians and patients should carefully weigh the risks of ESAs against transfusion risks.

    The third oncology program for Sunesis Pharmaceuticals to advance to the clinic, SNS-314 was filed as an Investigational New Drug (IND) with the FDA at the beginning of March.

    SNS-314 inhibits Aurora kinases A, B, and C. Stopping Aurora kinases halts cellular division at the mitotoic phase of the cell cycle. Preclinical studies of SNS-314 in mice tumor models have shown broad anti-tumor activity, and Sunesis plans to initially evaluate SNS-314 as a single agent in patients with advanced solid tumors in phase I clinical trials in the upcoming months. Sunesis also has SNS-595, a cell cycle inhibitor, in clinical phase II trials for lung cancer, ovarian cancer, and leukemiaterm.

    The FDA has approved orphan drug status for Seattle Genetic’s two drugs SGN-33 and SGN-35. Orphan drug status allows Seattle Genetics to obtain marketing exclusivity of the drug upon approval. More importantly, it also allows Seattle Genetics an opportunity to obtain grant funding from the U.S. government to support clinical trials and defray costs. The Orphan Drug Act encourages companies to develop treatment for diseases that affect fewer than 200,000 people a year.

    SGN-33 has shown anti-tumor effects in phase I studies. SGN-33 (lintuzumab) is a humanized monoclonal antibodyterm that targets the CD33 antigen. SGN-33 is expected to enter clinical phase II by the end of 2007 testing mainly older patients with AML and MDS.

Cervical cancer is a form of cancer associated with Human Papilloma Virus (HPV). HPV comprises a diverse group of viruses that have about a 100 members. About 30 of these viruses are sexually transmitted. HPV infections increase the risk of cervical cancer and almost all forms of cervical cancers are coincident with an HPV infection. HPV related cervical cancer is the second leading type of cancer in women right after breast cancer even though its rates have been dropping over the past few decades due to improved early detection by the Pap smear test.