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Biotech / Medical : GZMO -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (435)	12/10/2002 12:05:37 PM
From: tuck	Read Replies (1) \| Respond to of 438

>>FRAMINGHAM, Mass., Dec. 10 /PRNewswire-FirstCall/ -- A team of Harvard Medical School oncologists funded by Genzyme Molecular Oncology (Nasdaq: GZMO - News) presented encouraging data late yesterday afternoon from a Phase I/II breast cancer vaccine clinical trial. The findings from the study were presented at the annual American Society of Hematology conference taking place in Philadelphia. David Avigan, M.D., director of the bone marrow transplant program at the Beth Israel Deaconess Medical Center in Boston, was the lead investigator of the trial and presented the clinical results. "While this is an early-phase study, the data demonstrate that cell fusion vaccination of patients with metastatic breast cancer is associated with the stimulation of immunologic responses," stated Dr. Avigan. "The findings also show clinical activity in a subset of patients, as demonstrated by a very good partial response in one of the patients and stable disease in two others. These results are promising and demonstrate the potential value of using vaccines to treat cancer." The proprietary vaccine used in this clinical trial was produced using a cell fusion technology in which cancer cells surgically removed from the patient are chemically combined with powerful, immune-stimulating (dendritic) cells. These newly formed cancer cell/dendritic cell fusions are then delivered back to the patient in the form of a vaccine through injection under the skin. Pioneering pre-clinical work leading to the development of this cancer vaccine approach was performed at the Dana-Farber Cancer Institute under the direction of Donald Kufe, M.D., who remains involved in the ongoing scientific and clinical investigations of this program. Clinical Trial Results: Ten patients with late-stage, heavily pre-treated metastatic breast cancer were vaccinated in the open-label study. As reported by Dr. Avigan, two patients showed measurable tumor regressions following the vaccine therapy. The first demonstrated a very good partial response to the vaccine through the shrinkage of a large chest wall tumor mass. This patient also showed a significant immune response following vaccination. The second patient showing tumor regression exhibited a decrease in tumor size at some disease locations in the body following vaccination though overall demonstrated stable disease of all reported lesions for up to six months following vaccination. A third patient with metastatic disease confined to the bones and chest wall lining also showed stable disease six months following vaccination. Additionally, a majority of treated patients in the study demonstrated an immunologic response following vaccination, as measured by two different in vitro assays. Dr. Avigan reported that there were no related serious adverse events in this study. Dr. Avigan reported that related adverse events included transient pain at the tumor site after receiving the vaccine, muscle aches and flu-like symptoms, injection site reactions such as muscle twitching, burning and itchiness, fever, fatigue, and skin itchiness. "The fact that patients in this breast cancer trial have shown evidence of immunologic response and clinical activity supports our broad approach in cancer vaccine development," stated Gail Maderis, president of Genzyme Molecular Oncology. "This first study provides proof of principle for the fusion approach to produce cancer vaccines. Research is continuing and we are also now evaluating another variation of this approach to determine the best path forward toward product commercialization." Genzyme Molecular Oncology is also supporting two additional chemical fusion trials, led by Dr. Avigan, in renal cancer and melanoma. Data from these two trials are expected to be available next month.<< snip Cheers, Tuck