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CAMBRIDGE, Mass. & LONDON–(BUSINESS WIRE)–ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) and Newcastle University, U.K., on account of the U.K. National Blight Analysis Institute (NCRI) CML Working Group, today appear an acceding to coact on a multicenter, randomized Appearance 3 trial, called SPIRIT 3, to appraise the appulse of switching patients with abiding myeloid leukemia (CML) actuality advised with a first-line tyrosine kinase inhibitor, aloft suboptimal acknowledgment or analysis failure, to ponatinib. The NCRI expects to activate acceptance in the balloon of 1,000 patients at about 172 analytic analysis sites in the U.K. in the added division of 2013.
“The SPIRIT 3 abstraction was advised in affiliation with ARIAD to accommodate the accurate association and patients active with chronic-phase CML a added compassionate of the best able means to use TKIs and whether we can advance analysis outcomes by switching patients to ponatinib, who accept bootless to accomplish optimal acknowledgment from imatinib or nilotinib,” declared Stephen G. O’Brien, Professor of Haematology at the Northern Institute for Blight Analysis at Newcastle University, NCRI affiliate and arch investigator of the SPIRIT 3 study. “We attending advanced to assessing ponatinib as a analysis in this ambience and evaluating its abeyant clinical, bread-and-butter and quality-of-life benefits.”
Balloon Architecture and Statistical Analysis
The SPIRIT 3 balloon is a randomized, two-arm, multicenter balloon that compares above atomic acknowledgment (MMR) at three years in anew diagnosed patients advised with imatinib to those advised with nilotinib, aback patients are “rescued” with ponatinib aloft suboptimal acknowledgment at three or 12 months or analysis failure. The SPIRIT 3 balloon will accept developed patients with chronic-phase CML diagnosed aural three months and ahead basic for CML with any TKI therapy. About 1,000 patients will be randomized 1:1 to accepted doses of imatinib (400 mg orally already daily) or nilotinib (300 mg orally alert daily). Patients will be switched to ponatinib (45 mg orally already daily) based on authentic belief of suboptimal response, analysis failure, or bent to first-line therapy.
The primary endpoint of the abstraction is the admeasurement of patients who accept accomplished MMR at three years on their initially allocated aboriginal band of therapy, behindhand of about-face to ponatinib. MMR is authentic as a beneath than or according to 0.1% arrangement of BCR-ABL to ABL transcripts on the International Scale abstinent in borderline claret by PCR testing.
The sample admeasurement of 500 patients per arm in the SPIRIT 3 agreement provides over 90 percent ability to appearance noninferiority in three-year MMR ante amid patients starting on imatinib, acceptance about-face to ponatinib, and patients starting on nilotinib, acceptance about-face to ponatinib. These sample admeasurement calculations use a noninferiority allowance of a 10 percent complete aberration and accept a 73 percent MMR amount at three years in anniversary arm.
Secondary endpoints accommodate the admeasurement of patients who accept accomplished analysis abeyance three years from accepting accomplished abiding MMR, amount of analysis (measured as incremental amount per affection adapted action year gained), all-embracing survival, progression-free survival, event-free survival, and analysis abortion ante at bristles years, as able-bodied as assurance and tolerability of the TKIs. Anniversary accommodating will be followed for a minimum of bristles years from the time the aftermost accommodating in the balloon is randomized to either analysis arm.
A key affection of the balloon is that patients accomplishing abiding MMR will be offered the befalling to abate the dosage of their TKI analysis or stop analysis altogether. These patients will be monitored added carefully with account PCR testing and will be changed aback to full-dose TKI analysis for accident of MMR at any time or ascent BCR-ABL archetype arrangement on two afterwards tests.
“We are acutely committed to allowance physicians and CML patients advance outcomes with TKI therapy,” declared Frank G. Haluska, M.D., Ph.D., arch medical administrator at ARIAD. “The SPIRIT 3 balloon will appraise the abeyant for ponatinib to advance outcomes in patients who accept sub-optimal responses aboriginal in the advance of first-line analysis for CML, by enabling those patients with a poorer cast to about-face TKI therapy. This should accept important implications for the approaching administration of CML.”
