According to a recent article in The Pharma Letter, the European Medicines Agency (EMA) granted PRIME (PRIority MEdicines) designation to Viralym-M based on positive results from a Phase 2 proof-of-concept (testing feasibility) study.
The study revealed that over ninety percent of trial participants, who had previously failed standard treatment, experienced a partial or complete response with Viralym-M. The majority of patients were relieved of their most severe clinical symptoms.
About Viralym-M
Viralym-M (ALVR105) is in clinical development as a “ready-to-administer” single T-cell product that targets the following viral pathogens simultaneously:
- BK virus
- Cytomegalovirus
- Adenovirus
- Epstein-Barr virus
- JC virus
- Human herpesvirus 6
Note that Viralym-M combats adenovirus resulting from allogeneic (from a donor) stem cell transplantation. About ninety percent of allogeneic stem cell transplantation patients will experience a virus post transplant. Two thirds may reactivate several viruses.
About AlloVir
AlloVir, an ElevateBio company, is focused on developing novel cell therapies that maintain and restore T-cell immunity in patients at high risk due to life-threatening viruses.
Both commercialization and worldwide development rights to Viralym-M have been secured by AlloVir.
Viralym-M is engineered to potentially treat hundreds of patients with virus-specific T-cells derived from one donor.
AloVir uses its own collection of donor cell lines which are matched to patients.
The U.S. FDA previously awarded AloVir’s Viralym-M the Regenerative Medicine Advanced Therapy designation specifically for treatment of hemorrhagic cystitis. The disease is caused by the BK virus, one of the complications of allogeneic stem cell transplantation.
The EMA’s PRIME Program
The program is designed to assist in optimizing therapeutic advantage over and above existing treatments. The goal is to benefit patients who do not have other options for treatment.
The designation is therefore awarded for medicines that satisfy unmet medical needs.
The EMA provides support to developers which includes dialogue and interaction plus a pathway to fast-track evaluation.
AlloVir/Viralym-M Plans for 2020
AlloVir has Viralym-M scheduled to be further tested in 2020 in a pivotal Phase 3 study and a proof-of-concept Phase 2 study that will target six common viral pathogens.
What are your thoughts about Viralym-M’s potential to restore integrity to the immune system? Share your stories, thoughts, and hopes with the Patient Worthy community!
