Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. To learn more about Roswell Park Comprehensive Cancer Center and the Roswell Park Care Network, visit call 1-800-ROSWELL (1-80) or email AmpligenĪmpligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system.
Founded in 1898, Roswell Park was among the first three cancer centers nationwide to become a National Cancer Institute-designated comprehensive cancer center and is the only one to hold this designation in Upstate New York. Driven to eliminate cancer’s grip on humanity, the Roswell Park team of 4,000 makes compassionate, patient-centered cancer care and services accessible across New York State and beyond. Tumor and blood biomarkers were also analyzed in exploratory studies.įor more information about the Phase 1 study, visit : NCT04081389.Ībout Roswell Park Comprehensive Cancer Centerįrom the world’s first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated and prevented worldwide. Secondary endpoints included pCR rate where 5/9 (56%) of patients attained pCR and 1 more patient attained ypTmic. DLT was defined as grade 3 or higher toxicities within the first 3 weeks. The results demonstrated that treatment was well-tolerated with mostly grade 1 or 2 treatment-related adverse events (TRAEs) without dose-limiting toxicities (DLTs) or delayed or immune-related toxicities. The primary endpoint of the study was safety and tolerability. CKM/paclitaxel was followed by standard dose-dense doxorubicin and cyclophosphamide (AC) and surgery. IFN-α2b was administered in an accelerated dose-escalation at 0 or 5 million units (MU)/m2 in the first 2 patients 10 MU/m2 in 4 patients and 20 MU/m2 in 3 patients. In the Phase 1 study, 9 patients with stage I-III TNBC, median age 47 (37-55) years, were treated with paclitaxel 80 mg/m2 IV weekly for 12 weeks and CKM for the first 3 weeks, days 1-3 (IV Ampligen 200 mg daily and oral celecoxib 200 mg twice daily). We continue to be encouraged by Ampligen’s demonstrated potential to deliver promising clinical activity in an area where there remain significant immune-related toxicities with the current standard of care and look forward to its continued development,” stated David Strayer, MD, AIM’s Chief Scientific and Medical Officer.
“We are pleased to bolster our growing body of data from Ampligen and the results demonstrated in the Phase 1 study with the completed topline data report now in hand. The now completed topline results from the Phase 1 study confirm the positive findings that were previously presented at the 2022 Society for Immunotherapy of Cancer (SITC) 37 th Annual Meeting in a poster presentation titled Safety and efficacy of de-escalated neoadjuvant chemoimmunotherapy of triple negative breast cancer (TNBC) using chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib). The research was led by Roswell Park Comprehensive Cancer Center medical oncologist Shipra Gandhi, MD, a physician scientist who is Assistant Professor of Oncology at Roswell Park, in collaboration with senior investigator Pawel Kalinski, MD, PhD, Chair of Immunology and Senior Vice President for Team Science at Roswell Park. The complete topline results are now available on : NCT04081389. (NYSE American: AIM) (“AIM” or the “Company”) today announced that Roswell Park Comprehensive Cancer Center has reported the complete topline data from its Phase 1 study evaluating Ampligen ® (rintatolimod) as a component of a CKM regimen for the treatment of early-stage triple negative breast cancer (TNBC). 11, 2023 (GLOBE NEWSWIRE) - AIM ImmunoTech Inc. Planned Phase 2 study in early-stage TNBC to determine if CKM including Ampligen may be a safe and effective alternative to pembrolizumab or in addition to pembrolizumab/NAC Complete topline results confirm treatment was well tolerated, with promising clinical activity of pathologic complete response (pCR) + microinvasive residual disease (ypTmic) at 66%, comparable to pembrolizumab/neoadjuvant chemotherapy (NAC)
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