The United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for US Patent Application No. 13/244,945 to Cytochroma, an Ontario, Canada-based clinical stage specialty pharmaceutical company.
This patent application, entitled “Method for Treating Secondary Hyperparathyroidism in CKD”, covers the anticipated method of use of the company’s lead product, CTAP101 capsules, which is in phase III development for treating patients with Stage 3 or 4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.
CTAP101 capsules has been evaluated in four clinical studies to date, including a phase II b study which ended in late 2011. The positive results obtained in the phase II b study will be highlighted at a medical conference later this year.
“We are pleased to reach yet another significant milestone for CTAP101 capsules and be one step closer to introducing this important new medication for chronic kidney disease patients suffering with secondary hyperparathyroidism and vitamin D insufficiency, a sizable population with few treatment options,” commented Dr Charles W Bishop, president and CEO of Cytochroma. “This newly allowed patent application will help ensure protection for CTAP101 Capsules from generic competition until 2028.”
CTAP101 Capsules is being developed as a first-in-class treatment for patients with Stage 3 or 4 CKD with SHPT and vitamin D insufficiency. The product is designed to reliably correct vitamin D insufficiency by raising serum vitamin D pro-hormone concentrations to adequate levels (30 ng/mL or higher), thereby lowering elevated plasma parathyroid hormone (PTH) without the side effects often associated with vitamin D hormone therapies.
CKD is characterized by a progressive decline in kidney function. The kidney normally removes waste and excess water from the blood and regulates circulating vitamin D hormones. As CKD advances, blood levels of vitamin D prohormones and hormones decrease, causing vitamin D insufficiency and SHPT. CKD is classified in five different stages – mild (stage 1) to severe (stage 5) disease – as measured by glomerular filtration rate.
SHPT is a condition in which the parathyroid glands secrete excessive amounts of PTH into the blood due to renal and/or vitamin D insufficiency. Prolonged and excessive PTH secretion causes excessive calcium and phosphorus to be released from bone into the blood, leading to elevated serum calcium and phosphorus, various bone diseases and calcification of cardiovascular tissues.
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 specializes in developing new therapies which are designed to safely and effectively treat patients with stage 3, 4 and 5 CKD.