New Vitamin D Prohormone and Phosphate Binder for Kidney Disease Patients
Replidea™ has been shown in a phase 2b clinical trial to effectively and
safely treat SHPT and the underlying vitamin D insufficiency in
pre-dialysis patients. Vitamin D insufficiency arises in CKD due to the
abnormal upregulation of
"OPKO intends to market Replidea™ along with our proprietary
point-of-care vitamin D diagnostic test currently in development,"
Alpharen™ has been shown safe and effective in treating
hyperphosphatemia in the phase 2 and 3 clinical trials undertaken to
date in dialysis patients. Hyperphosphatemia (elevated serum phosphorus)
exacerbates SHPT and promotes bone disease, soft tissue mineralization
and progression of kidney disease. Approximately 90% of dialysis
Cytochroma's officers, including
About Chronic Kidney Disease
CKD is a condition characterized by a progressive decline in kidney
function. The kidney is normally responsible for excreting waste and
excess water from the body, and for regulating various hormones. CKD is
classified in five different stages — mild (stage 1) to severe (stage 5)
disease — as measured by the kidney's glomerular filtration rate.
According to the
About Vitamin D Insufficiency
Vitamin D insufficiency is a condition in which blood levels of vitamin D prohormones, collectively known as 25-hydroxyvitamin D, are inadequate. An estimated 70-90% of CKD patients have vitamin D insufficiency which can lead to SHPT and its debilitating consequences.
About Secondary Hyperparathyroidism (SHPT)
SHPT is a condition commonly associated with CKD in which the parathyroid glands secrete excessive amounts of parathyroid hormone (PTH). SHPT arises as a result of vitamin D insufficiency or impaired kidney function. Prolonged elevation of blood PTH causes excessive calcium and phosphorus to be released from bone, leading to elevated serum calcium and phosphorus levels, softening of the bones (osteomalacia) and calcification of vascular and renal tissues. SHPT affects 40-60% of patients with stage 3 and 4 CKD and approximately 90% of patients with stage 5.
Hyperphosphatemia, or elevated serum phosphorus, is common in dialysis patients and tightly linked to the progression of SHPT. The kidneys provide the primary route of excretion for excess phosphorus absorbed from ingested food. As kidney function worsens, serum phosphorus levels increase and directly stimulate PTH secretion. Stage 5 CKD patients must reduce their dietary phosphate intake and usually require regular treatment with phosphate binding agents to lower serum phosphorus to meet the recommendations of the National Kidney Foundation's Clinical Practice Guidelines that serum phosphorus levels should be maintained at < 5.5 mg/dL.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies.
This press release contains "forward-looking statements," as that
term is defined under the Private Securities Litigation Reform Act of
1995 (PSLRA), which statements may be identified by words such as
"expects," "plans," "projects," "will," "may," "anticipates,"
"believes," "should," "intends," "estimates," and other words of similar
meaning, including statements regarding the benefits and synergies
resulting from the acquisition of Cytochroma, including whether the
Phase 3 clinical trials for Replidea™ and Alpharen™ may be
completed on a timely basis or at all, that earlier clinical results of
effectiveness and safety may not be reproducible or indicative of future
results, that any of Replidea™, Alpharen™ and/or any of our
compounds or diagnostics under development, including our point-of-care
vitamin D diagnostic test may fail, may not achieve the expected results
or effectiveness and may not generate data that would support the
approval or marketing of products for the indications being studied or
for other indications, that currently available over-the-counter and
prescription products, as well as products under development by others,
may prove to be as or more effective than Cytochroma's products for the
indications being studied, as well as other non-historical statements
about our expectations, beliefs or intentions regarding our business,
technologies and products, financial condition, strategies or prospects.
Many factors could cause our actual activities or results to differ
materially from the activities and results anticipated in
forward-looking statements. These factors include those described in our
filings with the
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