Delcath's shares up 31% upon release of postive clinical data!!!

URGENT UPDATES

- Pivotal study compared PHP to best alternative care

- Results surpass primary endpoint expectations
- DCTH to initiate rolling NDA submission in the next 30 days
- Shares hiked 31% in after-hours trade


Delcath Systems Inc. (DCTH) announced today that their pivotal phase III clinical study results have met the main study objective of demonstrating the efficacy of slowing cancer progression in the liver of patients with melanoma metastasizing to the organ.

In this study, Delcath's PHP (Percutaneous Hepatic Perfusion) system used with chemotherapy drug melphalan was tested against best alternative care. Based on the positive trial findings, DCTH expects to initiate their rolling NDA (new drug application submission) to the FDA within the next 30 days.

After detailed analysis to the study results, it was reported that PHP patients had a statistically significant longer median hepatic progression-free survival of 214 days compared with 70 days in the best alternative care arm. The company added, on a conference call, that while they were expecting the best alternative care arm to show progression-free survival of around 4 months instead of around 2 months, the PHP arm still produced a remarkable improvement in patients, showing progression-free survival of 7 months. The trial results certainly came as a pleasant surprise as patients, experiencing rapid disease progression, who crossed over from the best alternative care arm to the PHP treatment arm performed even better than those with 'milder' conditions.

"This certainly puts them on a good start," Craig-Hallum Capital analyst Brooks West commented on Delcath's odds of obtaining a regulatory approval, especially when the trial was run according to a special protocol assessment, which provides a company with a written agreement that the design and analysis of the trial are adequate to support a marketing application submission with the U.S. health regulators.

On June 5, the company will further announce news regarding overall patient survival as part of the trial's secondary end points at the annual meeting of the American Society of Clinical Oncology.

The PHP system is priced at $20,000/system at the moment and sees estimated revenue of $745 million in the US market alone.

Shares of the company were up 30.78 percent to $14.19 in after-hours trade. DCTH closed at $10.85 Wednesday on Nasdaq.