About Iclusig™ (ponatinib)
Iclusig is a kinase inhibitor. The primary ambition for Iclusig is BCR-ABL, an aberrant tyrosine kinase that is bidding in abiding myeloid leukemia (CML) and Philadelphia-chromosome absolute astute lymphoblastic leukemia (Ph ALL). Iclusig was advised application ARIAD’s computational and structure-based biologic architecture belvedere accurately to arrest the action of BCR-ABL. Iclusig targets not alone built-in BCR-ABL but additionally its isoforms that backpack mutations that advise attrition to treatment, including the T315I mutation, which is the best accepted alteration amid advancing patients. Iclusig is the alone TKI that is able in CML and Ph ALL patients with this mutation.
Please see the abounding prescribing information, including the Boxed Warning, for Iclusig at www.ariad.com or www.iclusig.com.
Indication, Usage and Dosing
Iclusig is adumbrated for the analysis of developed patients with abiding phase, accelerated phase, or bang appearance abiding myeloid leukemia (CML) that is advancing or antipathetic to above-mentioned tyrosine kinase inhibitor (TKI) analysis or Philadelphia chromosome-positive astute lymphoblastic leukemia (Ph ALL) that is advancing or antipathetic to above-mentioned TKI therapy.
This adumbration is based aloft acknowledgment rate. There are no trials acceptance an advance in disease-related affection or added adaptation with Iclusig.
The recommended dosage of Iclusig is a 45 mg book taken once-daily with or afterwards food.
Important Assurance Advice
Cardiovascular, cerebrovascular, and borderline vascular thrombosis, including baleful myocardial infarction and achievement accept occurred in Iclusig-treated patients. Austere arterial occlusion occurred in 8% of Iclusig-treated patients. Arrest and accede cessation of Iclusig in patients who advance arterial thrombotic events.
Hepatotoxicity, alarmist abortion and afterlife accept occurred in Iclusig-treated patients. Monitor hepatic action above-mentioned to and during treatment. Arrest and again abate or abandon Iclusig for hepatotoxicity.
Warnings and Precautions
Twenty patients advised with Iclusig (4%) accomplished austere congestive affection abortion (CHF) or larboard ventricular dysfunction, with 4 fatalities. Monitor patients for signs or affection constant with CHF and amusement as clinically indicated, including abeyance of Iclusig. Accede cessation of Iclusig in patients who advance austere CHF.
Eight patients advised with Iclusig (2%) accomplished treatment-emergent appropriate hypertension as a austere adverse reaction, including hypertensive crisis. Treatment-emergent hypertension occurred in 67% of patients. Monitor and administer claret burden elevations.
Analytic pancreatitis occurred in 6% of patients (5% Brand 3) advised with Iclusig. The accident of analysis appearing lipase acclivity was 41%. Check serum lipase every 2 weeks for the aboriginal 2 months and again account thereafter or as clinically indicated. Dosage abeyance or abridgement may be required. In cases area lipase elevations are accompanied by belly symptoms, arrest analysis with Iclusig and appraise patients for pancreatitis.
Austere bleeding contest occurred in 5% of patients advised with Iclusig, including fatalities. The accident was college in patients with AP-CML, BP-CML, and Ph ALL. Best contest occurred in patients with brand 4 thrombocytopenia. Arrest Iclusig for austere or astringent hemorrhage.
Austere aqueous assimilation contest occurred in 3% of patients advised with Iclusig. One instance of academician edema was fatal. Monitor patients for aqueous assimilation and administer patients as clinically indicated. Interrupt, reduce, or abandon Iclusig as clinically indicated.
Appropriate bradyarrhythmias that led to a claim for pacemaker article occurred in 3 (1%) Iclusig-treated patients. Advise patients to address signs and affection evocative of apathetic affection amount (fainting, dizziness, or chest pain).
Supraventricular tachyarrhythmias occurred in 5% of Iclusig-treated patients. Atrial fibrillation was the best accepted supraventricular tachyarrhythmia. Advise patients to address signs and affection of accelerated affection amount (palpitations, dizziness).
Astringent (Grade 3 or 4) myelosuppression occurred in 48% of patients advised with Iclusig.
Obtain complete claret counts every 2 weeks for the aboriginal 3 months and again account or as clinically indicated, and acclimatize the dosage as recommended.
Two patients (<1%) advised with Iclusig developed austere bump lysis syndrome. Hyperuricemia occurred in 7% of patients. Ensure able hydration and amusement aerial uric acerbic levels above-mentioned to initiating analysis with Iclusig.
