Wisconsin Alumni Research Foundation: Deltanoid’s DP001 (2MD) pharmaceutical demonstrated safe and effective in kidney failure patients on dialysis

DP001 successfully meets primary and secondary endpoints in
greater than 80 percent of patients

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.

About Deltanoid

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(R), Calcijex(R), Hectorol(R),
Zemplar(R), One-Alfa(R) and Alfarol(R).

About WARF

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.