Navigation Links
Array BioPharma Provides Clinical Update On ARRY-614 For Myelodysplastic Syndromes At The 2013 American Society Of Hematology Meeting

BOULDER, Colo., Dec. 9, 2013 /PRNewswire/ -- Earlier today, Array BioPharma Inc. (NASDAQ: ARRY) announced updated clinical safety and efficacy data on ARRY‑614 in patients with myelodysplastic syndromes (MDS) at the 2013 Annual Meeting of the American Society of Hematology.


ARRY-614 is a potent inhibitor of p38/Tie2 with a mechanism of action distinct from drugs currently available to treat MDS.  It is being studied in an ongoing dose-escalation trial in IPSS low/intermediate-1 risk MDS patients, representing a population of more than 100,000 patients in developed countries.  The dose-escalation portion of the trial established the maximum tolerated dose, and subsequent expansion cohorts have been fully enrolled.

Of patients currently evaluable for efficacy, 21% achieved a Hematologic Improvement, as defined by International Working Group 2006 (IWG). Of particular interest, 44% of platelet-transfusion dependent patients achieved Transfusion Reduction, and 31% achieved Transfusion Independence. Lower risk MDS patients with severe low platelet counts have a particularly poor prognosis. The most common treatment-related adverse events across all doses were rash (39%), nausea (17%), and atrial fibrillation (13%).  The majority of these events were mild or moderate in severity.

"The emerging results from this study with ARRY-614 are very promising," said Guillermo Garcia-Manero, M.D., Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.  "ARRY-614 was generally well tolerated in these lower-risk MDS patients and I am particularly encouraged with the platelet effects observed in patients with thrombocytopenia, including platelet transfusion independence.  Responses were seen in patients for whom hypomethylating agents had failed, a group with no available treatment options."

"Significant unmet needs remain in the treatment of MDS," said Michael Needle, M.D., Chief Medical Officer, Array BioPharma.  "ARRY-614 is thought to operate at the progenitor cell level, distinct from currently available therapies, offering a unique mechanism of action for treatment of the cytopenias associated with MDS."

A PDF of the slides are available on Array's website at

About ARRY-614 for MDS
ARRY-614 is being studied in low/intermediate-1 risk MDS, a population of more than 100,000 patients in developed countries.  In a previous study, using a different formulation of ARRY-614, multi-lineage activity was observed with the most promising effects seen in patients with thrombocytopenia and neutropenia, with several platelet transfusion-dependent patients becoming transfusion-independent.  Array is evaluating an enhanced formulation of ARRY-614 in the current dose-escalation clinical trial. Pharmacokinetic and pharmacodynamics assays performed as part of the trial have demonstrated improved bioavailability and target coverage relative to the previously-evaluated formulation. Mature data from this trial is expected in 2014.  With these results, Array intends to discuss future development plans with regulatory authorities.  

About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer.  Seven Phase 3 or pivotal studies are already in progress, or are planned to begin, within the next year. These programs include the wholly-owned hematology drug, filanesib (ARRY-520), for multiple myeloma and two partnered cancer drugs, selumetinib (AstraZeneca) and MEK162 (Novartis).  For more information on Array, please go to

Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the timing of the announcement of the results of clinical trials for our proprietary and our partnered programs, the timing of the completion or initiation of further development of our wholly-owned and our partnered programs, the potential for the results of ongoing preclinical and clinical trials to support regulatory approval or the marketing success of a drug candidate, and our future plans to progress and develop our proprietary programs. These statements involve significant risks and uncertainties, including those discussed in our most recent annual report filed on Form 10-K, in our quarterly reports filed on Form 10-Q, and in other reports filed by Array with the Securities and Exchange Commission. Because these statements reflect our current expectations concerning future events, our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors. These factors include, but are not limited to, our ability to continue to fund and successfully progress internal research and development efforts and to create effective, commercially viable drugs; risks associated with our dependence on our collaborators for the clinical development and commercialization of our out-licensed drug candidates; the ability of our collaborators and of Array to meet objectives tied to milestones and royalties; our ability to effectively and timely conduct clinical trials in light of increasing costs and difficulties in locating appropriate trial sites and in enrolling patients who meet the criteria for certain clinical trials; risks associated with our dependence on third-party service providers to successfully conduct clinical trials within and outside the United States; our ability to achieve and maintain profitability and maintain sufficient cash resources; the extent to which the pharmaceutical and biotechnology industries are willing to in-license drug candidates for their product pipelines and to collaborate with and fund third parties on their drug discovery activities; our ability to out-license our proprietary candidates on favorable terms; and our ability to attract and retain experienced scientists and management. We are providing this information as of December 9, 2013. We undertake no duty to update any forward-looking statements to reflect the occurrence of events or circumstances after the date of such statements or of anticipated or unanticipated events that alter any assumptions underlying such statements.


Tricia Haugeto

(303) 386-1193

SOURCE Array BioPharma
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Global Array Instrument Market is Expected to Reach USD 3.2 Billion Globally in 2017: Transparency Market Research
2. Array BioPharma Reports Financial Results For The First Quarter Of Fiscal 2013
3. Array BioPharma To Present Clinical Data On ARRY-797 At The 2012 American College Of Rheumatology Annual Meeting
4. Array BioPharma Announces Proposed Public Offering Of Common Stock
5. Array BioPharma Announces Pricing Of Public Offering Of Common Stock
6. Array BioPharma To Present At The Piper Jaffray Annual Healthcare Conference
7. InternetArray Collaborates with Health Sciences Group to Fund Medical Marijuana Social Media/Mobile Apps Development
8. Array BioPharma To Present At The Leerink Swann Global Healthcare Conference
9. Zacks Bull and Bear of the Day Highlights: Fortune Brands Home & Security, Wal-Mart Stores, Regeneron Pharmaceuticals, Bayer and Array Biopharma
10. Array BioPharma To Present At The Cowen Annual Health Care Conference
11. Array BioPharma Names Michael N. Needle, M.D. As Chief Medical Officer
Post Your Comments:
(Date:6/24/2016)...   Pulmatrix, Inc ., (NASDAQ: PULM ... announced today that it was added to the Russell ... comprehensive set of U.S. and global equity indexes on ... milestone for Pulmatrix," said Chief Executive Officer Robert ... progress in developing drugs for crucial unmet medical needs, ...
(Date:6/23/2016)... Calif. , June 23, 2016 Any dentist ... many challenges of the current process. Many of them do ... of the technical difficulties and high laboratory costs involved. And ... to offer it at such a high cost that the ... it. Dr. Parsa Zadeh , founder of ...
(Date:6/23/2016)... Capricor Therapeutics, Inc. ... company focused on the discovery, development and commercialization ... in its ongoing randomized HOPE-Duchenne clinical trial (Halt ... its 24-patient target. Capricor expects the trial to ... 2016, and to report top line data from ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... closing of Bruton Memorial Library on June 21 due to a possible lice infestation, as ... of head lice: the parasite’s ability to live away from a human host, and to ... one in the event that lice have simply gotten out of control. , As lice ...
(Date:6/25/2016)... , ... June 25, 2016 , ... As a lifelong ... Cum Laude and his M.D from the David Geffen School of Medicine at UCLA. ... to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of ... of the latter, setting the bar too high can result in disappointment, perhaps even ... progress toward their goal. , Research from reveals that behind ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... June 19, ... the dangers associated with chronic pain and the benefits of holistic treatments, Serenity ... who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. ... The attorneys chosen by their peers for this recognition are considered among the top ... Shareholders received special honors as members of this year’s Legal Elite Hall of Fame: ...
Breaking Medicine News(10 mins):