Navigation Links
Cytochroma Reports Positive Phase I Clinical Data for CTA018,Injection

MARKHAM, ON, June 28, 2007 /PRNewswire/ - Cytochroma Inc. announced today positive data from a Phase I clinical trial of CTA018 Injection. The initial top-line results from this trial showed that CTA018 was safe and well tolerated. Complete study results are expected in August 2007.

The recently completed Phase I trial was an open label, placebo-controlled, randomized study of CTA018 Injection administered to 20 healthy volunteers. In this trial, the safety of CTA018 Injection was evaluated after single doses of up to 180 mcg. Placebo and two strengths of CTA018, 90 mcg and 180 mcg, were subsequently studied during repeated dose administration. The trial was conducted at a single Canadian center. Key safety evaluations included adverse events, serum and urine calcium, serum ionized calcium and serum phosphorus. No drug-related adverse events were reported.

Significant reduction in the blood levels of parathyroid hormone (PTH) was observed in this trial, suggesting that CTA018 has potential as a treatment for secondary hyperparathyroidism in chronic kidney disease (CKD). Blood samples collected before and after repeated CTA018 administration documented a mean reduction in PTH level of more than 20% after five doses of 180 mcg.

"While this safety trial was not designed to demonstrate efficacy, we were pleasantly surprised to see a significant reduction of PTH levels after just a few doses of CTA018," stated Dr. Jukka Karjalainen, Executive Director, Product Development. "As expected, we did not see any elevations in serum or urine calcium or in serum phosphorus. Serum ionized calcium levels also remained unchanged. We believe that the PTH-lowering effect of CTA018 will be even more pronounced in CKD patients with secondary hyperparathyroidism."

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 both a strong activator of the Vitamin D signaling pathway and a potent inhibitor of CYP24, the intracellular enzyme responsible for normal catabolism of Vitamin D hormones. Based on its mechanism of action, CTA018 is expected to be effective in treating secondary hyperparathyroidism but safer 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 Inc. from the Johns Hopkins University.

About Chronic Kidney Disease and Secondary Hyperparathyroidism

Vitamin D hormones and their analogues are currently used to treat secondary hyperparathyroidism in CKD and end-stage renal disease. According to the National Kidney Foundation, more than nine million North American patients suffer from moderate to severe CKD. Many develop Vitamin D insufficiency and secondary hyperparathyroidism which, if untreated, can cause debilitating bone diseases and increased patient morbidity and mortality. North American sales of Vitamin D therapies for the treatment of secondary hyperparathyroidism currently exceed $500 million per year and are expected to grow rapidly with the increasing incidence of CKD. CKD is most frequently caused by diabetes or hypertension, both of which are consequences of the widening North American epidemic of obesity.

About Cytochroma Inc.

Cytochroma (www.cytochroma.com) is a specialty pharmaceutical company engaged in the development and commercialization of proprietary products to treat and prevent the clinical consequences of Vitamin D insufficiency. The Company has an advanced portfolio of new therapies for Vitamin D insufficiency and secondary hyperparathyroidism associated with CKD. In addition, the Company is developing novel therapies to treat hyperproliferative disorders, such as cancer and psoriasis, and hyperphosp hatemia

CONTACT: Eric J. Messner, Vice President, Commercial Operations, (905)479-5306 ext. 338, eric.messner@cytochroma.com

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
2. Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis
3. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
4. Cytos Biotechnology Reports Results from Phase IIa Study with CYT003-QbG10 in Patients Suffering from Atopic Dermatitis
5. Cytokinetics Reports Additional Clinical Trials Data for Ispinesib
6. The European Myeloma Platform Reports New Survival data for Revlimid Presented at the International Myeloma Workshop in Greece
7. Speedel Reports Successful SPP635 Phase IIa Trial in Hypertension
8. Columbia Laboratories Reports Positive Results from Multi-dose Pharmacokinetic Study of Vaginally-administered Lidocaine
9. CytRx Reports Promising Data from Its Open-Label Extension Clinical Trial of Arimoclomol in ALS
10. Affymax Reports Phase 2 Clinical Dose Ranging Results of Once-Per-Month Hematide for the Treatment of Anemia
11. Bentley Reports Positive Results with Nasulin Intranasal Insulin Spray at the American Diabetes Association Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... 2016 Orthopedic Implants (Including Spinal Implants, ... to Gain a Significant Market Share Owing to a Large ... ... According to a new report by Persistence ... Packaging: Clamshell Product Type Segment Projected to Witness a Significantly ...
(Date:12/2/2016)... MONMOUTH JUNCTION, N.J. , Dec. 2, 2016 /PRNewswire/ ... critical care immunotherapy leader commercializing its European Union approved ... in critically-ill and cardiac surgery patients worldwide, announced that ... present at the 9th Annual LD Micro Main ... 8 th , 2016 at the Luxe Sunset Boulevard ...
(Date:12/2/2016)... NEW YORK , December 2, 2016 ... at 5,251.11, down 1.36%; the Dow Jones Industrial Average edged ... closed at 2,191.08, down 0.35%. Losses were broad based as ... Today, Stock-Callers.com has initiated research reports on the following Services ... N.V. (NASDAQ: QGEN ), INC Research Holdings Inc. ...
Breaking Medicine Technology:
(Date:12/2/2016)... ... December 02, 2016 , ... Yisrayl Hawkins, at The House of Yahweh ... generation fits into Bible Prophecy. Yisrayl says this generation, known as the Last Generation, ... showing how the details line up exactly with Bible Prophecy – a protected way ...
(Date:12/2/2016)... ... December 02, 2016 , ... Clarify Health ... has raised $6.0 million in an initial round of funding. The round was ... and their caregivers can receive far better care through the application of the ...
(Date:12/2/2016)... ... December 02, 2016 , ... Today CloudMine, a secure, ... was named the best Sales Team of 2016 as part of the 2016 ... by the Software & Information Industry Association (SIIA), the principal trade association for ...
(Date:12/2/2016)... FL (PRWEB) , ... December 02, 2016 , ... ‘Tis ... are winners of $1,000 each from the National Family Partnership and the Drug Enforcement ... families who decorated their homes and the 10 winning schools who decorated their campuses ...
(Date:11/30/2016)... , ... November 30, 2016 , ... ... they now offer a comprehensive in-house dental plan for all patients. Understanding that ... a plan that gives patients a number of perks, including discounts on many ...
Breaking Medicine News(10 mins):