22 mei 2018: lees ook dit artikel: 


7 januari 2018: Bron: J Clin Oncol. 2015 Apr 20; 33(12): 1325–1333.

Als vervolg op onderstaande studies is in 2015 deze studie gepubliceerd: Safety and Survival With GVAX Pancreas Prime and Listeria Monocytogenes–Expressing Mesothelin (CRS-207) Boost Vaccines for Metastatic Pancreatic Cancer

met wel verbeteringen in de overall overleving maar niet echt spectaculair, hoewel een verdubbeling van de overall overleving bij uitgezaaide alvleesklierkanker zeker goed is te noemen.

Response to therapy.

The response to therapy is summarized in Appendix Table A2 (online only). The rate of stable disease was 31% (95% CI, 20 to 44) in arm A and 24% (95% CI, 10 to 44) in arm B (two-sided P = .49). Stabilization or reduction in CA19-9 was seen in 27% of patients (11 of 41) in arm A and 9% of patients (two of 23) in arm B (two-sided P = .08; Fig 4A). The median OS in patients with a stable or better CA19-9 response was 10.3 months (95% CI, 3.2 to not applicable), as compared with 4.0 months (95% CI, 3.4 to 4.9) in patients with CA19-9 progression (HR for death, 0.43; two-sided P = .02; Fig 4B). There was no difference in PFS (data not shown).

Maar zie onderstaande grafieken of lees het volledige studierapport dat gratis is in te zien.

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Heterologous prime/boost of GVAX and Listeria-based vaccines induces robust antigen-specific T-cell immunity and delays tumor growth in experimental mouse pancreatic tumor model. (A) AH1-specific T-cell responses at peak of response in BALB/c mice. On day 0, BALB/c mice (n = 5) were immunized with either 5 × 106 colony-forming units (CFUs) of Lm-AH1 (Lm) intravenously (IV) or 1 × 106 cells of GVAX subcutaneously (SC). On day 14, specific groups were boosted IV with 5 × 106 CFUs of Lm. Seven days after prime and 5 days after boost, spleens from mice were obtained, and interferon gamma (IFN-γ) AH1-specific immune responses were assessed by intracellular cytokine staining. (B) Therapeutic antitumor efficacy of combination of GVAX and Lm in C57BL/6 mice. On day 0, C57BL/6 mice (n = 10) were implanted SC with 1 × 106 Panc02 cells. On day 3, GVAX animals were pretreated with cyclophosphamide 100 mg/kg and PC-61 50 μg. On day 4, mice were vaccinated either SC with 6 × 106 cells of GVAX (3 × 106 irradiated Panc02 cells plus 3 × 106 irradiated B78H1 cells) or IV with 5 × 106 CFUs of Lm-mouse mesothelin (Lm-mMeso). Fourteen days after vaccination, indicated groups were boosted IV with 5 × 106 CFUs of Lm-mMeso. Mice were monitored over time, and tumor growth was measured twice per week. HBSS, Hank's balanced salt solution.

Fig A2.

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Kaplan-Meier estimates of overall survival (OS) at interim analyses according to treatment group. (A) OS for full analysis set (patients receiving ≥ one dose of cyclophosphamide ); median OS was 6.0 months in group receiving Cy/GVAX followed by CRS-207 and 3.4 months in group receiving Cy/GVAX alone. (B) OS for per-protocol analysis set (patients receiving ≥ three doses [≥ two doses of Cy/GVAX and one dose of CRS-207 in arm A or three doses of Cy/GVAX in arm B]); median OS was 7.3 months in group receiving Cy/GVAX followed by CRS-207 and 4.6 months in group receiving Cy/GVAX alone. Solid circles represent censored survival time for alive patients.

11 april 2011: ik ben kanker-actueel aan het herzien en heb aan dit artikel toegevoegd dat de FDA betreffende het GVAX vaccin toestemming geeft voor verder onderzoek binnen de regeling weesmedicijnen. Onderaan artikel staat deel van persbericht over dit onderzoek. 

