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02.06.2014 06:26:14

ARIA Making News, IMMU On The Move, SQNM Does A Deal, Threshold Finds MTD

(RTTNews) - ARIAD Pharmaceuticals Inc.'s (ARIA) approved cancer drug Iclusig has demonstrated anti-tumor activity in patients with refractory metastatic and/or unresectable gastrointestinal stromal tumors in a phase II trial.

Iclusig was approved to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases, in December of 2012 under the FDA's accelerated approval program. Last October, the company reported that serious arterial thrombosis, cardiovascular events, cerebrovascular events and peripheral vascular events were observed in Iclusig-treated patients in a pivotal follow up of trial, dubbed PACE.

Due to the adverse events in the PACE trial, the FDA placed a partial clinical hold on all new patient enrollment in clinical trials of Iclusig.

Now, the partial clinical hold has been lifted, and the trial is ongoing.

ARIA closed Friday's trading at $6.46, up 1.25%.

Ignyta Inc. (RXDX) has revealed positive interim data from its phase I trial of RXDX-101, the company's proprietary oral tyrosine kinase inhibitor targeting solid tumor indications, which showed no dose-limiting toxicities and very promising signs of antitumor activity.

RXDX closed Friday's trading at $7.40, up 2.21%.

Immunomedics Inc. (IMMU) has reported encouraging efficacy results from its phase Ib trial of investigational cancer therapeutic Yttrium-90-labeled Clivatuzumab Tetraxetan in patients with metastatic pancreatic cancer.

According to the trial results, there was an overall disease response rate of 41%, including 2 patients (7%) with partial response and 10 patients (34%) with stable disease as best response, in 29 patients with relapsed/refractory, metastatic pancreatic cancer treated with Yttrium-90-labeled Clivatuzumab Tetraxetan, in combination with low-dose gemcitabine as a radiosensitizer.

Based on the encouraging results, the company has launched phase III PANCRIT-1 registration trial, positioning 90Y-clivatuzumab tetraxetan as a therapy for pancreatic cancer patients in late-stage setting. Patient accrual in the trial is expected to be completed by the second half of 2015, with top-line results expected in the first half of 2016.

IMMU closed Friday's trading at $3.33, down 4.03%.

Prima BioMed Ltd.'s (PBMD) lead product candidate CVac, an autologous dendritic cell- based product, has demonstrated a positive trend in overall survival over standard of care in second remission ovarian cancer patients in a phase II trial. The company is scheduled to report the final overall survival data towards the end of this calendar year.

PBMD closed Friday's trading at $1.45, down 2.03%.

Sequenom Inc. (SQNM) has sold its Bioscience business to Agena Bioscience, a portfolio company of Telegraph Hill Partners, for a price of $31.8 million, subject to certain adjustments.

SQNM closed Friday's trading at $3.07.

Threshold Pharmaceuticals Inc.'s (THLD) ongoing phase 1/2 trial of its investigational hypoxia-activated prodrug, TH-302, has revealed that the compound in combination with low-dose dexamethasone in patients with relapsed/refractory multiple myeloma, has a clinical benefit rate of 31% at the maximum-tolerated dose of 340 mg/m2 of TH-302.

THLD closed Friday's trading at $3.86, down 1.53%.

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