|
NeoPharm, Inc.today announced that it has enrolled its first patient in its Phase I clinical trial for LE-DT, a novel, proprietary liposomal delivery system of docetaxel, the active ingredient of Taxotere(R), which is used for the treatment of patients with metastatic solid cancer
LAKE BLUFF, IL, USA | May 21, 2008 | NeoPharm, Inc. (NASDAQ:NEOL) today announced that it has enrolled its first patient in its Phase I clinical trial for LE-DT, a novel, proprietary liposomal delivery system of docetaxel, the active ingredient of Taxotere(R), which is used for the treatment of patients with metastatic solid cancer.
"We continue to build momentum within our pipeline, as this trial marks our second program that has moved into clinical trials during the first half of 2008. Additionally, the progression of LE-DT further demonstrates the value proposition of our NeoLipid(TM) platform, and provides hope for patients suffering from metastatic solid cancer," commented Mr. Laurence Birch, President and Chief Executive Officer of NeoPharm Inc. "We are encouraged by the results LE-DT has exhibited in pre-clinical analysis, and are pleased to have well-respected organizations, including The Lombardi Comprehensive Cancer Center at Georgetown University and the TGen Clinical Research Services at Scottsdale Healthcare in Scottsdale, AZ, committed to piloting this drug candidate through its initial development cycle."
Docetaxel is a potent antineoplastic agent that functions by inhibiting microtubule disassembly, thereby arresting mitosis. The commercial formulation, Taxotere(R), is approved for breast, non-small cell lung, and androgenindependent prostate cancers. In pre-clinical trials, NeoPharm's liposome entrapped docetaxel (LE-DT) has demonstrated evidence of reducing toxicity profile and increased therapeutic efficacy in human xenograft mouse models.
Dr. Aquilur Rahman, the Company's Chief Scientific Adviser commented, "LE-DT is NeoPharm's new modality of treatment to enter the clinic for Taxotere(R), a chemotherapeutic drug in wide use for the treatment of several forms of advanced cancers, including metastatic breast and ovarian. LE-DT is being developed to eliminate the use of the excipients (solvents) Tween 80 and ethanol, which contribute to an allergic reaction that occurs in most patients, by formulating Taxotere(R), in liposomes."
Dr. Rahman continued, "Patients receiving Taxotere(R) formulated with Tween 80 and ethanol are routinely given antihistamines and steroids prior to treatment to reduce the frequency and severity of these infusion reactions, which could potentially be eliminated by using LE-DT. Additionally, LE-DT may also demonstrate the ability to substantially reduce the toxicities of Taxotere(R), which are dose and treatment limiting."
This open label, dose escalation, Phase I study is designed to determine the maximum tolerated dose (MTD) of LE-DT in patients with metastatic solid cancer who have failed conventional therapy. Up to five dose levels will be studied at up to three investigational sites. NeoPharm anticipates the enrollment of 25 to 30 patients. The secondary objectives of this study will be to evaluate the pharmokinetics of docetaxel following intravenous administration of LE-DT.
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.
SOURCE: NeoPharm, Inc. |
