Since cytori technology prepares adrcs exclusively from an adult human patients own adipose. Cytori therapeutics said that its objective of the athena program was the assessment of safety and feasibility of cytori cell therapy with the support of the celution system automated onsite. The investigators of athena a placebocontrolled, doubleblind, parallel arm trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular hospitalization or death. Florida hospital pepin heart institute is first in west. The twin trials are each testing cytoris adiposederived regenerative. We like this model, as the lipoaspirate would otherwise be disposed. Ascendiant capital lowered its buy rating to hold on cytori therapeutics nasdaq. The objective of the study was to describe baseline data from addressing the need for advanced hpv diagnostics, a prospective, multicenter us cervical cancer screening trial. Cytori therapeutics cytx ecco50 miss main goal in phase 2. The landmark athena clinical study helped shape our understanding of the role of highrisk hpv testing in cervical cancer screening. Regeneron, cytori, and endo health are wellpoised to open higher today.
To assess safety and feasibility of autologous adiposederived regenerative cells adrcs, for treatment of chronic ischemic cardiomyopathy patients. A study in ovarian cancer patients evaluating rucaparib and nivolumab as maintenance treatment following response to frontline platinumbased chemotherapy athena the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Intravenous angiotensin ii for the treatment of highoutput. Safety, tolerability and potential efficacy of injection of autologous adiposederived stromal vascular fraction in the fingers of patients with systemic sclerosis. Phase iii scleroderma trial read this article along with other careers information, tips and advice on biospace. Special situations will reward long term investors fellow investor, quities have bounced back nicely from the selloff in january that began 2015. Cytori looks excellent on the surface including a stunning website. Physicians and scientists have demonstrated the frequency of stem cells in adipose fat tissue to be 2,500 times greater than the frequency of similar cells in bone marrow. Athena trial schema bevacizumab is allowed during the chemotherapy phase, but not during maintenance, ie, during treatment in this study.
Cytori sold only 7 revenue generating systems in the third quarter, bringing the total installed base to 176 units in approximately 30 countries worldwide. Cytori publishes athena trial data for chronic ischemic cardiovascular disease. Safety and feasibility trial of adiposederived regenerative. Cytori athena trial results support symptomatic benefit.
Athena and athena ii trials for cardiovascular indications as well as the need to raise cash to fund. In addition, in january 2018, we announced the investigatorinitiated and cytori supported scleradecii clinical trial in france using habeo cell therapy completed its enrollment and six month. Cytori provides update on athena trial status fiercebiotech. Cytori therapeutics has placed enrolment in the athena and athena ii trials on clinical hold and therefore anticipates that it will not be possible to complete enrolment of the athena i trial prior to the end of 2014 as previously anticipated. Cytx today announced that the results from the athena trials have been published and are now available online in c cytori athena trial. Nov 19, 20 cytori therapeutics page 2 of 36 yale jen, ph.
A trial with dronedarone to prevent hospitalization or death. Welcome to the cytori therapeutics fourth quarter and 2015 earnings results call. Cytori is conducting a phase ii athena study with a second trial athena ii to come in cmi patients. San diego, jun 28, 2016 business wire cytori therapeutics, inc. Athena is a multicenter, prospective, randomized, doubleblind safety and feasibility trial to investigate the use of cytori cell therapy in patients with heart failure due to ischemic heart disease. Athena a placebocontrolled, doubleblind, parallel arm trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular hospitalization or death from any cause in. Cytori publishes athena trial data for chronic ischemic. Intravenous angiotensin ii for the treatment of highoutput shock athos trial. As previously disclosed in the current report on form 8k filed on march 4, 2015, cytori therapeutics, inc. In terms of developing stromal vascular fraction as a product, cytori began two phase ii u. The athena and athena ii trials are each designed to have 45 total. Preclinical and early clinical trials suggest adrcs have excellent potential for ischemic conditions. Safety and feasibility trial of adiposederived regenerative cells.
Stevenkesten is an employee of cytori therapeutics as chief medical. The systemic form, systemic sclerosis, is the focus of the star trial and has a prevalence of 60,000 70,000 patients. San diego, aug 05, 2014 business wire cytori therapeutics cytx has placed enrollment in the athena and athena ii trials on clinical hold and therefore anticipates that it. Positive results would be major catalysts for cytx share value appreciation. May 31, 2016 cytori therapeutics recently announced that its fdaapproved phase 3 star clinical trial evaluating eccs50 has enrolled and treated its 80th patient, reaching 100 percent of its target enrollment. Performance of helix transendocardial biotherapeutic delivery. The scleradecii which is a 40 patient investigator initiated phase 3 trial, very similar in design to star is also enrolling and continues to enroll in europe. There is a need for understanding the overall mace rate associated with different delivery platforms currently in use.
