UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
June 8, 2007 (June 4, 2007)
Date of Report (Date of earliest event reported)
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-16133 | 06-1245881 |
| (State or other jurisdiction | (Commission File No.) | (IRS Employer |
| of incorporation) | Identification No.) |
1100 Summer Street
Stamford, CT 06905
(Address of principal executive offices, including zip code)
Registrant's telephone number, including area code: (203) 323-8668
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a -12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d -2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e -4(c))
ITEM 5.02. DEPARTURE OF DIRECTORS OR CERTAIN OFFICERS; ELECTION OF DIRECTORS; APPOINTMENT OF CERTAIN OFFICERS; COMPENSATORY ARRANGEMENTS OF CERTAIN OFFICERS.
Appointment of Jonathan J. Lewis to the Board of Directors
On June 4, 2007, the Board of Directors of Delcath Systems, Inc. (the “Company”) appointed Jonathan J. Lewis, M.D., Ph.D., to the Company's Board. The Company announced this appointment by press release on June 5, 2007, which is attached as Exhibit 99.1 to this report. Dr. Lewis will serve as a Class III director, which means that his term will expire at the Company’s 2009 Annual Meeting of Stockholders. In addition, it is currently expected that Mr. Lewis will be appointed to serve on the Compensation and Stock Option Committee and the Nominating Committee of the Company’s Board.
The Board has determined that Dr. Lewis is an “independent” director within the meaning of the rules of the NASDAQ Stock Market and the Boston Stock Exchange, the stock exchanges upon which the Company’s securities are currently listed.
Resignation of Dr. Samuel Herschkowitz as Interim Chief Operating Officer
At the Company’s 2007 Annual Meeting of Shareholders on June 5, 2007, the Company announced that Dr. Samuel Herschkowitz, Interim Chief Operating Officer and a Director of the Company, notified the Company that he would be stepping down as interim Chief Operating Officer effective as of July 1, 2007. Dr. Herschkowitz will continue to serve as a Director on the Company’s Board, and has agreed to continue with the Company as a consultant for a period of up to six months.
A copy of the press release announcing Dr. Herschkowitz’s resignation is attached hereto as Exhibit 99.2.
ITEM 7.01. REGULATION FD DISCLOSURE.
At the Company’s 2007 Annual Meeting of Shareholders, the Company announced updates to its clinical trial enrollment numbers. The Company reported that its enrollment for the Phase III trials of the Delcath System for the region-specific delivery of the chemotherapeutic agent, Melphalan, to patients with metastatic melanoma in the liver, increased from 10 to 15 patients, and that three of the patients randomized to the control arm of the Phase III trial have crossed over to receive the Delcath treatment.
In addition, the Company reported that 36 patients have been treated in the Phase II multi-histology trial, and that the overall response rates (complete responses plus partial responses) from the neuroendocrine arm of the ongoing Phase II multi-histology trial for metastatic cancers in the liver increased from 75% to 77% with respect to the 12 evaluable patients previously reported on.
A copy of the press release announcing these updated numbers is attached hereto as Exhibit 99.2.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.
| (d) | Exhibits | |
| 99.1 | Press Release entitled “Jonathan J. Lewis, MD joins Delcath’s Board of Directors,” dated June 5, 2007. | |
| 99.2 | Press Release entitled “Delcath Updates Clinical Trials; Samuel Herschkowitz, MD to Step Down as Interim COO,” dated | |
| June 5, 2007. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned thereunto duly authorized.
| Dated: June 8, 2007 | DELCATH SYSTEMS, INC. | ||
| By: | /s/ Richard L. Taney | ||
| Name: Richard L. Taney | |||
| Title: Chief Executive Officer | |||
EXHIBIT INDEX
| EXHIBIT | DESCRIPTION |
| NUMBER | |
| 99.1 |
Press Release entitled “Jonathan J. Lewis, MD joins Delcath’s Board of Directors,” dated June 5, 2007. |
| 99.2 |
Press Release entitled “Delcath Updates Clinical Trials; Samuel Herschkowitz, MD to Step Down as Interim COO,” dated June 5, 2007. |
Company Contact: |
Investor Relations Contacts: |
JONATHAN J. LEWIS, MD JOINS
DELCATH’S BOARD OF DIRECTORS
STAMFORD, CT JUNE 05, 2007 – Delcath Systems, Inc. (Nasdaq: DCTH) today announced the appointment of Jonathan J. Lewis, MD, PhD to the Company’s Board of Directors. Dr. Lewis is Chief Executive Officer of ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a developer of novel cancer therapeutics with three product candidates in clinical trials.
Dr. Lewis’ academic and medical careers have included leadership positions at the Memorial Sloan-Kettering Cancer Center, Yale-New Haven Hospital, Yale University School of Medicine, Cornell University Medical School, and Antigenics, Inc. where he served as Chief Medical Officer from 2000 to 2003.
Commenting on today’s announcement, Richard L. Taney, Chief Executive Officer of Delcath Systems, said, “We are very pleased to have Dr. Lewis join Delcath’s Board. His training as a surgical oncologist, together with his clinical, research and business experience, are very relevant to Delcath’s needs as we continue to advance the Delcath system toward commercialization and to explore the clinical utility of our system for treating additional organs and administering additional therapeutics.”
