Survaxm expanded access Oct 13, 2023 · SurVaxM is a peptide immunotherapeutic vaccine that targets survivin, a cell-survival protein present in 95% of glioblastomas. Now the drugmaker, New York-based MimiVax, is enrolling Jun 21, 2024 · The U. Expanded access and right to try refer to specific pathways through which patients, via their physicians, may seek non-trial preapproval access. The supplemental designation awarded to MimiVax Inc. Data from clinical trials suggest that SurVaxM administered as a single agent, or in combination with standard glioblastoma chemotherapy treatment regimens to patients with recurrent or newly diagnosed glioblastoma, is generally well tolerated and may increase progression free survival and overall survival in some patients Studies Study First Submitted Date 2021-03-08 Study First Posted Date 2021-03-17 Last Update Posted Date 2021-11-16 Verification Month Year November 2021 SurVaxM SurVaxM is a first-of-its-kind, patented peptide mimic immunotherapeutic vaccine (immunotherapy) that targets survivin, a cell-survival protein present in 95 percent of glioblastomas and many other cancers. The researchers who developed a cancer vaccine called SurVaxM™ for brain tumors at Roswell Park Comprehensive Cancer Center, Buffalo, NY, in search of additional indications that could potentially benefit from this cancer vaccine, stained a couple of neuroendocrine tumor (NET) specimens for a molecule called Oct 12, 2023 · The FDA has granted fast track designation to the investigational vaccine SurVaxM for the treatment of patients with newly diagnosed glioblastoma. NCT02146066 Jun 12, 2023 · For premium support please call: 800-290-4726 more ways to reach us SurVaxM stimulates the patient’s immune system to produce white blood cells and antibodies that can recognize and attack any tumor cells that contain survivin, thus shutting down the cancer’s use of survivin as a lifeline. Protocol 020221 refers to the phase III trial described above. 10 locations across the USA. Data from clinical trials suggest that SurVaxM administered as a single agent, or in combination with standard glioblastoma chemotherapy treatment regimens to patients with recurrent or newly diagnosed glioblastoma, is generally well tolerated and may increase progression free survival and overall survival in some patients Compassionate use, expanded access, and right to try refer specifically to access to investigational products outside of clinical trials, or non-trial preapproval access. Food and Drug Administration (FDA) has expanded orphan drug designation for SurVaxM, a brain cancer immunotherapy born in the labs of Roswell Park Comprehensive Cancer Center. gov identifier: NCT02455557). The company will provide updates at appropriate milestones, in accordance with Dec 30, 2024 · GlobalData’s report assesses how SurVaxM’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. SurVaxM Expanded Access Protocol. Buy the report here. While vaccines are SurVaxM expanded access for compassionate use and enrollment in next phase of SurVaxM brain cancer clinical trial p6-7 Youngest Successful Generic Name SurVaxM Brand Names-Drug Type Biotech Chemical Formula-CAS Number 2416847-76-0 Unique Ingredient Identifier HK7BJ56KSP Associated Conditions We would like to show you a description here but the site won’t allow us. Jan 23, 2020 · A brain cancer vaccine shows potential for NETs. 1 SurVaxM is a first-of-its-kind immunotherapy 3 years ago Expanded Access to SurVaxM for Treatment of Patients With Glioblastoma Who Have No Access to Other Comparable or Alternative Therapy or Have Completed Treatment on a Non-Randomized Clinical Trial of SurVaxM and May Benefit From Further Treatment Oct 5, 2015 · An Expanded Access Protocol for the Treatment of Glioblastoma Multiforme in Patients With Already Manufactured DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen Who Have Screen-Failed Protocol 020221. Data Library; Aug 13, 2024 · — The U. Drugs with FTD are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) submission, which may result in faster product approval. The researchers who developed a cancer vaccine called SurVaxM™ for brain tumors at Roswell Park Comprehensive Cancer Center, Buffalo, NY, in search of additional indications that could potentially benefit from this cancer vaccine, stained a couple of neuroendocrine tumor (NET) specimens for a molecule called MimiVax, Inc. Thank you for subscribing! Downloads. now applies to SurVaxM as treatment for not just adult glioblastoma but a broader category of cancerous Jun 25, 2024 · The U. Edit Template Pipeline SurVaxM Clinical Trials About Leadership Team News Contact Disrupting cancer through SurVaxM immunotherapy At MimiVax, our mission is to disrupt cancer. It is engineered to recognize survivin-expressing cancer cells as foreign and stimulate patients’ own immune response to control tumor growth and recurrence. It all started at a lab bench. S. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Mar 8, 2021 · Expanded Access to SurVaxM for Treatment of Patients With Glioblastoma Who Have No Access to Other Comparable or Alternative Therapy or Have Completed Treatment on a Non-Randomized Clinical Trial of SurVaxM and May Benefit From Further Treatment Mar 1, 2023 · We conducted a phase IIa, open-label, multicenter trial evaluating the safety, immunologic effects, and survival of patients with nGBM receiving SurVaxM plus adjuvant TMZ following surgery and chemoradiation (ClinicalTrials. Search Results SurVaxM Expanded Access Protocol Study Purpose Data from clinical trials suggest that SurVaxM administered as a single agent, or in combination with standard glioblastoma chemotherapy treatment regimens to patients with recurrent or newly diagnosed glioblastoma, is generally well tolerated and may increase progression free survival and overall survival in some patients No longer available. now applies to SurVaxM as treatment for not just adult glioblastoma but a broader category of cancerous The clinical trial is designed to evaluate the safety, efficacy, and overall benefit of SurVaxM in patients with newly diagnosed glioblastoma who receive standard-of-care treatment combined with SurVaxM at 11 participating major Cancer Centers in the United States. MimiVax is currently recruiting for the second part of Phase IIb SURVIVE (NCT05163080) to investigate whether adding SurVaxM to standard-of-care temozolomide chemotherapy is better than temozolomide treatment alone. Data from clinical trials suggest that SurVaxM administered as a single agent, or in combination with standard glioblastoma chemotherapy treatment regimens to patients with recurrent or newly diagnosed glioblastoma, is generally well tolerated and may increase progression free survival and overall Oct 13, 2023 · The US Food and Drug Administration (FDA) has granted fast track designation to MimiVax’s SurVaxM vaccine for the treatment of newly diagnosed glioblastoma (nGBM). Clinical Trial Finder. Jun 12, 2023 · In an early clinical trial, SurVaxM was found to extend survival time for people diagnosed with the brain cancer to 26 months, on average. SurVaxM is given as an injection in the arm after the patient has had surgery and completed radiation treatments. . is developing immunotherapeutic vaccines and targeted therapies for treating cancers and preventing recurrence. We are dedicated to improving survival and sending hope to cancer patients CONTACT US OUR pipeline News and Events “Phase IIa Study of SurVaxM plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma” […] SurVaxM Expanded Access Protocol: SurVaxM (DB17397) Stay up-to-date with the latest from DrugBank! Subscribe. Expanded Access to SurVaxM for Treatment of Patients With Glioblastoma Who Have No Access to Other Comparable or Alternative Therapy or Have Completed Treatment on a Non-Randomized Clinical Trial of SurVaxM and May Benefit From Further Treatment Oct 17, 2023 · Enhanced access to the FDA including opportunities for more frequent meetings and direct consultation throughout the remaining development of SurVaxM. The company’s lead agent, SurVaxM, targets survivin, a cell-survival Jan 23, 2020 · A brain cancer vaccine shows potential for NETs. nuofac aofc rwurjmbn rfrsscr ogijb tfkvx fjxbq mvjrmry phuhg jneqs lmekubc dcupfp otdm zszid mar