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LONDON, UK / ACCESSWIRE / November 14, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Blueprint Medicines Corp. (NASDAQ: BPMC), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/'symbol=BPMC. The Company announced on November 10, 2017, new data from the ongoing Phase-1 clinical trial of BLU-285, as a potential treatment for patients with advanced gastrointestinal stromal tumors (GIST). For immediate access to our complimentary reports, including today's coverage, register for free now at:
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Based on the strength of the data in patients with KIT-driven GIST, the Company also announced an expansion of the ongoing Phase-1 trial. Blueprint Medicines has recently increased the enrollment target for patients previously treated with imatinib and at least one additional tyrosine kinase inhibitor (TKI) from 50 to 100 patients, and has also added a new cohort to evaluate BLU-285 in second-line GIST.
Phase-1 Clinical Trial for BLU-285 in PDGFRa-Driven and KIT-Driven GIST
The Phase-1 clinical trial of BLU-285 is designed to evaluate the safety and tolerability of BLU-285 in adults with advanced GIST. The trial consists of two parts: (i) a dose-escalation portion, which is complete, and (ii) an expansion portion. The expansion portion is actively enrolling patients in three defined cohorts consisting of a cohort of patients with a PDGFRa D842V mutation, regardless of line of therapy; a cohort of patients who have received imatinib and at least one other KIT-directed TKI; and a cohort of patients who have received imatinib and no other TKI. All response assessments use blinded, central radiology review. The three expansion cohorts of the trial are designed to enroll a total of 200 patients at multiple sites in the United States, the United Kingdom, and the European Union.
New Data from the Ongoing Phase-1 Clinical Trial
As of October 11, 2017, 116 patients had been treated with BLU-285 in the dose escalation and expansion portions of the Phase-1 clinical trial at eight dose levels, including 76 patients with KIT-driven GIST; 39 patients with PDGFRa-driven GIST; and one patient with KIT/PDGFRa wild-type GIST. The Company selected 300 mg daily dose (QD) as the recommended part 2 dose (RP2D) for the expansion portion of the clinical trial.
BLU-285 was generally well-tolerated. Most common treatment-emergent adverse effects reported by investigators included nausea, fatigue, periorbital edema, vomiting, edema peripheral, anemia, diarrhea, increased lacrimation, cognitive effects, amongst others. Among all the 116 enrolled patients, 67 remained on treatment as of the data cutoff date. 30 patients with KIT-driven GIST treated at 300 mg to 400 mg QD, and 31 patients with PDGFRa D842-driven GIST treated at all doses, were evaluable for response assessments. Centrally assessed radiographic tumor reductions were observed in 20 of 30 evaluable patients across all common KIT genotypes, and in all 31 evaluable patients with PDGFRa-driven GIST.
Blueprint Medicines Looks Forward to Work with FDA Under Breakthrough Therapy Designation Program
Andy Boral, M.D., Chief Medical Officer of Blueprint Medicines, stated that the Company continues to plan for expedited development of BLU-285 in patients with PDGFRa D842V-driven GIST, and is looking forward to working with the US Food and Drug Administration (FDA) under the Breakthrough Therapy Designation program to determine the fastest path forward for BLU-285 in this population. In addition, the objective responses and prolonged progression free survival seen in patients with heavily pretreated KIT-driven GIST gives the Company increased confidence in its approach to expand development of BLU-285 in third- and second-line treatment.
Blueprint Medicines Plans to Pursue Expedited Development of BLU-285
As announced on June 05, 2017, the Company plans to pursue expedited development of BLU-285 in patients with PDGFRa D842V-driven GIST. It is on track to initiate a global, randomized Phase-3 clinical trial of BLU-285 in third-line GIST in the first half of 2018, with the goal of supporting registration of BLU-285 in a broader GIST patient population.
About Gastrointestinal Stromal Tumors (GIST)
GIST is the most common sarcoma, or tumor of bone, in which abnormal cells form in the tissues of the gastrointestinal tract. Signs of gastrointestinal stromal tumors include blood in the stool or vomit, and most patients are diagnosed between the ages of 50-80. Genetic factors can increase the risk of having a GIST, and may be malignant (cancer) or benign (not cancer).
About BLU-285
BLU-285 is an oral, investigational drug that inhibits PDGFRa D842V and KIT Exon 17 mutants, which play a key role in GIST. Pre-clinical data have shown that BLU-285 is active across a broad spectrum of KIT and PDGFRa mutations, including PDGFRa D842V and KIT exon 17 mutations for which there are limited or no effective treatment options. Blueprint Medicines is initially developing BLU-285, an investigational medicine, for the treatment of patients with advanced GIST and advanced systemic mastocytosis.
About Blueprint Medicines Corp.
Established in 2011, Blueprint Medicines is a biopharmaceutical Company developing a new generation of highly selective and potent kinase therapies to dramatically improve the lives of patients with genomically defined diseases. The Company is headquartered in Cambridge, Massachusetts.
Last Close Stock Review
On Monday, November 13, 2017, the stock closed the trading session at $69.05, rising 1.07% from its previous closing price of $68.32. A total volume of 287.69 thousand shares have exchanged hands. Blueprint Medicines' stock price soared 50.14% in the last three months, 67.11% in the past six months, and 98.59% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have skyrocketed 146.17%. At Monday's closing price, the stock's net capitalization stands at $2.78 billion.
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