Rockwell Medical Technologies Finalizes Proprietary Iron-Delivery Product Phase III Clinical Trial Protocol For FDA Submission; Commences Non-Clinical Development Program
WIXOM, Mich., Jan. 11 /PRNewswire-FirstCall/ -- Rockwell Medical Technologies, Inc. , a leading, innovative dialysis products manufacturer serving the healthcare industry, reported today that it has completed its Phase III Clinical Trial protocol for its proprietary Iron-Delivery Product (Soluble FePPi) for Physiological Iron Replacement in Patients on Hemodialysis. Several non-clinical safety studies are also underway in support of the product's development.
Rockwell's Phase III Clinical Trial protocol has been finalized and is scheduled to be submitted to the FDA during the second quarter 2006. This prospective, randomized, double-blinded, multi-center, controlled clinical trial will evaluate Soluble FePPi, delivered via dialysate solution, as a physiological iron replacement in patients undergoing chronic hemodialysis. Pending FDA approval of its development plan, the Company anticipates initiating the Phase III Clinical Trial during the third or fourth quarter of 2006.
Currently, a battery of non-clinical studies to support the initiation of the Company's Phase III Clinical Trial is underway. To date, six of fourteen studies have started. The remaining eight are planned to begin during the first quarter of 2006. Three genetic toxicity studies are scheduled to be completed in Q1 2006. A preliminary reproductive toxicology study and a safety pharmacology study for central nervous system effects are to be completed in Q2 2006. A safety pharmacology study of cardiovascular effects is scheduled to be completed in Q3 2006. Five studies, including reproductive toxicity studies and three-month repeat-dose toxicity studies are to be completed in Q4 2006. The entire battery of non-clinical studies is projected to be complete in Q1 2007 when the results of a six and nine month repeat-dose study and an embryonic and fetal development study are expected to become available.
Also, a NIH-funded study is scheduled to begin March 2006. This academic study, separate from the Phase III Clinical Trial, will evaluate Soluble FePPi, delivered via dialysate solution, for physiological iron replacement in chronic hemodialysis patients. The study will evaluate the safety and effectiveness of Soluble FePPi with regards to the incidence and time to development of iron deficiency, the severity of iron deficiency and the amount of intravenous (IV) iron required. This study will evaluate the markers of inflammation and oxidative stress, considered to be integral processes in progression of end-stage renal disease (ESRD). Fifteen patients will be given Soluble FePPi via the dialysate and fifteen will receive conventional dialysate that does not contain iron.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We are pleased to have completed our Phase III Clinical Trial protocol as well as to have made substantial progress on our non-clinical supporting studies. We will continue to accelerate our development progress and strive to attain FDA approval as quickly as possible. We are truly excited about this innovative product which has the potential to be one of the most significant advances to affect the dialysis market in the last 20 years."
Rockwell has licensed the patent rights to Soluble FePPi; Physiological Iron Replacement for Patients on Hemodialysis. Soluble FePPi is a proprietary, innovative and potentially ground-breaking iron-delivery product. Currently in development, Rockwell's Soluble FePPi will deliver iron to the dialysis patient via the Company's dialysate product line. Once approved by the FDA, the Company believes its Soluble FePPi will compete aggressively in the $300 million U.S. IV-Iron market.
Compared to the current IV-iron products used today, Rockwell's proprietary Soluble FePPi is believed to be safer and more effective and provides a substantial improvement in the quality outcomes for dialysis patients with iron deficiency. Soluble FePPi, delivered via dialysate, has a distinct patient-safety advantage in that it transfers the iron load directly from dialysate into the blood plasma (not into the liver thereby avoiding liver damage) and it is carried directly to the bone marrow for the formation of new red blood cells -- the kinetic properties of the compound enable the rapid uptake of iron in blood plasma. Furthermore, the greater frequency and smaller dosage of Soluble FePPi maintains iron stores in a more effective and steady state which should produce a superior therapeutic response from Epoetin alfa treatment, as compared to IV-iron.
In addition, Soluble FePPi, delivered via Dialysate, will produce substantial cost savings by eliminating nursing time and supplies needed for current IV-iron drug administration. Cost and liability due to potential needle-stick risk will also be eliminated.
Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing, marketing, and delivering high-quality dialysis solutions, powders, and ancillary products that improve the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and suffer from chronic kidney failure, a condition also known as end stage renal disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 6%-8% on average each year over the last decade. Rockwell's products are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell offers the proprietary Dri-Sate(R) Dry Acid Concentrate Mixing System, RenalPure(R) Liquid Acid Concentrate, SteriLyte(R) Liquid Bicarbonate Concentrate, RenalPure(R) Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items. Visit Rockwell's website at http://www.rockwellmed.com for more information.
Certain statements in this press release with respect to Rockwell's business and operations, including statements regarding an anticipated response from the FDA on the Company's Phase III Clinical Trial proposal, non-clinical study timelines, FDA approval, the potential of Rockwell's proprietary Soluble FePPi, etc., and the Company's ability to raise additional capital constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.Rockwell Medical Technologies, Inc.
CONTACT: Thomas Klema of Rockwell Medical Technologies, Inc.,+1-248-960-9009
Web site: http://rockwellmed.com/