Medical research firm Delcath Systems Inc. said Wednesday that preliminary results from a study of its liver cancer treatment device exceeded expectations.
The startup recently concluded clinical trials for its PHP System, which uses catheters to isolate the liver from the patient's circulatory system before delivering a concentrated drug to the organ.
Early data show the device outperformed the best available care options by keeping patients' cancer from worsening and keeping the patients alive longer, company officials said in a conference call Wednesday evening.
According to Delcath, patients treated with the PHP System went almost three times longer without progression of their cancer than the control group who received other treatments.
The study's hazard ration was 0.46, which means the PHP patients had less than half the risk of progression or death than those receiving the best alternative care.
Delcath CEO Eamonn Hobbs said the data support the company's believe that PHP will be a better and less invasive treatment option for patients suffering from melanoma metastases in the liver.
"We easily exceeded our expectations of clinical trial success," Hobbs said. "This is a major step forward in our plan to introduce what we believe is an effective treatment for patients who currently have very few viable options."
Delcath, which is headquartered in New York City and has a production facility in Kingsbury, will use the results of the study to move forward with the U.S. Food and Drug Administration approval process. Once approved, Delcath can begin selling and marketing the device.
In the meantime, Delcath is working to build its partnerships abroad.
"With this event, we'll be able to turn up the heat and pursue strategic partnerships in Asia, particularly," Hobbs said.
Delcath believes the device, used in conjunction with the drug melphalan, has a U.S. market potential of $745 million. As a platform technology to be used in the treatment of other types of cancer and with other drugs, the U.S. market is $5.5 billion, Hobbs said.
Delcath plans to pursue other uses for the device; however, it will have to seek separate FDA approvals for the treatment of different organs, as well as for use with different medications.
Hobbs said the FDA suggested during a recent meeting that Delcath package the melphalan drug and the delivery system together to ensure it is used in the appropriate manner.
The company expects to start its FDA submission within a month and to receive approval by the middle of 2011. European Union approvals could come earlier that year, Hobbs said.
The full results of the recent study will be presented at a meeting of the American Society of Clinical Oncology in June.