personalized cancer vaccine targeting B-cell lymphoma is available in Europe as part of a compassionate access program
According to a world-renowned hematologist and a pioneer in lymphoma research, Professor Volker Diehl, M.D., Ph.D., professor of medicine at the University of Cologne: "With the availability of this truly patient-specific vaccine, I believe That hematologists now have a new option for the safe treatment of lymphoma that may improve chemotherapy and existing monoclonal antibody treatments. This treatment is intended to act on the patient's immune system to identify and selectively attack cancer cells, resulting in remissions that may extend longer. To date, follicular lymphoma is a blood cancer that is considered generally incurable and fatal. It is with high hopes and expectations that I welcome a therapeutic approach as personalized and aimed at responding to an urgent need not supported. Professor Dr. Diehl, who founded the German Hodgkin's study group, has been awarded the Bundesverdienstkreuz (Order of Merit of the Federal Republic of Germany) by the German government for what he has accomplished throughout his life in the field of Lymphoma Research.
Biovest and Idis partner to facilitate patient access to this lymphoma vaccine
The results of the phase III study will be presented at the "Best of ASCO" in Paris
Biovest International, Inc. (Free market: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Free market: ABPIQ), announced today that BiovaxID ®, the vaccine developed by Biovest for cancer treatments is available in Europe as part of a compassionate access programme. In accordance with European regulatory protocols, BiovaxID will be distributed by Idis Limited to European health professionals for the treatment of non-Hodgkin's follicular lymphoma and, potentially, for other types of cancers B-cell blood, such as chronic lymphatic leukemia, mantle cell lymphoma and multiple myeloma. Doctors from non-European countries can also contact Idis to learn about the possibility of obtaining BiovaxID, as Idis manages compassionate access programs in more than 100 countries.
According to a world-renowned hematologist and a pioneer in lymphoma research, Professor Volker Diehl, M.D., Ph.D., professor of medicine at the University of Cologne: "With the availability of this truly patient-specific vaccine, I believe That hematologists now have a new option for the safe treatment of lymphoma that may improve chemotherapy and existing monoclonal antibody treatments. This treatment is intended to act on the patient's immune system to identify and selectively attack cancer cells, resulting in remissions that may extend longer. To date, follicular lymphoma is a blood cancer that is considered generally incurable and fatal. It is with high hopes and expectations that I welcome a therapeutic approach as personalized and aimed at responding to an urgent need not supported. Professor Dr. Diehl, who founded the German Hodgkin's study group, has been awarded the Bundesverdienstkreuz (Order of Merit of the Federal Republic of Germany) by the German government for what he has accomplished throughout his life in the field of Lymphoma Research.
The results of the BiovaxID Phase 3 study were recently presented to the plenary session of the American Society of Clinical Oncology (ASCO) Annual meeting. This eight-year, double-blind, controlled, multi-centre, randomized, pivotal clinical trial has shown that BiovaxID significantly prolongs disease-free survival in the treatment of non-Hodgkin's follicular lymphoma. The study found that patients administered BiovaxID had a mean disease-free survival of 44.2 months versus 30.6 months in those with a control vaccine, an increase of 47%. In the study, whose average follow-up is 4.7 years, patients receiving BiovaxID had a risk of recurrence of the 38% lower disease to that of patients receiving the control vaccine. BiovaxID is the first vaccine targeting lymphoma to display such progress in terms of disease-free survival. Moreover, because the vaccine consists of the patient's own cells (autologous), the treatment is safe and well tolerated.
Later in the day, the results of the BiovaxID Phase 3 study will be presented again at the "Best of ASCO" event at the Maison de la Chemistry in Paris, France at 4:00pm local time. The panellists of the presentation on the BiovaxID (presentation 33572) will be Jean-Luc Harousseau, M.D., director of clinical hematology at the Central Hematology Laboratory of Nantes in France and vice-president of the French Society of Hematology as well as Christian Gfsdgs, M.D., Ph.D., Institute of Hematology, Saint-Louis Hospital, Paris, France.
Considering as probable that the administration of booster injections of BiovaxID could greatly improve therapeutic outcomes, Prof. Dr. Diehl added: The recently reported, although impressive, Phase 3 results do No mention of a supplemental diet consisting of periodic injections. Such a supplemental diet may be the key factor likely to continue to stimulate a continuous and persistent immune response, which will improve outcomes and may promote lasting remissions in some patients. Biovest intends to include several booster vaccines for possible maintenance therapies during the delivery of vaccine prescribed in the context of compassionate access programs.
Since BiovaxID is made from tissue extracted by biopsy from the patient's own tumor, the patient who wishes to participate in the compassionate Access program must undergo a biopsy of the lymphoid node before receiving chemotherapy/therapy by Monoclonal antibody. Biopsy-collected cells will undergo a preparation process by biovest, which will retain the vaccine components until the final vaccine is produced by the patient's physician via Idis. In general, the vaccine is administered about 6 months after the end of chemotherapy and consists of five subcutaneous injections of BiovaxID vaccine administered during a 6-month period (months 1, 2, 3, 4 and 6). During each vaccination cycle, patients will also receive, as a maintenance treatment, four daily injections of GM-CSF agent, Immune State stimulator. At the discretion of the doctor, a periodic supplemental vaccination regimen may also be prescribed.
A compassionate Access program (or identified patient) allows physicians to administer research drugs to qualified patients. Under such a programme, medicines may be administered to patients with a serious illness prior to their approval by the European Medicines Agency (EMEA). The term "identified patient" refers to the method of distribution or sale of the product that is delivered to a health care professional for the treatment of an individual patient, assuming that the regulatory protocols of each of the countries are complied with Participants. In Europe, as part of this programme, the drug is most often distributed by the national Health System.
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