LAWRENCE, KS – CritiTech, a growing drug delivery and development company, announced today positive results from the Phase I Trial of Nanotax® (“Trial”), a novel fine particle reformulation of paclitaxel to treat intraperitoneal cancers. The Trial, conducted at three clinical sites headed up by the National Cancer Institute Designated University of Kansas Cancer Center was designed to study the safety and pharmacokinetics in 21 patients with advanced peritoneal (“IP”) cancers.
“We are excited by the safety and pharmacokinetics outcomes from the Phase I Trial,” said Dr. Charles Decedue, Chief Scientific Officer at CritiTech. “The study results demonstrated that Nanotax® was very well tolerated, and there were no serious adverse events related to the drug. The data also showed evidence of high paclitaxel concentrations in the peritoneal cavity, extended drug release exposing tumors to higher concentrations of drug over a longer period of time, as well as substantially lower systemic exposure compared to intravenous injection of paclitaxel. With guidance from the U.S. Food and Drug Administration, we are looking forward to initiating the next steps to continue to advance Nanotax®.”
The safety and pharmacokinetic profile in the Phase I Trial is consistent with pre-clinical studies. In pre-clinical rat studies, Nanotax® had a ten-fold higher maximally tolerated dose compared to Taxol®. Delivered intraperitoneally in a mouse ovarian cancer model, Nanotax® significantly increased overall survival when compared to equal doses of Taxol®. In addition, substantially higher doses of Nanotax® compared to Taxol® could be delivered to the mice without noticeable toxicity.
About the Nanotax® Phase I Trial
Phase I Trial patients had relapsed solid IP tumors and adequate organ function. The primary malignancy was ovarian cancer (74%). Nanotax® was administered IP as a bolus injection after 500 ml saline followed by IP administration of up to 2 L of saline. The pharmacokinetics of IP administered Nanotax® were characterized in plasma and peritoneal fluid. Patients were treated at dose levels from 50 – 275mg/m2 every 28 days. Treatment was well tolerated. Pharmacokinetic data demonstrate significant, persistent IP exposure to Nanotax® at higher concentrations (~1,000X) compared to intravenous paclitaxel administration, with minimal systemic exposure and enhanced safety compared to Taxol®.
Nanotax® has been developed for the treatment of intraperitoneal carcinomas (e.g., ovarian cancer, pancreatic cancer, colorectal, liver, bladder, etc.) and is delivered via direct injection into the abdominal cavity. Nanotax®, is a Cremophor®-free, fine-particle reformulation of paclitaxel, developed by CritiTech using its proprietary fine-particle drug reformulation and production technology. Cremophor®, polyethoxylated castor oil, is the excipient used to deliver the poorly soluble paclitaxel (Taxol®) that is delivered intravenously. Some of the side effects associated with Taxol® include nausea, vomiting, diarrhea, blurred vision, difficulty swallowing, painful or difficult urination, ulcers or sores in the mouth, thinned or brittle hair, pain in the joints of the arms or legs, tingling in the hands or toes, unusual bruising or bleeding/pain/ redness/swelling/ blistering/infection/swelling at the injection site, change in normal bowel habits, fever, chills, cough, sore throat, difficulty swallowing, dizziness, shortness of breath, exhaustion, skin rash, itching, facial flushing, et. al. (see www.drugs.com).
CritiTech’s goal is to develop Nanotax® as a safer, better tolerated and more effective formulation of paclitaxel than those available on the market today
CritiTech, Inc. is a drug delivery and development company focused on using the company’s proprietary Supercritical Fluid (“SCF”) Technology to help its clients and partners develop and manufacture unique and differentiated drugs and medical devices. CritiTech specializes in optimizing the delivery of challenging drug substances, potent molecules and poorly soluble compounds. By combining its SCF Technology with its ability to simplify formulations, CritiTech can expand and improve the drug delivery options for oral, injectable, and inhaled drugs, as well as implantable devices.