Immuuntherapie bij lymfklierkanker: BiovaxID(TM), een Vaccinatie - immuuntherapie bij non-Hodgkin geeft goede resultaten uit fase I en II en fase III trials.

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11 januari 2012:
Interessant is aanvullend op onderstaande informatie te vermelden een overzichts artikel van de aanpak met radiotherapie - bestraling in combinatie met vormen van chemo en immuuntherapeutische middelen waaronder ook Zevalin en Bexxar en Yttrium-90: Radioimmunotherapy of Non-Hodgkin’s Lymphoma: From the ‘Magic Bullets’ to ‘Radioactive Magic Bullets’
In het abstract staat dit, maar klikt u op deze link voor het volledige studierapport.

Onderaan staat informatie over immuuntherapie met BiovaxID®. Als u hier klikt kunt u lezen en zien hoe u als patiënt BiovaxID® wellicht kunt verkrijgen:

Source: Radioimmunotherapy (RIT) of lymphoma with Zevalin and Bexxar was approved by FDA in 2002 and 2003, respectively, for the treatment of relapsed or refractory CD20+ follicular B-cell non-Hodgkin´s lymphoma. In 2009, Zevalin was also approved for consolidation therapy in patients with follicular non-Hodgkin’s lymphoma that achieve a partial or complete response to first-line chemotherapy. For follicular lymphoma patients, the overall response and progression-free survival rates have significantly improved since the implementation of RIT. The predominant complication of RIT is hematological toxicity that is usually manageable. There are ongoing trials to further define the expanding role of RIT as first line or concomitant therapy in the treatment of lymphoma as well as for certain antibiotic resistant infections and aggressive malignancies. There is also growing interest in the development of newer protocols for increased and more uniform dose delivery resulting in better outcomes and improved patient survival. This review will primarily focus on the role of RIT in treatment of non-Hodgkin’s lymphoma, which is of established clinical utility and FDA approved. The mechanism of RIT, available radionuclides and pharmacokinetics, therapy administration, clinical utility and toxicities, and future directions would be discussed.

26 mei 2006: Bron: http://www.accentia.net

Met dank aan Maurice die ons hierop attent maakte. We hebben geprobeerd abstracten van studies te vinden maar alle abstracten aangaande deze immuuntherapie zijn in Pubmed vermeld met vermelding "abstract niet beschikbaar". Waarschijnlijk om de presentatie in juni a.s. niet te beïnvloeden. Echter hieronder wat meer informatie over de resultaten tot nu toe met BiovaxID(TM) die o.i. als ze waar zijn echt goede resultaten zijn. Maar neem wel in ogenschouw dat deze informatie gepresenteerd wordt door de producent die er dus alle belang bij heeft om met een goede presentatie te komen. Daarom is het wel jammer dat de echte resultaten uit de eerdere trials niet beschikbaar zijn in een objectieve database. Maar wellicht na 2 juni na de presentatie op ASCO 2006. Hieronder wat informatie in het Engels over deze immuuntherapeutische benadering en de resultaten tot nu toe uit de eerdere trials en waarom ook een fase III studie is goedgekeurd die inmiddels loopt.

Association Between Molecular Remission and Disease-Free Survival in Non-Hodgkins Lymphoma at Over Nine Years Follow-Up To Be Presented
TAMPA, Fla.--(BUSINESS WIRE)--May 24, 2006--

Accentia Biopharmaceuticals majority-owned subsidiary, Biovest International, Inc., to present BiovaxID Phase 2 long-term follow-up data at the annual meeting of American Society of Clinical Oncology

Accentia BioPharmaceuticals, Inc. (NASDAQ: ABPI) and its majority-owned subsidiary, Biovest International, Inc. (OTCBB: BVTI), will present long-term follow-up data from the Company's Phase 2 trial of BiovaxID(TM) at the annual meeting of the American Society of Clinical Oncologists (ASCO). The meeting is the annual educational and scientific event of this professional organization representing physicians who treat cancer patients. This year's meeting will be held June 2 through June 6, 2006, at the Georgia World Congress Center in Atlanta.

Accentia's abstract, entitled "Idiotype Vaccine Therapy of Follicular Lymphoma in First Remission: Association of t(14:18) and Disease Free Survival in a Phase II Cohort," will be presented as part of the Scientific Program in the Lymphoma and Plasma Cell Disorders General Poster Session.

What have the results been with the vaccine?
The first clinical trials were conducted at Stanford in 1988 and involved 41 patients with indolent (slow growing) form of B-cell lymphoma. These patients were given chemotherapy which they had either a complete response (no detectable tumor) or a partial response (reduction in tumor burden of at least 50%). Of the 41 patients, 32 were in remission following their first course of therapy. The remaining 9 patients achieved remission following two or three courses of chemotherapy. The vaccine was given to patients in remission and positive immune response was seen in 20 of the 41 patients given the vaccine. This includes 14 of the 32 patients who were in complete remission following the first course of chemotherapy. The patients were followed and the long term follow up was published in 'Blood' in May 1997. The long term follow-up results showed that the patients who had a positive immune response had a median time to relapse of 7.9 years (time between remission and reappearance of detectable cancer) compared to 1.3 years in those who did not have a positive immune response. In 1997 when the study was published, the median long term survival of all 41 patients was analyzed. The Stanford physician investigators concluded that the long term survival in the vaccination patients was significantly longer than those patients with identical diseases that had not received the vaccination.

