NeoPharm Inc has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for Liposome Encapsulated SN38 (LE-SN38).
As a result of the IND submission, NeoPharm hopes to enter into Phase I/II human clinical trials by the end of this year. This would be NeoPharm's sixth novel cancer treatment to enter clinical testing in the last four years, and the fourth NeoLipid compound to enter clinical testing during the same period. NeoPharm has designed LE-SN38 in an easy-to-use (ETU) formulation to minimize preparation time and improve administration of the drug.
SN38 is the active metabolite of CPT-11 (irinotecan), a chemotherapeutic pro-drug marketed as Camptosar in the U.S. (Pharmacia) which has been approved in the United States for the treatment of metastatic colorectal cancer. CPT -11 is marketed by Aventis in Europe, and Yakult as well as Daiichi in Japan.
NeoPharm is planning to use LE-SN38 to treat other types of cancers (in addition to colorectal) with an agent that would have a safety and efficacy advantage over CPT -11. At the present time, without the NeoLipid system, SN38 is insoluble and can only be used to treat cancer by administering the pro-drug, CPT- 11. A pro-drug is a compound that is converted into the active drug in the body. Only 6-12 per cent of CPT -11 is converted into SN38 in colorectal cancer cells and can be very toxic to the patient.