Vical and Astellas Announce Topline Results from a Phase 2 Study of Investigational Cytomegalovirus (CMV) Vaccine (ASP0113) i...
September 19 2016 - 6:30AM
Vical Incorporated (Nasdaq:VICL) and Astellas Pharma Inc.
(TOKYO:4503) today announced topline results from a randomized,
double-blind, placebo-controlled Phase 2 study evaluating the
safety and efficacy of cytomegalovirus (CMV) vaccine, ASP0113,
versus placebo in kidney transplant patients receiving an organ
from a CMV-seropositive donor. Results from the study demonstrated
that the trial did not meet its primary endpoint, which was the
proportion of patients having CMV viremia defined as a plasma viral
load of ≥ 1000 IU/mL by central laboratory assay through one year
after first injection of study drug. Additionally, the secondary
endpoints of CMV-associated disease and CMV-specific antiviral
therapy, which were evaluated by an independent, blinded
Adjudication Committee, were similar in both treatment groups.
The safety profiles were generally similar between treatment
groups. However, local injection site reactions were more common in
the ASP0113 treatment group. Further detailed data from the trial
is expected to be disclosed at an upcoming scientific congress.
"The unmet medical need in addressing CMV infection in
transplant patients remains high. Although we had hoped for a
different outcome, we look forward to further analyzing these data
in hopes of contributing knowledge to the future development
programs in this patient population,” said Bernhardt G. Zeiher,
M.D., President, Development, Astellas. “In addition, we continue
to focus on execution of our Phase 3 study in hematopoietic cell
transplant (HCT) recipients and are pleased to announce that we
have met our target enrollment.”
“We are pleased with our collaborative relationship with
Astellas, and we look forward to the results from the pivotal Phase
3 study in HCT recipients, which we expect to obtain during the
fourth quarter of 2017,” said Vijay Samant, President and Chief
Executive Officer, Vical.
About the StudyThe randomized, double-blind,
placebo-controlled trial evaluated the safety and efficacy of
ASP0113 in CMV-seronegative kidney transplant recipients receiving
an organ from a CMV-seropositive donor (D+/R-). Enrollment included
150 kidney transplant recipients across approximately 80 centers in
North America, Europe and Australia and randomized 1:1 to receive
either ASP0113 or placebo, in addition to valganciclovir or
ganciclovir prophylaxis for 100 days after kidney transplant.
About ASP0113ASP0113 is a vaccine designed to
prevent CMV disease and associated complications in SOT and HCT
recipients. The bivalent DNA vaccine encodes 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 and is now in partnership with Astellas for further
development and commercialization. ASP0113 has received Orphan Drug
Designation in the United States and Europe for the prevention of
CMV disease in SOT and HCT recipients. The ongoing Phase 3 trial of
ASP0113 in HCT recipients represents the first time a CMV vaccine
or a DNA vaccine has entered Phase 3 testing in a registrational
trial.
About CMVCMV is a herpes virus that infects
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 SOT recipients, as well as infants
born to mothers who first become infected during pregnancy.
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
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.
Vical Forward-Looking StatementsThis press
release contains forward-looking statements subject to risks and
uncertainties that could cause actual results to differ materially
from those projected. Forward-looking statements include
anticipated developments in collaborative programs, including the
timing of data from the pivotal Phase 3 study of ASP0113 in HCT
recipients. Risks and uncertainties include whether Vical or others
will continue development of ASP0113; whether any product
candidates will be shown to be safe and efficacious in clinical
trials; whether Vical is able to continue its collaborative
arrangements or enter into new ones; the timing of clinical trials;
whether Vical or its collaborative partners will seek or gain
approval to market any product candidates; and additional risks set
forth in the Company's filings with the Securities and Exchange
Commission. These forward-looking statements represent the
Company's judgment as of the date of this release. The Company
disclaims, however, any intent or obligation to update these
forward-looking statements.
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:
Vical Inc.
Andrew Hopkins
+1 (858) 646-1127
www.vical.com
Astellas Pharma Inc.
Corporate Communications
+81 (3) 3244-3201
www.astellas.com/en
Astellas U.S. Media Inquiries
Stefanie Prodouz
+1 (224) 205-5943
Stefanie.Prodouz@astellas.com
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