per WUWT on the fireworks thread...
STAMFORD, Conn., June 3 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH; DCTHW; DCTHZ) reported that National Cancer Institute (NCI) researchers using its technology achieved anti-tumor activity in 75 percent (6 of 8) of subjects with inoperable metastatic liver cancers that began as ocular melanoma.
Tumors in three of the subjects either stabilized or shrank 25-50 percent, two experienced greater than 50 percent shrinkage and one subject's tumor all but disappeared, leaving him tumor-free for 10 months, considerably longer than his expected survival, researchers said.
The study was conducted to determine the optimal dose of the popular cancer drug melphalan using Delcath's novel technology, an advanced form of controlled drug delivery designed to allow aggressive chemotherapy while preventing the serious side effects that have historically limited the use of high-dose treatments.
The findings showed that melphalan can be used much more aggressively than originally thought, and investigators reported encouraging efficacy at the higher dose levels. No unmanageable toxicities were reported. At the highest study level, patients received melphalan in doses roughly eight times the normal amount, confirming that strategies for high-dose chemotherapy against inoperable tumors can be pursued with greater safety than was previously thought possible.
While the findings showed the highest success rate occurred in patients with metastatic ocular melanoma, a full 40 percent of all other patients -- all with some form of metastatic liver cancer -- experienced either anti-tumor activity or clinically significant tumor reductions. A total of 18 subjects have been evaluated thus far. Three additional patients remain on treatment at the highest dose, too early to be evaluated for tumor response.
Data from the on-going study were presented Sunday June 1 at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago by Drs. H. Richard Alexander, principal investigator and head of the NCI's Surgical Metabolism Section and James F. Pingpank, Jr., associate investigator, in a presentation titled "A Phase I Feasibility Study of Hepatic Arterial Melphalan Infusion with Hepatic Venous Hemofiltration Using Percutaneously Placed Catheters in Patients with Unresectable Hepatic Malignancies."
The findings detail a methodical hunt for the optimal dose of melphalan, a widely used cancer agent, in fighting inoperable metastatic cancers lodged in the livers of patients who generally have short life expectancies, often less than nine months.
The Delcath system delivers high-dose chemotherapy directly to the liver via the hepatic artery. As blood exits the liver, special Delcath filters trap the chemotherapy, protecting the rest of the body from excessive toxicity. The procedure is repeatable and less invasive than traditional ways of performing isolated perfusion to effect dose-directed therapy of specific body organs or regions.
The NCI study classified clinically significant responses in three categories: (1) tumor shrinkage of 25 to 50 percent; (2) tumor shrinkage greater than 50 percent; and (3) complete response with no measurable tumor.
Among the preliminary findings and comments:
* 33 percent (six of the 18 evaluated patients) experienced either disease stability or tumor shrinkage of 25 to 50 percent.
* 22 percent (four of the 18) achieved either complete response (one) or saw their tumors shrink more than 50 percent.
* Six of eight of the study subjects with primary ocular melanoma responded favorably, suggesting certain cancers may respond better than others. One patient has not yet been evaluated and one patient experienced tumor progression.
* The longest duration of response (shrinkage or stabilization) was 10 months in a subject with ocular melanoma. The researchers considered this particularly significant because the subject had a life expectancy of two to six months.
* None of the three additional patients at the highest dose (3.5mg/kg) have yet been evaluated for anti-tumor activity; all three remain under treatment. Two of the three received treatment doses exceeding 250 mg, which researchers characterized as "extremely high" and equal in strength to doses used in conjunction with autologous bone marrow transplant procedures.
* One patient received two cycles of four treatments, resulting in a total of eight isolated perfusions, demonstrating the repeatability of the procedure.
"The NCI's study shows that old weapons -- in this case melphalan -- can be put to new and even more productive use if you can control toxicity," said M.S. Koly, CEO of Delcath. "This marks a new era for more aggressive use of toxic cancer chemicals. Dr. Alexander and his team at NCI are proving that chemotherapy has a bright future, bringing new hope to cancer patients and their families."
Consistent With Earlier Studies
The company said the NCI's results follow and in some cases improve on the tumor response trends experienced in earlier Phase I/Phase II studies at MD Anderson and also Yale Medical School where the technology was first tested.
The labeled dose of melphalan is under 0.5 mg/kg. Because of the manageable nature of toxicities observed within the study, the NCI gradually increased the dose to 3.5mg/kg. Three patients are being treated at this dose but it's too early to evaluate anti-tumor activity, the researchers said.
The researchers reported there was minimal hepatic toxicity at all dose levels.
All patients admitted to the NCI study had inoperable metastatic cancers in the liver. Six of ten responding patients had primary ocular melanoma. The four other primary cancers were breast, pancreatic, neuro-endocrine and adrenal-cortical.
The NCI is currently planning a Phase II study with the Delcath system and melphalan to treat patients with primary hepatic tumors and metastatic liver cancer originating from either adenocarcinoma (GI, breast, lung), neuro-endocrine, or melanoma (ocular and cutaneous) cancers. Accrual is expected to begin shortly.
Delcath is a developer of isolated perfusion technology for organ or region-specific delivery of therapeutic agents. Its technology is covered by six US, and three foreign issued patents. The company is headquartered in Stamford, CT.
This release contains "forward-looking statements" based on current expectations but involving known and unknown risks and uncertainties. Actual results or achievements may be materially different from those expressed or implied. Delcath plans and objectives are based on assumptions involving judgments with respect to future economic, competitive and market conditions, its ability to consummate, and the timing of, acquisitions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond its control. Therefore, there can be no assurance than any forward-looking statement will prove to be accurate.
CONTACT: M.S. Koly, Chief Executive Officer of Delcath Systems, Inc., +1-203-323-8668; or Thomas Redington of Redington, Inc., +1-203-222-7399, or +1-212-926-1733, for Delcath Systems, Inc. |