27 augustus: Bron Dow: Een vaccin uit de GVAX groep van Cellgenesys tegen alvleesklierkanker geeft hoop aldus resultaten uit een fase I trial. 14 patiënten kregen dit vaccin na de reguliere behandelingen als operatie en chemo c.q. bestraling. Alle patiënten hadden door aanwezigheid van uitgezaaide kankercellen in de lymfeklieren en bloed een sterk verhoogd risico op een recidief. Drie patiënten bleven kankervrij voor een periode nu al van 6,5 jaar en tonen alle drie in hun bloed sterke groei van specifieke T-immuuncellen. In 2005 worden de resultaten verwacht van een fase II trial bij 60 patiënten. Voor OPS-leden hebben we het adres van een contactpersoon bij Cellgenesys beschikbaar. Hier het persbericht via de DOW verkregen.

SOUTH SAN FRANCISCO, Calif., Aug. 19 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE) today announced the publication of encouraging immunologic data for GVAX(R) pancreatic cancer vaccine, a non patient-specific vaccine which is being developed as an "off-the-shelf" pharmaceutical product. In a previously reported Phase 1 trial of this product, 14 patients received the vaccine after pancreatic cancer surgery and standard adjuvant therapy. Three patients remain alive and disease-free at their most recent follow-up of at least 6.5 years. The newly published article describes a detailed analysis of the immune response to the vaccine product in these patients. Of particular note is that all three long-term survivors demonstrated strong T cell responses to mesothelin, a tumor-associated molecule found on GVAX(R) pancreatic cancer vaccine cells, and that the specificity of the T cell response to mesothelin was unique to each responding patient. In contrast, only one of the 11 patients who progressed and died from pancreatic cancer mounted a detectable immune response to mesothelin and the level of response in this patient was minimal by comparison. These findings provide evidence that patient-specific immune responses can be generated following vaccination with a non patient-specific GVAX(R) cancer vaccine product and that such responses may correlate with clinical outcome. The results were published in an August issue of the Journal of Experimental Medicine by Elizabeth Jaffee, M.D., professor of Oncology, and colleagues at the Johns Hopkins Kimmel Cancer Center.
"These newly published results provide compelling evidence in humans that a non patient-specific GVAX(R) vaccine product can be used to generate antitumor immunity, with a profile specific to each vaccinated patient," said Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "Such findings are important because they provide further scientific proof-of-concept for our GVAX cancer vaccine strategy, which is focused on non patient-specific, "off-the-shelf" products. For example, our GVAX(R) prostate cancer vaccine, which is currently in Phase 3 clinical trials, is a non patient-specific vaccine product."

The initial Phase 1 trial of GVAX(R) pancreatic cancer vaccine was conducted at the Johns Hopkins Kimmel Cancer Center in 14 patients who received the vaccine following surgical resection of their tumor and standard adjuvant radiation and chemotherapy. As first reported in the Journal of Clinical Oncology in January 2001, three of eight patients who received the higher dose levels of the vaccine had prolonged disease-free survival and this continues to be true at their most recent follow-up of at least 6.5 years. This outcome is considered particularly significant since all three long-term survivors were judged to be at high risk for recurrent cancer due to microscopic evidence of pancreatic tumor following surgery and/or metastatic tumor in pancreatic lymph nodes. In addition, the three patients with prolonged disease-free survival had biopsy-proven vaccine-induced antitumor immunity as well as delayed type sensitivity (DTH) reactions against their own tumor cells, findings not seen in the patients whose cancer progressed. This observed relationship between evidence of an immune response to the vaccine and clinical outcome is further supported by T cell responses to mesothelin described in the Journal of Experimental Medicine article. As with other GVAX(R) clinical trials, vaccine treatment was generally well tolerated.

