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Among the 23 high-risk allogeneic hematopoietic cell transplant patients in this analysis, no end-organ viral diseases were observed
Of the 13 patients who completed the primary endpoint at week 14, 11 still had no clinically significant infections
The strength of these preliminary efficacy and safety data supports the advancement of posoleucel to the Phase 3 registration trial that is expected to start in the first half of 2022
The company will hold a virtual investor event on December 13
AlloVir (Nasdaq stock code:ALVR), a clinically advanced allogeneic T-cell immunotherapy company, today announced preliminary data from the open-label portion of a phase 2 study that assessed the safety of posoleucel (Viralym-M, ALVR105) to prevent clinical significance Sex and effectiveness six potentially life-threatening viral infections and end-organ diseases among high-risk patients after allo-HCT. Among the 23 patients who received at least one dose of posoleucel in the ongoing study, including those who completed, discontinued, or continued to use posoleucel, only 3 clinically significant infections were observed during the 14th week. As of the end of the study, there were no The patient developed end-organ viral disease. The data for this preliminary analysis is closed. Of the 13 patients who passed the primary endpoint at week 14, 11 still had no clinically significant infections. These preliminary results indicate that the expected incidence of clinically significant viral infections or diseases in this high-risk patient group has been greatly reduced. Repeated administration of posoleucel is generally well tolerated. These data were announced today at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition.
Based on preliminary data from the second phase of the study, the US Food and Drug Administration (FDA) agreed in principle to the company’s plan to advance from the second phase of the open label study to the third phase of the registration trial. The company plans to initiate the study in the first half of 2022 after the FDA reviews the final agreement.
Posoleucel is the company’s main research product. It is an allogeneic, off-the-shelf virus-specific T cell (VST) therapy. It is being evaluated for the prevention of six potentially life-threatening viruses that usually affect patients with allogeneic HCT-adenocarcinoma Virus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpes virus-6 (HHV-6) and JC virus (JCV). Nearly 90% of allo-HCT patients will reactivate at least one of these viruses after allo-HCT, and about two-thirds of these patients will reactivate multiple viruses. According to an analysis of peer-reviewed published data and electronic medical record reviews, approximately 70% of high-risk allo-HCT patients develop clinically significant infections or end organs due to one or more of these viruses after allo-HCT disease. Currently, there is no effective preventive treatment that can target these multiple viruses at the same time, leading to severe and long-term morbidity, hospitalization, and premature death.
“Viral infections often occur after allogeneic hematopoietic cell transplantation, which usually leads to serious complications, which may be life-threatening and have a negative impact on the survival of the patient. The side effects of antiviral drugs often complicate the treatment, and these drugs cannot solve the fundamental problem. The problem-immunodeficiency status,” said Sanjeet Dadwal, MD, director of the infectious disease department, professor of medicine in the City of Hope and research investigator of posoleucel. “Posoleucel has the potential to solve the underlying immunodeficiency that makes these patients vulnerable to viral infection…
The full story can be found on Benzinga.com
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