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San Diego's Cytori Therapeutics, Inc. (CYTX) Crashes As Safety Concerns Suspend Athena Trials


8/1/2014 2:13:43 PM

San Diego's Cytori Therapeutics, Inc. Crashes As Safety Concerns Suspend Athena Trials San Diego's Cytori Therapeutics, Inc. Crashes As Safety Concerns Suspend Athena Trials
Shares Plunge Nearly 29 Pct After Trading Halt

August 6, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff

Cytori Therapeutics, Inc. (CYTX), a medical technologies company focused on regenerative medicine, saw its share price plunge nearly 29% yesterday after it announced the suspension of trials for products ATHENA and ATHENA II. In after hours trading, the company’s stock price fell 60 cents to $1.50.

The company decided to place the trials on hold after three patients experienced cerebrovascular events—those related to blood vessels in the brain. No details on the events were given, however, according to the company, two patients have fully recovered and one “has had substantial resolution of symptoms.”

Working with the FDA, an independent Data Monitoring Committee (DMC), and trial investigators, Cytori Therapeutics has stated its goal to thoroughly understand the symptoms experienced by the patients and to make the necessary adjustments in its products to improve their safety. The company has not, however, given a timeline for resumption of the trials, short of saying that it will not be able to complete enrollment in ATHENA I trials by the end of 2014.

The ATHENA trials are testing a novel treatment for heart failure patients with ischemic heart disease. Ischemia, a vascular disease, is caused by an interruption in blood supply to a tissue or organ. ATHENA has been developed for patients who have no other option for revascularization—the restoration of blood flow to affected areas.
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While revascularization is often achieved via surgery (for example, heart bypass), Cytori Technologies, in the form of ATHENA, is attempting to use autologous adipose-derived regenerative cells (ADRCs™) to do so. The procedure involves harvesting the patient’s own fat (adipose) tissue, because adult stem and regenerative cells naturally reside there. According to the company, “Our scientific data suggest ADRCs improve blood flow, moderate the inflammatory response and rescue tissue at risk of dying.”

The ATHENA trials were complex because they involved more than simply administering a medication. First, the patient’s fat was harvested via liposuction. Next, the patient underwent heart catheterization and electromechanical mapping of the heart with the goal of identifying where to inject the ADRCs. In the trial, which was double-blind and randomized, patients received either the ADRCs or a placebo at this point.

All trials involving patients with the most serious diseases present a specific set of risks, one of which is co-morbidity, or the existence of multiple conditions in one patient, sometimes caused by the initial disease, sometimes not. It can be difficult to assign a cause-effect relationship between a treatment and a disease if more than one disease is involved. Determining the safety and efficacy of a treatment for a specific disease rests on the assumption of a clear cause-effect between the two. This is not always possible with a population suffering from multiple health conditions. Cytori Techologies claims that co-morbidity could be the cause of the cerebrovascular events that occurred in participants of the ATHENA trials.

At this time, the stock price is up 15 cents from this morning’s opening of $1.49.

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