|Delcath (NASDAQ: DCTH): Significant 1H10 Catalysts Await|
|Friday, 08 January 2010 11:01|
Delcath Systems (NASDAQ: DCTH) is an emerging, small-cap medical device innovator that is developing a regional treatment system for cancer in the liver. Delcath's Percutaneous Hepatic Perfusion (PHP) technology allows physicians to deliver significantly higher doses of existing chemotherapy drugs to the liver without exposing each patient's entire body to the anti-cancer drugs, representing an elegant solution that promises to increase the effectiveness of approved anti-cancer drugs while reducing systemic side effects.
Last August, Delcath announced that the FDA granted orphan drug status to doxorubicin, an approved chemotherapy agent, for the treatment of primary liver cancer. The Company said it tested doxorubicin with its unique drug delivery technology, Percutaneous Hepatic Perfusion (PHP), which results in significantly higher doses (e.g. 10X the FDA approved standard dosing with 100X exposure of drug to the tumor site) of anti-cancer drugs such as doxorubicin to the liver without exposing the patient's entire body. Delcath plans to carry out the necessary clinical work for a regulatory submission of PHP with doxorubicin.
Last October, the pivotal Phase 3 Metastatic Melanoma Trial met its goal of 92 patients and was fully enrolled. This clinical study is evaluating the Delcath PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic cutaneous and ocular melanoma who have unresectable tumors in the liver. Enrollment in the Phase 2 clinical study of the Delcath PHP System with melphalan for patients with inoperable liver metastases from neuroendocrine tumors reached 25 patients last fall and continues to enroll patients with guidance at that time for data to be reported in the coming months.
Some other developments and expected 1H10 milestones for DCTH are outlined below.
1.) Established a low-cost operation facility in Queensbury, New York in which Delcath plans to locate manufacturing of its PHP System.
2.) Active negotiations continue with several international entities to provide exclusive geographic market rights for the PHP System.
3.) DCTH expects to submit an application for FDA medical device marketing clearance (PMA) of the PHP System with melphalan by mid-2010 and is optimistic about its ability to gain CE Mark approval in Europe in early 2010 with commercial sales in the European markets starting shortly thereafter.
4.) DCTH significantly strengthened its balance sheet last year with the closing of also closed a public common stock offering for proceeds of about $32.4 million last year.
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Disclosure: Long DCTH