The second trial (phase II) was conducted by the National Cancer Institute (NCI) and published in 'Nature Medicine' in October 1999. In this trial, 20 patients were enrolled who had achieved complete remission after chemotherapy (however using a very sensitive DNA-based test, 11 of the 20 considered in complete remission were shown to still have cancer cells in their blood). Of these 20 patients, 95% had significant positive immune response to the vaccine. This included 73% (8 of the 11) who had been determined to still have cancer cells in the blood after chemotherapy. At the end of the study (23 to 53 months), 90% of patients remained in complete remission. Follow up after seven years, median time to relapse had exceeded 7 years in the group who had received the vaccine. BiovaxID(TM), Personalized Anti-Cancer Vaccine from Biovest International, Produces Long Term Clinical Remission and 95 Percent Overall Survival in Patients with Follicular Non-Hodgkin's Lymphoma in Phase 2 Clinical Trial TAMPA, Fla.--(BUSINESS WIRE)--Jan. 10, 2006-- Tumor-Free Survival from Investigational Vaccine Compares Favorably with Published Reports of Chemotherapy Alone, and Regimens That Include Rituxan(R)(1) While There is No Consensus as to What Constitutes a "Cure" of Non-Hodgkin's Lymphoma, Phase 2 Results Are Encouraging Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI), and its subsidiary, Biovest International, Inc. (OTCBB:BVTI), jointly reported long-term follow-up data from its Phase 2 clinical trial of BiovaxID(TM), a personalized vaccine for follicular lymphoma, during a poster session at the 47th Annual Meeting of the American Society of Hematology in Atlanta, December 11, 2005 . (Abstract #2441) In this single-arm, Phase 2 study, patients with follicular B-cell Non-Hodgkin's Lymphoma (NHL) in continuous first clinical remission six months following PACE chemotherapy were treated with a series of subcutaneous vaccinations of BiovaxID. BiovaxID is comprised of tumor-derived Id protein (tumor antigen) conjugated to KLH as a carrier protein administered with GM-CSF (granulocyte macrophage colony stimulating factor). With a median follow-up of 9.2 years, 45 percent of patients remained in continuous first clinical remission at their most recent follow-up (either in 2004-2005), and the overall survival rate was 95 percent. Furthermore, median disease free survival for the patient cohort was 96.5 months (8.0 years). Based on historical data these results suggest a clinically significant advance over current expectations of disease progression. "The results of this Phase 2 study compare very favorably with chemotherapy alone and with CHOP-R where the median disease-free-survival is 2.2 years and 6.9 years respectively. The ongoing Phase 3 trial of BiovaxID vs. non-specific immune stimulation should help to clarify the role of vaccine therapy in patients with follicular lymphoma," said Barry Gause, M.D., co-investigator for the clinical trial at the National Cancer Institute (NCI). "We are encouraged by these long term follow-up data from our Phase 2 study," said Angelos Stergiou, M.D., Director of Product Development, Accentia Biopharmaceuticals. "These results underscore the potential of BiovaxID(TM) as a promising personalized therapeutic vaccine for follicular lymphoma. Patients, physicians, and payors are understandably requesting that, at some point in the battle against cancer, expensive cancer therapeutics need to start to provide cures. Because this disease is considered incurable with existing therapies we are particularly pleased with the reported rate of overall survival without tumor recurrence, which is the gold standard for cancer therapeutics." BiovaxID is designed to evoke the power of each patient's immune system, priming it to recognize and eliminate cancerous lymphoma cells, while sparing normal B-cells. BiovaxID uses complete high fidelity copies of each patient's unique tumor antigen produced in a hybridoma cell line exclusively licensed from Stanford University. Other vaccines currently being evaluated for the treatment of follicular lymphoma are made by molecular cloning and splicing, and incorporate only a portion of the patient's tumor antigen. Background on immunotherapeutics for non-Hodgkin's lymphoma Rituxan is a passive immunotherapeutic consisting of a monoclonal antibody administered intravenously. The monoclonal antibody is directed to an antigen (CD20) present on all B-lymphocytes. Accordingly, Rituxan promotes the elimination of cancerous and normal B-lymphocytes bearing this antigen. Rituxan therapy is typically repeated as necessary at intervals in order to control the lymphoma. Annual sales for Rituxan are about $1.5B. BiovaxID is an active immunotherapeutic which stimulates the production of anti-tumor antibodies and induces a cell-mediated immune response to cancerous B-lymphocytes but not to normal B-lymphocytes. As an active immunotherapeutic, BiovaxID may also provide ongoing immunosurveillance for recurrent tumors.

immuuntherapie, vaccin, lymfklierkanker