Astellas and Vical Announce Top-Line Results for Phase 3 Trial of Cytomegalovirus Vaccine ASP0113 in Hematopoietic Stem Cell...
January 22 2018 - 3:00AM
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 ASP0113ASP0113 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 AstellasAstellas 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 VicalVical 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 NotesIn
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.
Contacts for inquiries or additional
information:
Astellas:U.S. Media inquiries: Candace
JohnsonTEL: +1-224-205-5735 E-MAIL:
candace.johnson@astellas.com
Japan Media and Investor Relations inquiries: TEL:
+81-3-3244-3201 FAX: +81-3-5201-7473
Vical: Media inquiries: Andrew Hopkins TEL:
+1-858-646-1127 E-MAIL: AHopkins@vical.com
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