MADISON, Wis., Oct. 15, 2014 (GLOBE NEWSWIRE) -- Deltanoid Pharmaceuticals announces the successful completion of a phase 2B clinical trial for its lead experimental drug DP001 for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease receiving hemodialysis.
"We believe DP001 is the most potent active vitamin D available," says Hector DeLuca, CEO of Deltanoid and a pioneer in the field. "It is safer, works longer and may eliminate the need for costly calcimimetic therapy."
The results of the trial will be presented at the American Society of Nephrology meeting this November in Philadelphia. Deltanoid has an exclusive license to DP001 from the Wisconsin Alumni Research Foundation.
In a 12-week double-blind, randomized, placebo-controlled study, 62 patients received DP001 or placebo three times per week at the completion of a dialysis session. Results show that an overall 46 percent reduction in parathyroid hormone (PTH) from baseline was achieved in DP001-treated subjects, whereas there was an increase in PTH of 31 percent in the placebo group.
Patients who had been managed on other commercially available active vitamin D (AVD) combined with calcimimetic therapy prior to entering the clinical trial were equally well managed on DP001 as the sole therapy. Thus, DP001 effectively eliminated the need for adjunctive calcimimetic therapy in the majority of hemodialysis patients previously requiring both treatments.
"One of the unique properties of this new drug is its selectivity for the parathyroid gland," says DeLuca. "That means less adverse side effects in other tissues."
DP001 was safe at all doses administered in the study, and no DP001-treated patients exceeded the safety threshold for albumin-corrected serum calcium. More adverse events were reported in the placebo than the DP001 group, and none of the serious adverse events reported during the trial were deemed DP001-treatment related.
Moreover, previous testing in an animal model of renal failure showed that DP001 has a wider therapeutic window and continued to suppress PTH as the disease progressed, while a leading commercially available AVD did not.
Deltanoid is expecting to file a new drug application in the next two years.
Deltanoid is a small biopharmaceutical company based in Madison, Wisconsin, devoted to the development of early university-based inventions into commercial products with special emphasis on vitamin D-based pharmaceuticals. For more information, visit deltanoid.com.
Dr. Hector F. DeLuca, CEO of Deltanoid, has been responsible for most of the currently used active vitamin D compounds in this and other applications, including Rocaltrol®, Calcijex®, Hectorol®, Zemplar®, One-Alfa® and Alfarol®.
The Wisconsin Alumni Research Foundation (WARF) helps steward the cycle of research, discovery, commercialization and investment for the University of Wisconsin–Madison. Founded in 1925 by Professor Harry Steenbock (Hector DeLuca's mentor) as an independent, nonprofit foundation, WARF manages more than 1,600 active patents and an endowment of $2.6 billion as it funds university research, obtains patents for campus discoveries and licenses inventions to industry. For more information, visit warf.org.
About secondary hyperparathyroidism (SHPT)
SHPT is a common and serious condition that affects many of the millions of dialysis patients throughout the world. The disorder develops in response to chronic kidney failure. With a loss of kidney function, there is a failure to convert vitamin D to its active form, 1α,25-dihydroxyvitamin D3. As a result, calcium is not absorbed or mobilized, resulting in chronically low serum calcium. The parathyroids (four small glands in the neck) are the sensors of serum calcium and secrete parathyroid hormone to mobilize calcium in response to the low levels. This can result in SHPT leading to bone deterioration. Active 1α-hydroxylated vitamin D compounds act directly on the parathyroids to suppress parathyroid hormone synthesis and secretion.
Nephrologists treat SHPT by administering active 1α-hydroxylated vitamin D compounds. In difficult to manage patients, a calcimimetic that reduces the impact of low blood calcium on parathyroid secretion is also administered. The currently used therapies in the U.S. are calcitriol, Hectorol®, Zemplar® and Sensipar®. In addition, maxacalcitol and Alfarol® also are in use in Japan.
Deltanoid Pharmaceuticals, Inc., Madison, Wis. Hector F. DeLuca, 608-262-1620