Rationale and design of the athena hf trial aldosterone targeted neurohormonal combined with natriuresis therapy in heart failure javed butler, md, mph, mba,a adrian f. Cytori discuss importance of star trial for scleroderma. Ascendiant downgrades cytori therapeutics as athena trials. To assess the safety and efficacy of adiposederived regenerative cells adrcs delivered via an intramyocardial route in the treatment of chronic ischemic heart disease in patients who are not eligible for percutaneous or surgical revascularization. Cytx announced today the presentation of six and twelve month data from the athena trials at the annual meeting of the society for. The trial will enroll up to 45 patients with nooption cmi who have limited therapeutic options. Emerson perin, md, phd, director, clinical research for cardiovascular medicine and medical director stem cell center, texas heart institute shares an update on the cytori precise trial the. Cytori athena trial for chronic ischemic cardiovascular disease. Pharmaceuticals and medical devices agency pmda and successful submission of the clinical trial notification to the ministry of health, labour and welfare mhlw in japan, in collaboration with cytori therapeutics, k.
Cytx announced the topline data as part of the prespecified partial unblinding of 24 week follow up data from the companys actoa trial. Sep 26, 2016 cytori partner kerastem completes enrollment of u. Cytx announced today the presentation of six and twelve month data from the athena trials at the annual meeting of the society for cardiovascular angiography and. The athena i and ii trials, investigating cytori cell use in patients with ischemic heart failure demonstrated feasibility and safety, but resulted in no differences in lvef or volume when. Cytori athena trial results support symptomatic benefit from cytori cell therapy may 06, 2016 08. If you would like to ask a question at that time, please press 1 on. The landmark athena clinical trial explained in infographics. Yields of melon varieties in the 2017 variety trial in southwest indiana. Reasons i abandoned my long position in cytori nasdaq. Stevenkesten is an employee of cytori therapeutics as chief medical officer.
Aug 06, 2014 cytori provides update on athena trial status. The trial, sponsored by san diegobased cytori therapeutics, derives stem cells from the patients own fat tissue and injects extracted cells into damaged parts of the heart. Eccs50 cytori stem cell therapy nihr innovation observatory. Cytori sold 224 consumable units in the quarter 2011, also deadon with our expectations for 225. Cytori therapeutics is an emerging cell therapy company focusing on the development of adipose. Cytori precise trial update from the american heart. This was deadon with our forecast, and flat sequentially with the second quarter 2011. Cytori therapeutics completes patient enrollment in phase 3. In the us, cytori is running a key trial, athena in chronic myocardial ischemia. Most of the major indices are now at alltime highs as we publish. Athena evaluated the cobas hpv test as the primary screen for cervical cancer in women. There is a need for understanding the overall mace rate associated with.
We are driven by the pursuit of safe and effective medical devices that improve the health and wellbeing of people. Tractor supply co tsco healthy sales growth, cytori. Mar 16, 2012 safety and feasibility trial of adiposederived regenerative cells in the treatment of chronic myocardial ischemia athena the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Effect of dronedarone on cardiovascular events in atrial. The athena trial is a large cervical cancer screening trial, enrolling 47,208 women 21 years of age or older at 61 clinical sites throughout the united states. Cytx today announced that the results from the athena trials have been published and. How might disaggregated cells cause problems of this nature in this study.
However, there were two likely vascular events in the previous apollo study one. The phase ii athena trial uses celution to produce a regenerative cell mixture to. Clinical trials on eccs50 are currently being conducted to determine if this treatment could improve hand symptoms and function in people with scleroderma. Dec 20, 20 the trial, sponsored by san diegobased cytori therapeutics, derives stem cells from the patients own fat tissue and injects extracted cells into damaged parts of the heart. Cytori athena trials on clinical hold cardiovascular news. Special situations will reward long term investors fellow investor. Cytori therapeutics withholds enrollment in athena trials. Adresu is the worlds first clinical trial for regenerative medicinebased treatment of male stress urinary. A study in ovarian cancer patients evaluating rucaparib. Athena trial hold oct14 us fda knee osteoarthritis trial. Athena hpv trial unique study design the athena hpv trial was a large, prospective clinical study evaluating the performance of the cobas hpv test in three relevant populations.
