>>FRAMINGHAM, Mass., Dec. 11 /PRNewswire/ -- Two highly regarded Harvard Medical School oncologists working with Genzyme Molecular Oncology (Nasdaq: GZMO - news) presented preliminary data this week showing both clinical and immunologic responses from melanoma and breast cancer vaccine trials. The findings were presented at the annual American Society of Hematology conference taking place in Orlando.
Frank G. Haluska, M.D., Ph.D., of the Massachusetts General Hospital and Dana-Farber Partners Cancer Care, is the lead investigator of a phase 1-2 ex vivo antigen specific melanoma vaccine trial, which is the first one of its kind to use two melanoma antigens in a single vaccine. The approach uses a common viral vector to target dendritic cells, known as powerful immune stimulators, with the two antigens. The trial is fully enrolled and has twenty stage 3 and 4 melanoma patients with advanced disease currently being evaluated.
Dr. Haluska's preliminary findings show that this antigen specific approach was well tolerated by the twenty patients and demonstrated immunologic or clinical responses among fourteen of them. Five patients showed clinical evidence of an immune system response to the vaccine including three who experienced vitiligo -- the loss of skin color in some parts of the body -- and two who had asymptomatic changes in the retinas. (The melanoma vaccine is directed against antigens that are also expressed in the skin and eyes.) Ten patients showed evidence of a specific immune response following vaccination that had not occurred earlier. Additionally, eight patients exhibited reactions at the sites of vaccination, further suggesting immunologic activity.
Further findings show that two patients had a measurable clinical response -- one complete response and one partial response -- and a third patient demonstrated stable disease. Two of the three showed evidence of reaction at the sites of vaccination. The patient with a complete response showed immunologic response to the vaccine that had not occurred beforehand. The patient with stable disease had both clinical immunologic response and evidence of a specific immune response to the vaccine that had not occurred earlier.
Joining Dr. Haluska at the ASH conference, David Avigan, M.D., of Beth Israel Deaconess Medical Center, presented an interim clinical update on results from a tumor specific fusion trial in breast cancer being funded by Genzyme Molecular Oncology. In this study, a patient's dendritic cells are combined with their inactivated tumor cells in a chemical fusion process. The fused cells are then injected back into the patient to stimulate a specific immune response against the patient's cancer. Pioneering pre-clinical work for this cancer vaccine approach was developed at the Dana-Farber Cancer Institute under the direction of Donald Kufe, M.D., who continues to oversee the ongoing scientific and clinical investigations for this program.
Nine patients with late-stage metastatic breast cancer have been treated in the trial. One patient has shown a nearly complete clinical response, as well as an immunologic response to the tumor following vaccination. Two patients have demonstrated stable disease for six months. Lastly, in those patients where immunologic response data is available, a majority has shown a response following treatment.
Genzyme Molecular Oncology is also funding Dr. Avigan's ongoing fusion trials in renal cancer and melanoma. At academic meetings earlier this fall, he reported tumor specific immunologic responses in more than thirty percent of patients in both studies. Four patients showed stable disease from these vaccination approaches.
Collectively, the findings demonstrate that vaccination through dendritic/cancer cell fusions is well tolerated, and associated with anti- tumor activity in some patients with metastatic cancers.
``The fact that these trials have shown evidence of clinical and immunologic response is encouraging and supports our approaches in demonstrating the value of vaccines in treating cancer,'' stated Gail Maderis, president of Genzyme Molecular Oncology. ``It's also an enormous privilege to have three, such highly regarded physicians as Drs. Haluska, Avigan and Kufe working with us to advance the field of immunotherapy and test these novel approaches.''
Dr. Haluska is also working with Genzyme Molecular Oncology on an in vivo antigen specific gene therapy trial for patients with early stage melanoma.
Patient treatment and observation in both the antigen specific and fusion vaccine studies will continue into next year.
Genzyme Molecular Oncology expects to file an Investigational New Drug Application (IND) before the end of the year for two additional cancer vaccine trials in melanoma and in kidney cancer using electrofusion as an alternative process to fuse dendritic and tumor cells. Safety and efficacy data from the electrofusion and chemical fusion trials will allow Genzyme Molecular Oncology to compare each of the processes in multiple cancer indications, and will help guide further clinical development of the fusion vaccines.<<
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Cheers, Tuck |
