NeoPharm Presents the Phase I Data for Patients with Metastatic Solid Tumors
LAKE BLUFF, Ill.--(BUSINESS WIRE)--Nov 17, 2009 - NeoPharm, Inc. (Other OTC: NEOL.PK) today announced the results of a Phase I clinical trial of Liposome Encapsulated Docetaxel (LE-DT) an active component of Taxotere® at a joint International Conference of the American Association for Cancer Research (AACR), the National Cancer Institute (NCI) and the European Organization for Research and Treatment of Cancer (EORTC) being held in Boston, MA. This multicenter, open label dose escalation trial of LE-DT was performed at Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC and Scottsdale Clinical Research Institute/TGEN, Scottsdale, AZ.
Patients received 50, 65, 85, 110 and 132mg/m2 doses in a cohort of 3 patients per dose until the maximum tolerated dose (MTD) was defined. The MTD was determined to be 110 mg/m2 with growth factor support (9 patients). Neutropenia was the most common toxicity seen in patients receiving higher doses of LE-DT, which is also observed with Taxotere®. Additionally, toxicities experienced by at least three patients included fatigue, alopecia, rash and diarrhea. Most of the non-hematological toxicities observed with LE-DT were grade 1 in nature. Of particular note, in this heavily pretreated cancer patient population, no patient was observed with clinically significant neuropathy, even those patients who received 15 cycles (110mg/m2) and 24 cycles (50mg/m2) of LE-DT. Ten patients experienced some form of infusion-related reaction with LE-DT including chills, rigor, back pain or nausea which was managed by slowing the rate of infusion, except in a few patients who needed antihistamine support. Also, an additional observation was that none of the patients experienced clinically significant edema, which is the common toxicity of Taxotere® when given with Tween 80.
Dr. Aquilur Rahman, President and Chief Executive Officer of NeoPharm commented, “We are very pleased with the absence of serious toxicities with LE-DT therapy for the majority of cancer patients in this trial, particularly peripheral neuropathy and edema, the two treatment limiting toxicities observed with Taxotere®. We are encouraged with the clinical response of LE-DT in this heavily pretreated cancer patient population suffering from various kinds of cancers. A response rate of 45% (partial response and stable disease) is quite noteworthy. We look forward to the clinical outcome of LE-DT in pancreatic and prostate cancer patients in Phase II trials which are being initiated.”
About NeoPharm, Inc.
NeoPharm, Inc., based in Lake Bluff, Illinois, is a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative cancer and other drugs for therapeutic applications. Additional information, including ongoing clinical trials, can be obtained by visiting NeoPharm's Web site at www.NeoPharm.com.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," “projects,” "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to, any statements relating to the Company's drug development programs, the initiation, progress, and outcomes of clinical trials of the Company's drug product candidates including, but not limited to LE-DT, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, risks and uncertainties relating to difficulties or delays that may arise in the development, testing, regulatory approval, production, and marketing of the Company's drug and non-drug compounds, including, but not limited to, LE-DT, the Company's possible need to reduce its funding of certain of its development projects in order to conserve its cash resources, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug product candidates, including, but not limited to, LE-DT, that could slow or prevent products coming to market, uncertainty regarding the Company's ability to commercialize any of its drug product candidates, including, but not limited to, LE-DT, and other risks of the type previously detailed from time to time in filings the Company formerly made with the Securities and Exchange Commission (“SEC”). Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release. At the Company's request, the Company's obligation to file reports with the SEC was suspended effective February 12, 2009. For the foregoing reasons, you should not rely on these forward-looking statements or our previously filed SEC reports as a prediction of actual future results.
Contact: NeoPharm, Inc.
Posted: November 2009