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News For ADBE;ALXA;BBY;BV;ZQK;CYTX From The Last 14 Days
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February 8, 2016
07:01 EDTCYTXCytori Therapeutics reports interim data on U.S. Phase II osteoarthritis trial
Cytori Therapeutics announced the top-line data as part of the pre-specified partial unblinding of 24 week follow up data from the company's ACT-OA trial. The trial is a U.S. phase II randomized, double-blind, placebo controlled trial designed to evaluate the safety and feasibility at 48 weeks of a single intra-articular knee injection of the ECCO-50 cellular therapeutic in patients with chronic knee pain due to osteoarthritis. "Key endpoints and trends observed thus far suggest that a beneficial effect may be attributable to a single intra-articular administration of ECCO-50 in patients with osteoarthritis of the knee," said Dr. Marc H. Hedrick, President and CEO. "The full 48 week data set is the next important milestone in this program. While we continue to move our clinical pipeline along, the company will remain intensely focused on bringing to market our lead therapeutic for scleroderma which is currently in phase III." The primary goal of the ACT-OA trial is to help determine: (1) safety and feasibility of ECCO-50 for osteoarthritis, (2) provide dosing guidance and (3) explore key trial endpoints useful for a phase III trial. As a proof of concept trial, ACT-OA was not sized or powered for statistical significance in any of the endpoints. The purpose of the interim 24 week partial unblinding in this trial is to provide early data that will facilitate key regulatory and business development discussions and provide better understanding of the therapeutic mechanism of action that may impact other clinical programs. The interim analysis pre-specifies the evaluation of a number of patient reported outcomes important in patients with osteoarthritis of the knee. A total of 94 patients were treated in the trial, 31 received a high dose of ECCO-50. Patients, providers and Cytori personnel remain blinded to individual patient treatment allocation and patient subgroup outcomes.
05:27 EDTADBEStocks with implied volatility movement; ADBE SBUX
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February 5, 2016
12:26 EDTADBEOptions with increasing implied volatility
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February 3, 2016
07:15 EDTCYTXCytori says Cytori Cell Therapy 'safe' and 'effective' in EU Phase 1 ED trial
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January 26, 2016
12:12 EDTBBYJP Morgan reports 8.1% passive stake in Best Buy
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January 25, 2016
07:02 EDTCYTXCytori Therapeutics says Phase 3 STAR trial treats 20th patient
Cytori Therapeutics announced that its U.S. FDA approved Phase 3 STAR trial has enrolled and treated its 20th patient -- 25% of target enrollment. In addition, as per the trial protocol, an independent data monitoring committee has reviewed safety data from the initial 10 patients and recommended that the study continue as planned. The 20 procedures, including the fat harvest from small volume liposuction and the finger injections have all been completed successfully and well tolerated. STAR is a randomized, placebo-controlled, double-blind, parallel group phase III FDA approved pivotal study investigating the efficacy and safety of Cytori Cell Therapy (ECCS-50) injected subcutaneously into the fingers of patients with impaired hand function from scleroderma. A total of 80 patients will be randomized with 40 receiving Cytori Cell Therapy and 40 receiving placebo. The double-blind period extends to 48 weeks. After all patients have completed 48 weeks follow-up, the placebo patients will be offered active treatment should they desire treatment and continue to qualify. The trial began enrollment in August 2015 with enrollment expected to be completed by mid-2016. The STAR trial follows the twelve patient SCLERADEC-I pilot trial in which one year post-treatment results were published in the August 2015 edition of the journal Rheumatology. The data indicated that a single administration of ECCS-50 was safe and that treated patients exhibited significant improvements in hand symptoms, function and Raynaud's Phenomena through one-year post-treatment.

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