TOKYO and SAN DIEGO, Jan. 22,
2018 /PRNewswire/ -- Astellas Pharma Inc. (TSE:
4503, President and CEO: Yoshihiko
Hatanaka, "Astellas") and Vical Incorporated (NASDAQ: VICL)
announced today that ASP0113, an investigational DNA vaccine being
developed for cytomegalovirus (CMV)-seropositive hematopoietic stem
cell transplant (HSCT) recipients, did not meet its primary or
secondary endpoints in the Phase 3 HELIOS clinical trial. The
vaccine was generally well tolerated, with injection-site reactions
being the most commonly reported adverse event.
"We are disappointed that the results did not demonstrate a
significant improvement in overall survival and reduction in CMV
end-organ disease," said Bernhardt G.
Zeiher, president of Development, Astellas. "We would like
to thank the patients and clinicians who participated in this
important trial."
The Phase 3 trial was designed to evaluate the efficacy of
ASP0113 compared with placebo in CMV-seropositive recipients
undergoing an allogeneic stem cell transplant. Efficacy was
assessed using a primary composite endpoint of overall mortality
and CMV end-organ disease through the first year following the
transplant, an endpoint which was not met. Secondary endpoints of
time to first protocol-defined CMV viremia and time to first use of
adjudicated CMV-specific antiviral therapy also were not met.
"The Phase 3 trial outcome is disappointing," said Vijay Samant, Vical's Chief Executive Officer.
"Astellas and Vical employees, the investigators and study site
personnel did an outstanding job conducting this study, but
unfortunately, the vaccine was unable to provide protection against
all-cause mortality in this very difficult-to-treat patient
population."
The Phase 3 trial was a 1:1 randomized, double-blind,
placebo-controlled study that enrolled a total of 514 CMV
seropositive subjects undergoing hematopoietic stem cell
transplantation. Randomization was stratified by donor-recipient
relatedness and donor CMV serostatus. Subjects were followed for
one year post-transplant. For more information about the ASP0113
clinical trial, please visit www.clinicaltrials.gov.
About Cytomegalovirus
CMV is a herpes virus that is
estimated to infect more than half of all adults in the United States by age 50, and is even more
widespread in developing countries. A healthy immune system
typically protects an infected person against CMV disease, but does
not prevent or clear latent infection. Individuals whose immune
systems are not fully functional are at high risk of CMV
reactivation, potentially leading to severe illness or death. Those
at greatest risk include HCT and solid-organ transplant recipients,
as well as infants born to mothers who first become infected during
pregnancy.
About ASP0113
ASP0113 is an investigational
vaccine candidate designed to prevent CMV disease and associated
complications in CMV-seropositive HCT recipients. ASP0113 is a
bivalent DNA vaccine encoding CMV phosphoprotein 65 and
glycoprotein B antigens for induction of both cellular and humoral
immune responses, formulated with a proprietary poloxamer-based
delivery system. ASP0113 was initially developed by Vical which
partnered with Astellas for further development and
commercialization. ASP0113 received Orphan Drug Designation in
the United States and Europe.
About Astellas
Astellas Pharma Inc., based in
Tokyo, Japan, is a company
dedicated to improving the health of people around the world
through the provision of innovative and reliable pharmaceutical
products. We focus on Urology, Oncology, Immunology, Nephrology and
Neuroscience as prioritized therapeutic areas while advancing new
therapeutic areas and discovery research leveraging new
technologies/modalities. We are also creating new value by
combining internal capabilities and external expertise in the
medical/healthcare business. Astellas is on the forefront of
healthcare change to turn innovative science into value for
patients. For more information, please visit our website at
https://www.astellas.com/en.
About Vical
Vical develops biopharmaceutical products
for the prevention and treatment of chronic or life-threatening
infectious diseases, based on its patented DNA delivery
technologies and other therapeutic approaches. Additional
information on Vical is available at www.vical.com
Astellas Cautionary Notes
In this press release,
statements made with respect to current plans, estimates,
strategies and beliefs and other statements that are not historical
facts are forward-looking statements about the future performance
of Astellas. These statements are based on management's current
assumptions and beliefs in light of the information currently
available to it and involve known and unknown risks and
uncertainties. A number of factors could cause actual results to
differ materially from those discussed in the forward-looking
statements. Such factors include, but are not limited to: (i)
changes in general economic conditions and in laws and regulations,
relating to pharmaceutical markets, (ii) currency exchange rate
fluctuations, (iii) delays in new product launches, (iv) the
inability of Astellas to market existing and new products
effectively, (v) the inability of Astellas to continue to
effectively research and develop products accepted by customers in
highly competitive markets, and (vi) infringements of Astellas'
intellectual property rights by third parties.
Information about pharmaceutical products (including products
currently in development) which is included in this press release
is not intended to constitute an advertisement or medical
advice.
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