MARKHAM, ON, April 3, 2012 /PRNewswire/ - Cytochroma today announced that the
United States Patent and Trademark Office (USPTO) issued a Notice of
Allowance for US Patent Application # 13/244,945. 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 3
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 2b study which ended in late 2011. The positive
results obtained in the Phase 2b 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."
About CTAP101 Capsules
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.
About Chronic Kidney Disease
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. According to the National Kidney Foundation, CKD
afflicts over 26 million people in the US, including more than eight
million patients with moderate (stages 3 and 4) CKD. In stage 5 CKD,
kidney function is minimal to absent and patients require regular
dialysis or a kidney transplant for survival.
About Secondary Hyperparathyroidism (SHPT)
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. SHPT affects 40-60% of
patients with moderate CKD and approximately 90% of patients with
severe CKD.
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 specializes in developing new
therapies which are designed to safely and effectively treat patients
with stage 3, 4 and 5 CKD. Cytochroma also has a portfolio CYP24 and
phosphate-uptake inhibitors in early stage development.
For more information about Cytochroma, please visit www.cytochroma.com.
SOURCE Cytochroma