CAMBRIDGE, Mass., March 28,
2023 /PRNewswire/ -- Blueprint Medicines Corporation
(NASDAQ: BPMC) today announced that the U.S. Food and Drug
Administration (FDA) has lifted a partial clinical hold on the
Phase 1/2 VELA trial of BLU-222.
On February 10, 2023, Blueprint
Medicines announced the FDA placed a partial clinical hold on the
VELA trial due to reported visual adverse events, consisting of
transient, reversible episodes of light sensitivity and blurred
vision, observed in a limited number of patients. Patients already
enrolled in the trial have continued receiving study drug. The
partial clinical hold is lifted as of March
28, and Blueprint Medicines is working with trial sites to
reinitiate patient enrollment.
"With a focus on patient safety, we have worked diligently with
the FDA over the last several weeks to resolve the partial clinical
hold by updating adverse event monitoring and management
procedures. We will now collaborate closely with investigators to
resume patient enrollment," said Becker Hewes, M.D., Chief Medical
Officer at Blueprint Medicines. "We are confident in the potential
of BLU-222 to improve outcomes in patients with cancers vulnerable
to CDK2 inhibition, and we look forward to presenting initial dose
escalation data from the VELA trial in the second quarter of
2023."
About Blueprint Medicines
Blueprint Medicines is a global precision therapy company
that invents life-changing therapies for people with cancer and
blood disorders. Applying an approach that is both precise and
agile, we create medicines that selectively target genetic drivers,
with the goal of staying one step ahead across stages of disease.
Since 2011, we have leveraged our research platform, including
expertise in molecular targeting and world-class drug design
capabilities, to rapidly and reproducibly translate science into a
broad pipeline of precision therapies. Today, we are delivering our
approved medicines to patients in the United
States and Europe, and we are globally advancing multiple
programs for systemic mastocytosis, lung cancer, breast cancer and
other genomically defined cancers, and cancer immunotherapy. For
more information, visit www.BlueprintMedicines.com and
follow us on Twitter (@BlueprintMeds) and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding the continuation of participants in Blueprint Medicines'
VELA trial, Blueprint Medicines' ability to resume enrollment in
the VELA trial, Blueprint Medicines' expectations regarding the
benefit-risk profile of BLU-222, the potential of Blueprint
Medicines' current or future drug candidates in treating patients
with cancers vulnerable to CDK2 inhibition, and the anticipated
timing of initial clinical data from the VELA trial. The words
"aim," "may," "will," "could," "would," "should," "expect," "plan,"
"anticipate," "intend," "believe," "estimate," "predict,"
"project," "potential," "continue," "target" and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management's current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation: the risk that the partial clinical hold may or may not
impact the timing of presentation of initial dose escalation data;
the amendments to the trial protocol may impact the timing of the
trial or evaluation of the data; preliminary activity and safety
data may not be representative of more mature data; the ongoing
COVID-19 pandemic may impact Blueprint Medicines' business,
operations, strategy, goals and anticipated milestones, including
ongoing and planned research and discovery activities, Blueprint
Medicines' ability to conduct ongoing and planned clinical trials,
or the supply of its current or future drug candidates; the risk of
delay of any current or planned clinical trials or the development
of our current or future drug candidates; risks related to
Blueprint Medicines' ability to successfully demonstrate the safety
and efficacy of Blueprint Medicines' drug candidates and gain
approval of its drug candidates on a timely basis, if at all;
preclinical and clinical results for Blueprint Medicines' drug
candidates may not support further development of such drug
candidates either as monotherapies or in combination with other
agents or may impact the anticipated timing of data or regulatory
submissions; the timing of the initiation of clinical trials and
trial cohorts at clinical trial sites and patient enrollment rates
may be delayed or slower than anticipated; actions of regulatory
agencies may affect the initiation, timing and progress of clinical
trials; risks related to Blueprint Medicines' ability to obtain,
maintain and enforce patent and other intellectual property
protection for its products and current or future drug candidates;
and the success of Blueprint Medicines' current and future
collaborations, financing arrangements, partnerships or licensing
arrangements. These and other risks and uncertainties are described
in greater detail in the section entitled "Risk Factors" in
Blueprint Medicines' filings with the Securities and Exchange
Commission (SEC), including Blueprint Medicines' most recent Annual
Report on Form 10-K, as supplemented by its most recent Quarterly
Report on Form 10-Q and any other filings that Blueprint Medicines
has made or may make with the SEC in the future. Any
forward-looking statements contained in this press release
represent Blueprint Medicines' views only as of the date hereof and
should not be relied upon as representing its views as of any
subsequent date. Except as required by law, Blueprint Medicines
explicitly disclaims any obligation to update any forward-looking
statements.
Trademarks
Blueprint Medicines and associated logos are trademarks of
Blueprint Medicines Corporation.
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SOURCE Blueprint Medicines Corporation