NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE:PFE) announced today that the Phase 2b trial STRIVE (STaphylococcus
aureus SuRgical Inpatient Vaccine Efficacy) evaluating the company’s
investigational Staphylococcus aureus (S. aureus)
multi-antigen vaccine (PF-06290510) is being discontinued due to
futility. This decision is based on a recommendation from an independent
Data Monitoring Committee (DMC), composed of external experts, after
conducting a pre-planned interim analysis.
The DMC concluded from these data that the study reached futility,
meaning that there is low statistical probability for the study to meet
the pre-defined primary efficacy objective in adults undergoing elective
spinal fusion surgery after completing a planned Phase 3 expansion of
the study.
A safety review by the DMC indicated that the investigational vaccine
has been safe and well tolerated. STRIVE trial participants who are
enrolled in the study will complete the study’s follow-up evaluations.
Pfizer is evaluating next steps for the potential development of a S.
aureus vaccine.
About Pfizer Inc.: Working together for a healthier world
®
At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world’s
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For more
than 150 years, we have worked to make a difference for all who rely on
us. We routinely post information that may be important to investors on
our website at www.pfizer.com.
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PFIZER DISCLOSURE NOTICE:
The information contained in
this release is as of December 20, 2018. Pfizer assumes no obligation to
update forward-looking statements contained in this release as the
result of new information or future events or developments.
This release contains forward-looking information about Pfizer’s
discontinuation of the Phase 2b trial STRIVE (STaphylococcus aureus
SuRgical Inpatient Vaccine Efficacy) evaluating the company’s
investigational Staphylococcus aureus (S. aureus)
multi-antigen vaccine candidate, PF-06290510, that involves substantial
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties inherent in
research and development, including the ability to meet anticipated
clinical study commencement and completion dates and regulatory
submission dates, as well as the possibility of unfavorable study
results, including unfavorable new clinical data and additional analyses
of existing clinical data; continuing evaluation of the estimated costs
and benefits associated with the PF-06290510 program or discontinuation
of the STRIVE study; further analysis of data from the STRIVE trial as
well as other trials of PF-06290510; potential impact of unanticipated
costs, expenses, and liabilities; and risks and uncertainties generally
characterizing developing new biopharmaceutical products, including
those described under the heading “Risk Factors” in Pfizer’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2017, which
may be found at www.sec.gov
and www.pfizer.com.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended December
31, 2017 and in its subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results,” as well as in
its subsequent reports on Form 8-K, all of which are filed with the U.S.
Securities and Exchange Commission and available at
www.sec.gov
and
www.pfizer.com
.
View source version on businesswire.com:
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Media: Jessica Smith
O: 212-733-6213
E: Jessica.M.Smith@pfizer.com
Investor Relations: Ryan Crowe
O: 212-733-8160
E: Ryan.Crowe@pfizer.com
Source: Pfizer Inc.