Dr. Lewis earned his MB.B.Ch. from Witwatersrand University School of Medicine (Johannesburg, South Africa) and his PhD in Molecular Biology from Witwatersrand and Yale University School of Medicine. Dr. Lewis conducted his Surgical Residency at Johannesburg General Hospital, Witwatersrand University School of Medicine and at Yale-New Haven Hospital, Yale University School of Medicine. He is a Fellow of both the Royal College of Surgeons and the American College of Surgeons. Dr. Lewis was a Research Fellow in the Department of Surgery and Molecular Biophysics and Biochemistry at Yale University School of Medicine, and was a Postdoctoral Fellow in the Department of Immunology and Surgery at Memorial Sloan-Kettering Cancer Center.
Dr. Lewis has received numerous honors and awards, including the American Society of Clinical Oncology (ASCO) Young Investigator Award, Ohse Award from Yale University, Memorial Sloan-Kettering Cancer Center Outstanding Teacher, and has been named in The Best Doctors in America and America’s Best Surgeons, among others. He has authored over 100 publications, written chapters and/or books for over
a dozen medical texts and is a named author on nearly 100 abstracts. A frequent lecturer at national and international cancer societies, Dr. Lewis maintains membership in over a dozen prestigious medical and scientific societies.
About Delcath Systems, Inc.
Delcath Systems is a developer of percutaneous perfusion technology for organ or region-specific delivery of therapeutic and chemotherapeutic agents. The Delcath system is currently being tested with the drug Melphalan in a Phase III trial of patients with metastatic ocular and cutaneous melanoma in the liver and a Phase II trial of patients with primary liver cancers and metastatic tumors in the liver from neuroendocrine cancers and adenocarcinomas. The Company's intellectual property portfolio currently consists of 12 patents on a worldwide basis including the US, Europe, Asia and Canada. For more information, please visit the Company's website www.delcath.com.
This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to our ability to successfully complete Phase III clinical trials and secure regulatory approval of our current or future drug-delivery system and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
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Company Contact: |
Investor Relations Contacts: |
DELCATH UPDATES CLINICAL TRIALS
Samuel Hercshkowitz, MD To Step Down As Interim COO
STAMFORD, CT JUNE 05, 2007 - At its Annual Meeting of Stockholders today, Delcath Systems, Inc. (Nasdaq: DCTH) updated the enrollment numbers for their Phase III trial of the Delcath System for the region-specific delivery of the chemotherapeutic agent, melphalan, to patients with metastatic melanoma in the liver. This trial is ongoing at the National Cancer Institute (NCI) and was recently approved by the NCI for expansion to a multi-center study. Previously, during an investor conference call and webcast in March 2007, the company had reported the enrollment of 10 patients, and, as of today, the company announced that 15 patients have been treated in this Phase III trial. The randomized Phase III trial calls for treatment of 92 patients diagnosed with ocular and cutaneous melanoma metastatic to the liver. Patients are randomized to either the Delcath system using melphalan or a control group receiving best alternative care. The Phase III trial design allows patients whose tumors grow while on the control arm to be crossed over and receive treatment with the Delcath system. The company also informed shareholders that three of the patients randomized to the control arm have crossed over to receive the Delcath treatment.
The company reported that 36 patients have been treated in the Phase II multi-histology trial. This trial, which is also ongoing at the NCI, is testing use of the Delcath System for the region-specific delivery of the chemotherapeutic agent, melphalan, to patients with metastatic neuroendocrine tumors and adenocarcinomas in the liver as well as primary liver cancers. In addition, the company updated earlier reported response rates from the neuroendocrine arm of the ongoing Phase II multi-histology trial for metastatic cancers in the liver. Of the 12 evaluable patients previously reported on, overall response rates (complete responses plus partial responses) of 75% have increased to 77%. These high rates of response are especially encouraging and the Company continues to actively enroll patients in this Phase II trial towards its goal of 25 patients.
The company also today announced that, effective July 1, 2007, Sam Hercshkowitz, M.D., Delcath’s interim Chief Operating Officer, will step down from his current post to
pursue other interests. Dr. Hercshkowitz will remain a Director of the Company and has agreed to continue with Delcath as a consultant for a period of up to six months.
Commenting on today’s announcement, Richard L. Taney, Chief Executive Officer of Delcath Systems, said, “Sam has been instrumental in assuring a smooth management transition at Delcath, in identifying new potential employees and Directors, and has taken the lead on a number of ongoing key projects which he will continue to spearhead in the months ahead. I would like to thank Sam for his contributions over the past six months and look forward to continuing to work together as we advance the Delcath System toward commercialization.”
About Delcath Systems, Inc.
Delcath Systems is a developer of percutaneous perfusion technology for organ or region-specific delivery of therapeutic and chemotherapeutic agents. The Delcath system is currently being tested with the drug Melphalan in a Phase III trial of patients with metastatic ocular and cutaneous melanoma in the liver and a Phase II trial of patients with primary liver cancers and metastatic tumors in the liver from neuroendocrine cancers and adenocarcinomas. The Company's intellectual property portfolio currently consists of 12 patents on a worldwide basis including the US, Europe, Asia and Canada. For more information, please visit the Company's website www.delcath.com.
This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to our ability to successfully complete Phase III clinical trials and secure regulatory approval of our current or future drug-delivery system and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
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