A follow-on Phase 2 clinical trial of GVAX(R) pancreatic cancer vaccine in patients with operable pancreatic cancer who receive the vaccine after surgical resection of tumor and adjuvant radiation chemotherapy is currently being conducted at the Johns Hopkins Kimmel Cancer Center. To date, the study has enrolled approximately 50 out of a projected 60 patients. Enrollment is expected to be completed this year, in which case preliminary data may be available during 2005.

Clinical trials of GVAX(R) cancer vaccines are under way for multiple types of cancer in addition to pancreatic cancer, including prostate cancer, lung cancer, leukemia and myeloma. GVAX(R) vaccines are whole-cell vaccines that are designed to stimulate an immune response against the patient's tumor. The vaccines are comprised of tumor cells that have been genetically modified to secrete GM-CSF, an immune stimulatory hormone that plays a key role in stimulating the body's immune response to vaccines. Currently, Cell Genesys is developing non patient-specific, "off-the-shelf" GVAX(R) vaccines for prostate cancer, pancreatic cancer, leukemia and myeloma, and a patient-specific, individualized vaccine for lung cancer. GVAX(R) cancer vaccines have demonstrated a favorable side effect profile in over 600 patients treated in clinical trials to date.

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is pursuing three cancer product platforms -- GVAX(R) cancer vaccines, oncolytic virus therapies and antiangiogenesis therapies. Clinical trials of GVAX(R) cancer vaccines include an ongoing Phase 3 trial of GVAX(R) prostate cancer vaccine as well as trials of GVAX(R) vaccines for lung cancer, pancreatic cancer, leukemia and myeloma. Clinical programs of oncolytic virus therapies include CG7870 for prostate cancer. Preclinical studies are in progress for additional GVAX(R) cancer vaccines, oncolytic virus therapies and antiangiogenesis therapies for multiple types of cancer. Cell Genesys' minority-owned subsidiary, Ceregene, Inc., is focused on gene therapies for neurologic disorders. Cell Genesys also continues to hold an equity interest in its former subsidiary, Abgenix, Inc., an antibody products company. Cell Genesys is headquartered in South San Francisco, CA and has manufacturing operations in San Diego, CA, Hayward, CA and Memphis, TN. For additional information, please visit the company's website.

FDA geeft toestemming voor verder onderzoek van GVAX vaccin bij alvleesklierkanker

Bron: Fiercebiotech.com

BioSante Announces FDA Orphan Drug Designation for GVAX Pancreatic Cancer Vaccine

LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced BioSante's receipt of Orphan Drug designation from the FDA's Office of Orphan Products Development for GVAX Pancreas Vaccine in the treatment of pancreatic cancer.

"The Orphan Drug designation of GVAX Pancreas Vaccine for the treatment of pancreatic cancer is BioSante's first GVAX regulatory submission and response from the FDA since acquiring this portfolio of cancer vaccines last October"
"The Orphan Drug designation of GVAX Pancreas Vaccine for the treatment of pancreatic cancer is BioSante's first GVAX regulatory submission and response from the FDA since acquiring this portfolio of cancer vaccines last October," said Stephen M. Simes, BioSante's president & CEO. "It is our intention to find ways to continue the development of our GVAX Pancreas Vaccine using the benefits conferred by gaining Orphan Drug designation. Further, this designation alerts the FDA that we are dedicated to bringing better cancer therapy to patients in need. Currently, GVAX Pancreas Vaccine clinical trials are ongoing at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. In addition, clinical trials of GVAX vaccines against many different cancer types are being conducted, including leukemia and breast cancer. We value our collaborative relationship with the researchers at the Cancer Center and intend to work with them to advance the development of these potentially life-saving therapies."

Read more: BioSante Announces FDA Orphan Drug Designation for GVAX Pancreatic Cancer Vaccine - FierceBiotech http://www.fiercebiotech.com/press-releases/biosante-announces-fda-orphan-drug-designation-gvax-pancreatic-cancer-vaccine#ixzz1JCmkXOQq

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