First dose of iv study drug will be administered on day 1 of cycle 2. I and ii trials, investigating cytori cell use in patients with ischemic. Safety and feasibility trial of adiposederived regenerative cells in the treatment of chronic myocardial ischemia athena the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Cytori therapeutics fourth quarter and fiscal 2015. Triaging hpvpositive women with p16ki67 dualstained. A total of 47,208 women aged 21 years or older undergoing routine screening were enrolled. Cytori therapeutics cytx has placed enrollment in the athena and athena ii trials on clinical hold and therefore anticipates that it will not be possible to complete enrollment of the athena i.
Food and drug administration fda has approved an investigational device exemption ide for a pilot clinical trial to. Cytx ascendiant capital mentioned that the athena trials. All patients had discontinued treatment as of july 25, 20, and the data cutoff for the primary efficacy analysis was aug 18, 2014. Phase ii trial for early stage hair loss read this article along with other careers information, tips and advice on biospace. Information provided by responsible party cytori therapeutics. Cytx announced today the presentation of six and twelve month data from the athena trials at the annual meeting of the society. At this time, all participants have been placed in a listenonly mode and the floor will be open for your questions following the presentation. In terms of our enrolling clinical trials in scleroderma, our star trial which is the 80 patient pivotal phase 3 trial is on track to enroll as planned by middle of the year. Cytori therapeutics is a research client of edison investment research limited.
Cytx announced the presentation of six and twelve month data from the athena trials at the annual meeting of the society for cardiovascular angiography and. A european trial advance in acute myocardial ischemia ami. Patients with distributive shock who require high dose vasopressors have a high mortality. Principal investigator of suspended cytori stem cell trials remains. Clovis oncology announces first patient enrolled in the.
Scripps clinic tests stem cell heart therapy the san. Weight lb per acre number of fruit per acre average fruit weight lb astound 52,501 az 9,922 a 5. One leading trial using a placebo controlled trial design excluded events related to catheterization or injection procedure in the primary analysis. This reports the 3year endofstudy results comparing the performance of hpv primary screening to different screening and triage combinations. Cytori therapeutics athena trial for chronic ischemic. The number and potency of autologous stem cells decline with age and cardiovascular risk factors. Cytori athena trial results support symptomatic benefit from. Cytx today announced that the results from the athena trials have been published and are now available online in catheterization and cardiovascular interventions, a leading international journal covering the broad field of cardiovascular diseases and the official journal of the society for cardiovascular angiography and.
In other words, the cytori product empowers clinics to offer a new product at no incremental discomfort to the patient. Performance of helix transendocardial biotherapeutic. Cytori therapeutics cytx ide approved by fda for pilot. The athena trial is a treatment for chronic heart failure due to coronary heart disease. Cytori halts athena trials over safety concerns wsj. Women were screened using both lbc and hpv dna testing, and all women 25 years of age or older with an abnormal result on either test, as well as a subset of women who were negative on. Technology intended to improve patient care cytori therapeutics. Phase 3 trial of cytoris cell therapy completes 48week. Sep 15, 2005 a trial with dronedarone to prevent hospitalization or death in patients with atrial fibrillation athena the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Pdf cardiovascular diseases, such as coronary artery disease, aortic. Cytori therapeutics athena trial results support symptomatic benefit from cytori cell therapy. Cytx announced today the presentation of six and twelve month data from the athena trials at. Fda decision means a decision by the fda expected to occur on or about october 17, 2014 that results in an outcome pursuant to which the corporation is unable to restart the athena clinical trial without further material changes in the protocol or additional gathering of data resulting in a material delay to the restarting of such. If you start with the initial investment case, cytori has approval of its celution.
Evaluated effect of highdose spironolactone on outcomes including nterminal prob type natriuretic peptide levels in patients with acute hf. Cytori therapeutics fourth quarter and fiscal 2015 earnings. Investment in cytoris cell therapy technology cytori. The athena trial seeks to recruit a total of 45 patients to treat for heart failure and coronary artery disease, which can damage the heart by restricting blood flow. Both fulfillment of the first series of barda contractual milestones and success of the athena trial are pivotal to cytori s outlook.1362 960 31 1323 1299 676 666 7 1130 1038 349 197 1084 1461 1358 263 608 61 1536 382 19 1325 1324 994 1614 916 1131 1169 1432 1103 351 871 146 1289 1301 271