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

To: tuck who wrote (436)	1/9/2003 10:45:40 AM
From: tuck	Respond to of 438

>>FRAMINGHAM, Mass., Jan. 9 /PRNewswire-FirstCall/ -- Genzyme Molecular Oncology (Nasdaq: GZMO - News) today announced positive findings from the completion of one of its cancer vaccine studies in melanoma. The Phase I/II trial is the first one of its kind to have utilized two melanoma antigens included in adenovirus vectors in a single vaccine. Frank G. Haluska, M.D., Ph.D., of the Massachusetts General Hospital and Dana-Farber Partners Cancer Care, is the lead investigator of this multicenter vaccine study. "The clinical and immunologic response data from this trial are encouraging," stated Dr. Haluska. "With one patient sustaining a complete response for more than a year and a half, and another two patients demonstrating either a partial response or stable disease, this study provides good reason for optimism that this vaccine approach could prove to be effective in treating melanoma." The approach used in this clinical trial involved two common viral vectors modified to express melanoma specific proteins, or antigens. These vectors were introduced to the patient's immune-stimulating dendritic cells ex vivo in a cell processing facility, and then injected back into the patient under the skin in a series of up to six vaccinations. The intent of this strategy is to spark the patient's immune system and direct it to attack cancer cells displaying either of the two melanoma antigens. The trial enrolled patients with locally advanced or metastatic melanoma, the majority of whom had received prior treatments for their disease. Of the twenty-seven patients enrolled in the study, twenty-one were evaluable for response assessment. Clinical Trial Results: The trial results show that during the study period, clinical or immunologic responses were observed in fifteen of the twenty-one (71%) patients treated. Three patients exhibited a clinical response, with one of them sustaining an ongoing pathologic complete response as evidenced by the entire resolution of the melanoma for more than eighteen months following treatment. A second patient demonstrated a partial response to the vaccine. Although this patient developed disease progression in the brain approximately five weeks after the partial response was observed, he remains alive eighteen months following study completion. A third patient demonstrated stable disease of ten months duration. The first two patients exhibiting melanoma regression showed evidence of immune reaction at the sites of vaccination. Further, the patient with the complete response showed an immunologic response to the vaccine that had not occurred before treatment. The two patients demonstrating a partial response and stable disease sustained clinical events consistent with an immunologic response to vaccination, as evidenced by skin depigmentation -- the loss of skin color in some parts of the body -- and asymptomatic retinal changes, respectively. (The melanoma vaccine is directed against proteins that are also present in the skin and retina of the eye). These responses are important because they demonstrate that the vaccine stimulated the patient's immune system in some manner. Overall, of the twenty-one patients vaccinated in the trial, eight showed an immune reaction at the sites of vaccination, five experienced skin depigmentation, and three exhibited asymptomatic changes in their retinas. Additionally, eight of twelve patients assessed (67%) exhibited an immunologic response to the vaccine that had not occurred before treatment. Multiple responses were observed in some patients. The related adverse events were mild or moderate. Those reported in more than ten percent of patients included flu-like and flu-related symptoms, such as fatigue, shaking chills, headache, nausea, vomiting and muscle aches. Asymptomatic retinal changes in the three patients mentioned above were the only treatment-related serious adverse events reported. "The fact that this trial has shown both evidence of clinical and immunologic response is encouraging and further demonstrates the potential value of therapeutic vaccines in treating cancer," stated Gail Maderis, president of Genzyme Molecular Oncology. "We will compare these data with findings from our in vivo, antigen-specific melanoma trial using the same modified viral vectors to determine the best approach to advancing an antigen- specific product toward commercialization." Patient treatment is complete in that in vivo melanoma study and final data is expected in the first half of 2003. Genzyme Molecular Oncology early last month reported data from a patient-specific cell fusion trial in breast cancer. Two additional trials in renal cancer and melanoma using this fusion approach have completed all patient treatment and trial data are expected to be available in this quarter.<< snip Cheers, Tuck