Since Iclusig may accommodation anguish healing, arrest Iclusig for at atomic 1 anniversary above-mentioned to above surgery. Austere gastrointestinal breach (fistula) occurred in one accommodating 38 canicule post-cholecystectomy.
Iclusig can account fetal harm. Advise women to abstain abundance while demography Iclusig.
The best accepted non-hematologic adverse reactions (≥20%) were hypertension, rash, belly pain, fatigue, headache, dry skin, constipation, arthralgia, nausea, and pyrexia. Hematologic adverse reactions included thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia. Please see the abounding Prescribing Advice for Iclusig, including the Boxed Warning.
About CML and Ph ALL
CML is characterized by an boundless and able assembly of white claret beef by the cartilage bottom due to a abiogenetic aberancy that produces the BCR-ABL protein. Afterwards a abiding appearance of assembly of too abounding white claret cells, CML about evolves to the added advancing phases referred to as accelerated appearance and bang crisis. Ph ALL is a subtype of astute lymphoblastic leukemia that carries the Ph chromosome that produces BCR-ABL. It has a added advancing advance than CML and is generally advised with a aggregate of chemotherapy and tyrosine kinase inhibitors. The BCR-ABL protein is bidding in both of these diseases.
About the NCRI
The U.K. National Blight Analysis Institute (NCRI) was accustomed in April 2001. It is a U.K-wide affiliation amid the government, alms and industry which promotes co-operation in blight analysis amid the twenty-two affiliate organisations for the account of patients, the accessible and the accurate community. For added advice appointment www.ncri.org.uk
NCRI associates are: the Association of the British Pharmaceutical Industry (ABPI); Association for International Blight Research; Biotechnology and Biological Sciences Analysis Council; Breakthrough Breast Cancer; Breast Blight Campaign; Blight Analysis UK; CHILDREN with CANCER UK; Department of Health; Bread-and-butter and Social Analysis Council; Leukaemia & Lymphoma Research; Ludwig Institute for Blight Research; Macmillan Blight Support; Marie Curie Blight Care; Medical Analysis Council; Northern Ireland Health and Social Care (Research & Development Office); Prostate Blight UK; Roy Castle Lung Blight Foundation; Scottish Government Health Directorates (Chief Scientist Office); Tenovus; The Wellcome Trust; Welsh Government (National Institute for Social Care and Health Research); and Yorkshire Blight Research.
ARIAD Pharmaceuticals, Inc. is a all-around oncology aggregation focused on the discovery, development and commercialization of medicines to transform the lives of blight patients. ARIAD’s aboriginal medicine, Iclusig™, is accustomed in the U.S. for the analysis of developed patients with chronic, accelerated or bang appearance abiding myeloid leukemia that is advancing or antipathetic to above-mentioned tyrosine kinase inhibitor (TKI) analysis or Philadelphia chromosome-positive astute lymphoblastic leukemia that is advancing or antipathetic to above-mentioned TKI therapy. Added analytic trials of Iclusig in added cancers are ongoing. ARIAD is additionally belief AP26113, addition molecularly targeted medicine, in assertive forms of lung cancer. For added information, appointment http://www.ariad.com or chase ARIAD on Twitter (@ARIADPharm).
This columnist absolution contains “forward-looking statements” including, but not bound to, abeyant authoritative approvals, new break or labeling for, or abeyant approaching sales of Iclusig. Advanced statements are based on management’s expectations and are accountable to assertive factors, risks and uncertainties that may account absolute results, aftereffect of events, timing and achievement to alter materially from those bidding or adumbrated by such statements. These risks and uncertainties include, but are not bound to, preclinical abstracts and early-stage analytic abstracts that may not be replicated in later-stage analytic studies, the costs associated with our research, development, accomplishment and added activities, the conduct, timing and after-effects of pre-clinical and analytic studies of our artefact candidates, the capability of our basic assets and the availability of added funding, and added factors abundant in the Company’s accessible filings with the U.S. Securities and Exchange Commission. The advice independent in this columnist absolution is believed to be accepted as of the date of aboriginal issue. The Aggregation does not intend to amend any of the advanced statements afterwards the date of this certificate to accommodate these statements to absolute after-effects or to changes in the Company’s expectations, except as appropriate by law.
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