Data from Phase 1 Trial of Triplex Vaccine for Control of Cytomegalovirus Published in Blood
By ADVANCE Perspectives
Duarte, CA and New York, NY — City of Hope and Helocyte, Inc., a majority-owned subsidiary of Fortress Biotech, Inc. has announced that data from the Phase 1 trial of Helocyte’s Triplex vaccine were published online this month in Blood, the journal of the American Society of Hematology. The vaccine is initially being developed for control of cytomegalovirus (CMV) in allogeneic hematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT) recipients. In the Phase 1 study, Triplex was found to be safe, well-tolerated and highly immunogenic when administered to healthy volunteers at multiple dose levels. These data supported the initiation of an ongoing Phase 2 trial evaluating Triplex in patients undergoing allogeneic HSCT.
In the Phase 1 trial, City of Hope researchers studied the response to the vaccine in 24 healthy volunteers. They found that Triplex generated robust and durable virus-specific immunity in those previously infected with CMV (addressing patients at greatest risk of viral complications following allogeneic HSCT) as well as in those with no prior CMV infection (addressing patients at greatest risk of viral complications following SOT).
CMV can impede the recovery of patients undergoing HSCT for the treatment for certain blood or bone marrow cancers. The virus can be transmitted to seronegative transplant recipients through infected donor grafts, or reactivated in seropositive transplant recipients (particularly those with low baseline immunity) as a result of their immuno-suppressed condition. In either instance, CMV can cause severe and life-threatening complications, including pneumonia, gastroenteritis and retinitis. Triplex has the potential to benefit patients in numerous clinical settings since the immune response generated by most individuals to CMV is far greater than the response associated with any other virus or condition.
“After years of work, it is very gratifying that we are making advancements in helping people worldwide achieve better health outcomes after a transplant procedure,” said Don J. Diamond, PhD, chair of the Department of Experimental Therapeutics at City of Hope, who led the team that developed Triplex. “Furthermore, Triplex’s favorable safety and immunogenicity may make the vaccine an ideal therapeutic platform to combat significant complications in many disease areas, like solid organ transplant and glioblastoma,” Diamond said.
“We are pleased to announce the publication of these important data in Blood. CMV is a ubiquitous virus that causes life-threatening disease in those with weakened immune systems,” said Frank Taffy, co-founder, president, CEO and board member of Helocyte. “We look forward to a continued collaboration with City of Hope as we advance our ongoing Phase 2 in HSCT, and initiate studies of Triplex across multiple other indications,” said Mr. Taffy.
John A. Zaia, MD, director of City of Hope’s Center for Gene Therapy and the Aaron D. Miller and Edith Miller Chair in Gene Therapy, served as the Phase 1 trial’s principal investigator.
Research reported in the aforementioned Blood publication was supported by the National Cancer Institute of the National Institutes of Health.
For more information, please visit http://www.helocyte.com/ and http://www.fortressbiotech.com/.