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August 12, 2014
11:20 EDTCYTXCytori Therapeutics reports publication of six month data from scleroderma study
Cytori Therapeutics (NASDAQ: CYTX) today announced that six month outcomes from a 12 patient independent investigator-initiated study using Cytori Cell Therapy to treat scleroderma have been published in the Annals of Rheumatic Disease. Data from the study indicated that treatment with Cytori Cell Therapy was safe and well tolerated through six months. In addition, the data indicated an approximately 50% average improvement across four key, validated endpoints used to assess the clinical status in patients with systemic scleroderma with impaired hand function at two months, with benefits sustained through six month follow-up. “After six month follow up, we are encouraged by the results that have been seen by the investigators in France...The investigators in Marseille have continued to follow the patients and are considering a larger, controlled study based on these positive outcomes,” said Dr. Steven Kesten, Chief Medical Officer, Cytori.
News For 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.
February 3, 2016
07:15 EDTCYTXCytori says Cytori Cell Therapy 'safe' and 'effective' in EU Phase 1 ED trial
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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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