Delcath Systems Inc. (NSDQ:DCTH) saw share prices drop 11 percent on news that its flagship cancer therapy device presented inconclusive results in treatment of colorectal cancer.
Sixteen patients with very late stage colorectal cancer participated in Delcath’s phase II study of its Chemosat focused chemotherapy delivery system, which uses a series of tubes to aim chemotherapy drugs at a specific organ and then filter the blood to remove the toxins before returning it to the body.
"No significant responses were noted among these patients as they had been heavily pre-treated with numerous chemotherapeutic and regional modalities that, along with anatomical and disease-related factors in a few, prevented sufficient melphalan exposure," according to a press release.
The New York-based company also noted that the trial, conducted at the National Cancer Institute, was not designed for patients with such late-stage cancers, and that a new phase II trial should be conducted with a new colorectal patient population.
The study results, which were released Sept. 1, brought share prices down 11 percent by the end of the day to $3.68 from the prior day’s close at $4.14. Delcath stock has been quite a roller coaster over the past year, a volatility that CEO Eamonn Hobbs attributed to the demographics of the shareholder base.
"Delcath is an extremely volatile stock and there a number of components to that. One is that it’s a stock that’s shareholder based, that’s dominated by retail shareholders who tend to be much more active traders," Hobbs told MassDevice. "The trading volume is high and the volatility seems to be equally high. The stock seems to go up significantly on good news and down significantly on bad news — or no news."
Shares were trading at $3.69 this morning, a 3 percent drop from yesterday’s close at $3.81.
Chemosat won CE Mark approval in the European Union for treatment of liver cancer in April, Hobbs told MassDevice in June, but the device has suffered some regulatory hiccups on the way to FDA clearance.
"We expect to have regulatory approval in countries in Asia, South America, Central America and Canada, the Middle East and Africa starting in 2012," Hobbs said. "We should have regulatory approval in virtually all the countries by the end of 2013."