MARKHAM, Canada, October 23 /PRNewswire/ -- Cytochroma today announced that it has initiated a Phase II clinical trial of CTA018 Injection, the Company's product candidate for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD). The Phase II clinical trial is an open label, dose escalating pharmacokinetic, pharmacodynamic, efficacy and safety study of CTA018 Injection in CKD patients with SHPT undergoing hemodialysis.
Joel Z. Melnick, M.D., Cytochroma's Vice-President, Clinical Research and Development, stated, Secondary hyperparathyroidism is a serious condition associated with chronic kidney disease and remains difficult to manage. CTA018 has the unique ability to activate vitamin D signaling pathways as well as inhibit the CYP24 catabolic enzyme. We believe that CTA018 will provide improved control of serum parathyroid hormone without the adverse impact on serum levels of calcium and phosphorus caused by existing agents.
The Phase II study is being conducted in Canada and will enroll approximately 40 hemodialysis patients in a maximum of five dose groups. Each dose group will consist of eight subjects treated for four weeks. Efficacy will be evaluated by the proportion of subjects who achieve at least a 30% reduction in intact parathyroid hormone (iPTH) from pre-treatment baseline. The safety endpoints in this study will include adverse events, physical assessment, clinical laboratory assessment, selected measures of adjusted serum total calcium (Ca), serum phosphorus (P), albumin, calculated Ca x P product, and iPTH.
In a previous Phase I clinical trial, CTA018 Injection was well tolerated and produced clinically meaningful reductions in blood levels of iPTH after less than two weeks of administration. No increases in urinary calcium excretion were seen.
About CTA018
CTA018 is the first compound in a new class of active vitamin D analogs having a novel dual mechanism of action. CTA018 is designed to be a strong activator of the vitamin D signaling pathway as well as a potent inhibitor of CYP24, the intracellular enzyme responsible for the inactivation of vitamin D hormones. Based on its mechanism of action, CTA018 is expected to be safer and more effective in treating SHPT than currently available therapies. This compound was specifically designed by Professor Gary H. Posner, Ph.D. and is protected under patents and patent applications exclusively licensed to Cytochroma from the Johns Hopkins University. CTA018 is partnered with Mitsubishi Tanabe Pharma Corporation under a co-development, and co-promotion arrangement in the U.S., and an exclusive royalty-bearing license in Asia.
About Chronic Kidney Disease
According to the National Kidney Foundation, more than eight million patients in the U.S. suffer from moderate CKD (Stages 3 and 4) to severe CKD (Stage 5). Stages 3 and 4 are characterized by progressively decreasing kidney function as measured by glomerular filtration rate. In Stage 5, kidney function is minimal to altogether absent and patients require regular dialysis or kidney transplant for survival. An estimated 70-90% of CKD patients have vitamin D insufficiency, which can lead to SHPT and resultant debilitating bone diseases. Mounting evidence continues to link vitamin D insufficiency with progression of CKD and death. CKD is caused most frequently by diabetes or hypertension, both of which are consequences of a growing obesity epidemic in countries worldwide.
About Secondary Hyperparathyroidism
SHPT is a condition commonly associated with CKD in which the parathyroid glands secrete excessive amounts of iPTH. This excess iPTH secretion arises as a result of impaired kidneys that are neither able to produce sufficient quantities of active vitamin D hormone nor maintain a state of balance (homeostasis) between calcium and phosphorus in the body. Prolonged elevation of iPTH causes excessive calcium to be released from bone into the blood, leading to softening of the bones (osteomalacia), and calcification of vascular tissues. SHPT affects approximately 90% of severe, and 40-60% of moderate CKD patients.
About Cytochroma
Cytochroma is a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary products to treat and prevent the clinical consequences of Vitamin D insufficiency and SHPT associated with CKD. The Company's Vitamin D-based therapeutics are designed to safely and effectively treat patients with Stage 3, 4 or 5 CKD. Cytochroma has three lead product candidates in development for CKD patients: CTA018 Injection and CTAP201 Injection are being developed for the treatment of SHPT, while CTAP101 Capsules are being developed for the treatment of Vitamin D insufficiency. In addition, Cytochroma is developing novel therapies to treat hyperphosphatemia in these same patients. For more information, please visit http://www.cytochroma.com.
For further information: Cytochroma Investors: Gordon Ngan, Executive Director, Corporate Development, Tel: +1-905-479-5306, ext. 333, gordon.ngan@cytochroma.com; Cytochroma Media: Robert Stanislaro (FD), Tel: +1-212-850-5657, robert.stanislaro@fd.com
For further information: Cytochroma Investors: Gordon Ngan, Executive Director, Corporate Development, Tel: +1-905-479-5306, ext. 333, gordon.ngan@cytochroma.com; Cytochroma Media: Robert Stanislaro (FD), Tel: +1-212-850-5657, robert.stanislaro@fd.com
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