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TOPIC: STAR Trial Reaches Full Enrollment

STAR Trial Reaches Full Enrollment 25 May 2016 07:32 #7100

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All the good news is now in place for the execution of the rights offering....


SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc.(CYTX) today announced that its U.S. FDA-approved phase III STAR trial has enrolled its 80th patient (100% of target enrollment). All 80 patients enrolled thus far in both trial arms have been successfully treated without complications. Full trial data are expected to be available in mid-2017.

“The collaboration of our industry, health care professions, health care institutions, and patients has led to our ability to fully enroll the STAR trial ahead of schedule. We are now one step closer to having Cytori Cell Therapy available to patients suffering from hand problems due to scleroderma. It is critical that we remain focused on careful and accurate data collection through the follow-up period. Even though the patients, the investigators, and Cytori remain blinded, we can say that the procedures are feasible and were well-tolerated by the STAR patients,” said Dr. Steven Kesten, Chief Medical Officer, Cytori Therapeutics(CYTX).

Strong interest and rapid screening across the multiple trial sites in particular during the peak enrollment period of the last two months will result in additional patients being enrolled into the trial. As a result, final enrollment will exceed the original target of 80 patients. All additional patients have been scheduled such that the final procedure day will occur in early June.

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 have been randomized, with approximately 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. Details of the STAR trial, including inclusion and exclusion criteria, can be found at the following link: clinicaltrials.gov.

The STAR trial follows the French 12-patient, investigator-initiated, open-label SCLERADEC-I pilot trial, which was performed at the Assistance Publique Hôpitaux de Marseille. One year post-treatment results were published in the August 2015 edition of the journal Rheumatology. Data recently presented at the Systemic Sclerosis World Congress indicated that a single administration of ECCS-50 therapy was well-tolerated and that treated patients exhibited significant improvements in hand symptoms, function, and Raynaud’s Phenomena through 2 years following treatment.

Cytori announced in January 2016 that it entered into an agreement with Idis to establish a Managed Access Program (MAP) for its cellular therapeutic in select countries across Europe, the Middle East, and Africa for patients with impaired hand function due to scleroderma. Managed Access Programs provide biopharmaceutical companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available. The source of medicine funding varies and may include the hospital’s budget or country’s sickness fund or social security system.
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STAR Trial Reaches Full Enrollment 07 Jun 2016 06:10 #7176

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Cytori Announces Enrollment Completion in U.S. Phase III Scleroderma Trial




Jun 07, 2016




SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced completion of enrollment for its U.S. FDA approved Phase III STAR trial. A total of 88 patients were enrolled ahead of schedule, and all procedures were completed successfully without complications.

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.

Approximately equal number of patients have received Cytori Cell Therapy and 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. Based on enrollment, data should be available mid-2017. Details of the STAR trial including inclusion and exclusion criteria can be found at the following link: clinicaltrials.gov

About Cytori
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information visit www.cytori.com .

Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, without limitation, conduct of Cytori’s STAR trial (including timely completion of, and availability of data from, the STAR clinical), are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, inherent risk and uncertainty in the protection intellectual property rights, regulatory uncertainties, risks in the conduct of clinical trials, risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, performance and acceptance of our products in the marketplace, as well as other risks and uncertainties described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.





View source version on businesswire.com: www.businesswire.com/news/home/20160607005716/en/

Source: Cytori Therapeutics, Inc.


Cytori Therapeutics, Inc.

Tiago Girao, 1-858-458-0900

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STAR Trial Reaches Full Enrollment 08 Jun 2016 05:31 #7183

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This is incredibly sad. Cytori is in a phase 3 for what seems like a win/win for their technology and STILL CANNOT SECURE A PARTNER / BUYOUT.

This is a RED FLAG. Phase 1 bios are being purchased for $5B and we can't even secure a measly $100m partner?

The greed/ short-sightedness of Hedrick and Rickey is what is sabotaging these deals (if any deals are even being presented). The street knows and me thinks our BOD is alienating themselves from affable suitors
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STAR Trial Reaches Full Enrollment 08 Jun 2016 12:22 #7190

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It will be interesting to see the level of participation by each officer of the company and each board member. 100% participation could be very misleading as it only takes $2.55 to join the club.

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STAR Trial Reaches Full Enrollment 27 Jun 2016 12:20 #7331

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Amazing, How much did Maxim earn from the recent Rights offering?

One would think they knew that the STAR trial is fully enrolled, out this morning..................


"STAR is a randomized, placebo-controlled, double-blind, parallel group pivotal
study investigating the efficacy and safety of Cytori's autologous (adipose derived)
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 ECCS-50 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 later in 2016."

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