Liposome paclitaxel found safe for advanced breast cancer in Indian clinical studies: NeoPharm

Liposome-Entrapped Paclitaxel, a safer version of the anti-cancer drug paclitaxel, has been found effective in treating advanced breast cancer in clinical trials conducted in India.

Liposome-Entrapped Paclitaxel is liposomal formulation of the widely used cancer drug, paclitaxel developed by  NeoPharm.

Paclitaxel, also known as Taxol by Bristol-Myers Squibb Company, has been approved in the US for the treatment of ovarian, breast and lung cancers.

Despite paclitaxel’s wide use and its tumor cytotoxic characteristics, its effectiveness can be limited by its adverse side effects, which can include nausea, vomiting, hair loss and nerve and muscle pain.

Paclitaxel, it cannot be introduced into the body unless it is first formulated in a mixture of castor oil (Cremophor) and ethanol, which can lead to significant side effects such as hypersensitivity reactions and cardiac toxicities, because of the chemical characteristics of the drug.

NeoPharm’s NeoLipid technology eliminates the need for Cremophor and ethanol, permits delivery of paclitaxel treatment with fewer side effects.

NeoPharma conducted a multicenter, open-label trial of Liposome-Entrapped Paclitaxel at 5 centers in India.

Thirty-five subjects were enrolled and received Liposome-Entrapped Paclitaxel doses of 275 mg/m2 administered over 90 minutes every 21 days without routine prophylactic pre-medication for infusion-related reactions.

Subjects received a median of 6 cycles (range 2 to 10) with 22 subjects receiving ? 6 cycles. Overall tumor responses with fully audited data were as follows: 16 subjects (46%) with tumor response including 15 partial responses and one complete response; 10 subjects (29%) with stable disease (mean duration, 6 cycles; range, 2-10 cycles); 9 subjects (25%) with progressive disease.

Liposome-Entrapped Paclitaxel was well tolerated. No significant infusion-related reactions were observed as indicated by adverse events or prophylactic pre-medication use.

“A response rate of 46% (partial and complete responses) is quite noteworthy in this heavily pretreated patient population with advanced breast cancer,” stated Dr Aquilur Rahman, President and Chief Executive Officer of NeoPharm.

In addition, if responses and stable disease are considered together the potential clinical benefit may extend to 75% of patients, he added.

In the first quarter of 2009, NeoPharm completed the targeted enrollment of 35 patients for the first part of its Phase II open-label, multicenter outpatient study in India designed to evaluate the anti-tumor effect and safety/ tolerability of LEP-ETU in metastatic breast cancer.

NeoPharm submitted a request to the Directorate General of Health Services – Office of Drugs Controller General (India) (DCGI) in February 2009 to expand the targeted enrollment to 70 patients with recurrent breast cancer.

On July 16, 2009, NeoPharm received notification from DCGI that its request to expand the Phase II study to an additional 35 patients has been approved, and patient enrollment is expected to begin by August 2009.

In June 2009, NeoPharm engaged an independent clinical trial firm in India to audit the results of the 35 patients enrolled in the first part of the Phase II study.

All of the patients in the first part of the study have received a dose of 275 mg/m2 ev
ery three weeks without the detection of any signifiant infusion related problems or unexpected toxicities with significant response rate.

Located in Lake Bluff, Illinois, NeoPharm is a publicly traded biopharmaceutical company engaged in the research, development, and commercialization of drugs for the treatment of various cancers and other diseases.