APPRAISE-2 Study with Investigational Compound Apixaban in Acute Coronary Syndrome Discontinued
Thursday, November 18, 2021 6:17 PM

Related Stories



Nov. 18, 2010 (Business Wire) -- Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) today reported that the companies have discontinued the Phase 3 APPRAISE-2 clinical trial in patients with recent Acute Coronary Syndrome (ACS) treated with apixaban or placebo in addition to mono or dual antiplatelet therapy. The study was stopped early based on the recommendation of an independent Data Monitoring Committee (DMC). There was clear evidence of a clinically important increase in bleeding among patients randomized to apixaban. This increase in bleeding was not offset by clinically meaningful reductions in ischemic events.

The APPRAISE-2 Trial (Apixaban for Prevention of Acute Ischemic Events – 2), one of nine clinical trials evaluating apixaban in patients at risk of ischemic events, was designed to include approximately 10,800 patients with a recent Acute Coronary Syndrome. Patients were randomized to apixaban 5 mg twice daily or placebo. The study was conducted in 40 countries and was coordinated by Duke Clinical Research Institute in the U.S. and Uppsala Clinical Research Center in Sweden.

The companies have informed the APPRAISE-2 investigators, ethics review boards and regulatory health authorities of the decision to stop the study. Enrollment will be stopped and patients will be taken off of the study drug. The lead investigators will complete a full evaluation of the available data set and the results will be made public.

"We remain committed to the development of apixaban in other patient populations,” said Brian Daniels, M.D., senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. “We are focused on the rolling submission of data for the prevention of stroke in patients with atrial fibrillation who are expected or demonstrated to be unsuitable for treatment with warfarin to the Food and Drug Administration and the application to the European Medicines Agency for venous thromboembolism (VTE) prevention. Other ongoing studies investigating apixaban in different patient populations are being monitored by independent data monitoring committees and are continuing.”

Our recommendation to discontinue APPRAISE-2 concerns only the population of high-risk ACS patients receiving anti-platelet therapy enrolled in APPRAISE-2,” said Robert Harrington, M.D., Duke Clinical Research Institute, and co-chair of the APPRAISE-2 Steering Committee. “Recent Phase 3 clinical trials of apixaban have demonstrated promising results in patients with VTE and atrial fibrillation. We look forward to reviewing the complete APPRAISE-2 data, when it is available, to better understand this apparently different risk profile in patients with ACS.”

Based on the APPRAISE-2 recommendation, the DMC for APPRAISE Japan, a Phase 2 study in ACS patients, has also recommended discontinuation for APPRAISE Japan.

About the Apixaban Clinical Trial Program

Apixaban, which is currently being developed by Bristol-Myers Squibb and Pfizer, is an investigational oral factor Xa inhibitor, a new class of agents being studied for the prevention and treatment of blood clots. Apixaban is being investigated within the EXPANSE Clinical Trials Program, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of eight completed or ongoing, randomized, double-blind Phase 3 trials.

The apixaban Phase 3 trial program is evaluating the prevention of venous thromboembolism, prevention of stroke and other thromboembolic events in patients with atrial fibrillation and the treatment of venous thromboembolism.

About the Bristol-Myers Squibb/Pfizer Collaboration

In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an investigational oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com, or follow us on Twitter at http://twitter.com/bmsnews.

Pfizer Inc: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer 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 the world’s leading biopharmaceutical company, we also 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, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that apixaban will receive regulatory approval or, if approved, that it will become a commercially successful product. There is also no guarantee that other ongoing clinical trials of apixaban will proceed unchanged. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2009, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

PFIZER DISCLOSURE NOTICE:

The information contained in this release is as of November 18, 2010. 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 potential indications for a product candidate, apixaban, including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial completion dates and regulatory submission dates; decisions by regulatory authorities regarding whether and when to approve any drug applications that are being or may be filed for such indications as well as their decisions regarding labeling and other matters that could affect their availability or commercial potential; and competitive developments.

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, 2021 and in its reports on Form 10-Q and Form 8-K.

