Symposium on Role of Vitamin D in Managing Chronic Kidney Disease Highlights Data From Hectorol(R) Study
ST. LOUIS, Oct. 29 /PRNewswire-FirstCall/ — Positive data from a Phase III study of Hectorol(R) for pre-dialysis (Stages 3 and 4) chronic kidney disease (CKD) patients was highlighted in a symposium today during Renal Week at the 37th Annual Meeting of the American Society of Nephrology. The symposium, entitled “Meeting the K/DOQI Mineral and Bone Guidelines in CKD (Stages 3 & 4): The Essential Role of Vitamin D,” included among its panel, Jill Lindberg, M.D. a lead investigator for the Hectorol(R) Phase III clinical trials and director of the Metabolic Bone and Stone Clinic, New Orleans Nephrology Associates, and associate clinical professor of medicine at Tulane University. Dr. Lindberg presented data that supports the rationale for treating secondary hyperparathyroidism (SHPT) in Stages 3 and 4 CKD. Her presentation included a Phase III study comparison between Rocaltrol(R) and Hectorol(R) related to safety and efficacy in Stages 3 and 4 CKD; the prevalence and incidence of renal osteodystrophy in early CKD and the role vitamin D plays in the prevention and amelioration; and how the use of vitamin D in early CKD can prevent hyperplasia of the parathyroid gland. Results from the Hectorol(R) study were previously reviewed at the National Kidney Foundation 2004 Clinical Meetings in Chicago on May 1, 2004, and published in the May 2004 issue of the American Journal of Kidney Disease.
Hectorol(R) Capsules
The safety and effectiveness of Hectorol(R) Capsules 0.5 mcg in pre- dialysis CKD patients were evaluated in two double-blind, placebo controlled trials. The trials consisted of an eight-week monitoring period in which no vitamin D hormone therapies were given, followed by a 24-week period in which patients were randomized to double-blind treatment with either Hectorol(R) Capsules 0.5 mcg or matching placebo. The study endpoint for effectiveness was the observed reduction in blood parathyroid hormone levels, and the endpoints for safety were the observed rates of hypercalcemia, hyperphosphatemia, hypercalciuria and significant decreases in kidney function. Analysis of pooled data from the two clinical studies demonstrated that parathyroid hormone (PTH) levels decreased from baseline by an average of 101.4 pg/ml (46%) vs. an average of 4.4 pg/ml (2%) in placebo treated patients (p<0.001). 74 percent of subjects achieved mean plasma PTH suppression of greater than or equal to 30 percent from baseline for the last four weeks of treatment; whereas only seven percent treated with placebo achieved this level of PTH suppression.
In terms of safety data, the incidences of hypercalcemia and hyperphosphatemia were similar to placebo therapy, no episodes of hypercalciuria were observed and there were no significant changes in renal function as compared to placebo treatment.
“The clinical data clearly shows that Hectorol(R) can effectively and safely manage SHPT in Stages 3 and 4 CKD patients,” stated Dr. Lindberg. “Hectorol(R) effectively lowers PTH while maintaining calcium and phosphorus within the K/DOQI target ranges. These are the key therapeutic results we are trying to achieve when treating this disease.”
In the injectable form, U.S. nephrologists use vitamin D2 hormone over older vitamin D3 therapies almost exclusively for dialysis. With the introduction of Hectorol(R) Capsules 0.5 mcg, the nephrology community now has the first oral vitamin D2 analog therapy available for use in pre-dialysis Stages 3 and 4 CKD.
Hectorol(R) is a unique pro-hormone formulation which is inactive upon administration. Therefore, it is not absorbed in the gastro-intestinal tract as active vitamin D but instead undergoes a more natural metabolic pathway as it is converted to its active form, primarily in the liver.
“Hectorol(R) has a unique pharmacokinetic (PK) profile that maintains active vitamin D levels within the normal physiologic range,” stated Jeffrey J. Freitag, M.D., Vice President of Research and Development at Bone Care International. “One of the key objectives of our research efforts is to further explore the potential benefits of Hectorol(R)’s unique PK profile.”
Secondary Hyperparathyroidism (SHPT)
SHPT initially develops in part due to the CKD patient’s inability to produce adequate levels of active vitamin D hormone. As CKD progresses, vitamin D hormone levels decline which can lead to SHPT. This disease is typically characterized by a subsequent decrease in calcium levels along with elevated levels of phosphorus and parathyroid hormone. If left untreated, SHPT may eventually result in (or aggravate underlying) cardiovascular disease, reduced immune system function, muscle weakness and bone mineral loss and fractures. K/DOQI guidelines point out that vitamin D hormone is useful in the treatment of secondary hyperparathyroidism and bone disease in early stages of CKD. It provides a good therapeutic tool for the prevention and management of these abnormalities in CKD patients, before these derangements advance and their treatment becomes more difficult.
Regarding Bone Care International
Bone Care International (http://www.bonecare.com/) is a specialty pharmaceutical company engaged in the discovery, development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Our current commercial and therapeutic focus is in nephrology, utilizing Hectorol(R), a novel vitamin D hormone therapy, to treat secondary hyperparathyroidism in patients with moderate to severe chronic kidney disease and end-stage renal disease. In addition to chronic kidney disease, the Company is developing vitamin D hormone therapies to treat hyperproliferative disorders such as cancer and psoriasis.
Contacts:
Rx Communications Group, LLC Bone Care International, Inc.
Melody A. Carey (Investors) Jeffrey J. Freitag, M.D.
(917) 322-2571 VP, Research & Development
Alison Minaglia (Media) (608) 662-7800
(917) 322-2566
Tony Ho Loke (Media)
917-322-2164
This press release contains forward-looking statements. Statements relating to future sales, costs of sales, other expenses, profitability, financial resources, or products and production schedules, or statements that predict or indicate future events and trends and which do not relate solely to historical matters identify forward-looking statements. Forward-looking statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on management’s current plans and expectations as well as assumptions made by and information currently available to management. Accordingly, the Company’s actual results may differ materially from those expressed or implied in such forward-looking statements due to known and unknown risks and uncertainties that exist in the Company’s operations and business environment, including, among other factors, the ability of the Company and each of its suppliers of doxercalciferol, Hectorol(R) Injection and Hectorol(R) Capsules to meet the Company’s anticipated production schedules, technical risks associated with the development of new products, regulatory policies in the United States and other countries, risks associated with our ability to avoid or minimize delays in/or interruption of the manufacture and supply of our products, including the approvals of regulatory authorities in connection therewith, reimbursement policies of public and private health care payors, introduction and acceptance of new drug therapies, competition from existing products and from new products or technologies, the failure by the Company to produce anticipated cost savings or improve productivity, the timing and magnitude of capital expenditures and acquisitions, economic and market conditions in the United States, Europe and the rest of the world, and other risks associated with the Company’s operations, including those identified from time to time in our public filings. The Company disclaims any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future events or developments.
Bone Care International
CONTACT: Melody A. Carey (Investors), +1-917-322-2571, or Alison Minaglia(Media), +1-917-322-2566, or Tony Ho Loke (Media), +1-917-322-2164, all of RxCommunications Group, LLC; or Jeffrey J. Freitag, M.D., VP, Research &Development of Bone Care International, Inc., +1-608-662-7800
Web site: http://www.bonecare.com/