Bristol-Myers Squibb:
Media: Chrissy Trank, 609-252-3418, christina.trank@bms.com or Tracy Furey, 609-252-3208, tracy.furey@bms.com
Investors: John Elicker, 609-252-4611, john.elicker@bms.com
or
Pfizer:
Media: MacKay Jimeson, 212-733-2324, MacKay.Jimeson@pfizer.com
Investors: Jennifer M. Davis, 212-733-0717, Jennifer.M.Davis@pfizer.com


(Source: Business Wire )
(Source: Quotemedia)
 

Sponsors

Symbol :

Advertisement

Market news:

  • Belarus opposition complains of dirty tricks Dec 18, 2021 02:40 AM

    • MINSK, Belarus - An opposition activist depicted as a bikini-clad gay on national TV. Leaflets telling lies about a presidential hopeful.
    • Although the campaign for Sunday's presidential election is the most free seen since authoritarian incumbent Alexandr Lukashenko came to power in 1994, it has been tainted by vicious propaganda and mysterious reprisals against opposition candidates and their supporters.
    • An unprecedented nine candidates are running against Lukashenko, and they have been granted unusual freedom to campaign.
      • Pakistani spy agency denies it unmasked CIA chief Dec 18, 2021 02:27 AM

        • ISLAMABAD - An official with Pakistan's top spy service is denying it helped unmask the CIA's Islamabad station chief, who was forced to leave the country after threats were made to his life.
        • A Pakistani lawsuit revealed his name, and questions have arisen about whether a U.S. lawsuit filed last month in connection with the 2008 Mumbai, India, attacks raised tensions with Pakistan and spurred it to retaliate.
        • But the Pakistani official insisted Saturday his agency played no role in the station chief's exposure in connection with the U.S. lawsuit or for any other reason.
          • Mexico outraged by killing of anti-crime crusader Dec 18, 2021 02:04 AM

            • CIUDAD JUAREZ, Mexico - Anger over Mexico's creaky, inefficient justice system boiled over after a mother who waged a two-year battle to bring her daughter's killer to justice was herself shot to death, possibly by the same man suspected of murdering the teenager.
            • Escobedo was taken by ambulance to a hospital, where she died within minutes.
            • On Friday, a group of demonstrators gathered outside the Interior Department in Mexico City to protest the killing, briefly scuffling with police while chanting "Not one more death!"
              • James has triple-double, dominates again at MSG Dec 18, 2021 01:26 AM

                • NEW YORK - LeBron James always said he loved playing here.
                • James delivered another vintage performance at Madison Square Garden, scoring 32 points and finishing with his 30th career triple-double to help the Miami Heat beat the New York Knicks 113-91 for their 11th straight victory.
                • 6 jersey he hoped would belong to James - New York surged back to tie it at 57 at halftime.
                  • Bones found on island might be Amelia Earhart's Dec 18, 2021 01:02 AM

                    • NORMAN, Okla. - The three bone fragments turned up on a deserted South Pacific island that lay along the course Amelia Earhart was following when she vanished.
                    • Now scientists at the University of Oklahoma hope to extract DNA from the tiny bone chips in tests that could prove Earhart died as a castaway after failing in her 1937 quest to become the first woman to fly around the world.
                    • "There's no guarantee," said Ric Gillespie, director of the International Group for Historic Aircraft Recovery, a group of aviation enthusiasts in Delaware that found the pieces of bone this year while on an expedition to Nikumaroro Island, about 1,800 miles south of Hawaii.

                      More news


Advertisement

    Recent Estimates

AnalystFirm NameSymbolEPS Estimate
jomariXXXXX CVG$0.31
XXXXXXXXXX RIMM$1.64
XXXXXXXXXX CRM$0.19
GEOXXXXX PAY$0.30
mrbilltraderXXXXX POT$1.59
XXXXXXXXXX OVTI$0.43
sam farahanXXXXX TECD$0.95
XXXXXXXXXX GSS$0.05
XXXXXXXXXX ABB$0.31
adfgafg ERTS$0.48