Nile Therapeutics Phase 2 Study Of CD-NP In Patients With Acute Decompensated Heart Failure Meets Primary Endpoint, Has Good Trends On Renal Function

Main Category: Heart Disease
Also Included In: Urology / Nephrology;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
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Nile Therapeutics, Inc. (Nasdaq: NLTX), a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, announced results of its Phase 2 study evaluating its lead compound CD-NP in patients with acute decompensated heart failure (ADHF) and mild to moderate renal insufficiency. Study results demonstrated that multiple doses were characterized as well tolerated with favorable drug activity in this acute patient population.

The open-label, single-blind, placebo-controlled Phase 2 study included 77 patients who were randomized into six cohorts at one of four doses of CD-NP (1.25, 2.5, 3.75 and 5 ng/kg/min) or placebo. Two cohorts were enrolled at each of the 1.25 and 2.5 ng/kg/min dose levels. Patients received study drug for up to 72 hours and were followed for 30 days. The primary objective of the study was to assess the safety and tolerability of CD-NP in a renally compromised ADHF population, the intended population of the therapy. Secondary endpoints included several assessments of drug activity.

CD-NP infusion at 1.25, 2.5 and 3.75 ng/kg/min appeared to be well tolerated. A dose-dependent effect on blood pressure was observed, with minimal or mild blood pressure reduction at 1.25 and 2.5 ng/kg/min, and moderate blood pressure reduction at 3.75 ng/kg/min. Dose escalation was limited by significant blood pressure reduction at 5 ng/kg/min.

Secondary and exploratory analyses demonstrated favorable effects of CD-NP on renal function, particularly at the 1.25 and 2.5 ng/kg/min doses. At these doses, CD-NP appeared to preserve or enhance renal function compared to placebo, as evidenced by favorable trends in several biomarkers correlated with kidney function, including creatinine and cystatin-c. Data will be presented at an upcoming cardiology conference.

"The data from this trial appear to indicate that we have identified active doses of CD-NP suitable for evaluation in a larger double-blind, placebo controlled study in acute heart failure patients," said James Young, MD, Professor and Dean of Medicine of the Cleveland Clinic and member of Nile Therapeutics Scientific Advisory Board. "Particularly interesting is CD-NP's apparent effect on kidney function, which would be a unique and clinically important benefit over the current standard of care."

"We are excited and encouraged by this data, particularly by the demonstration of activity in the intended patient population, supporting our belief that CD-NP has the potential to be a valuable new therapy for patients with cardiovascular and renal disease," said Joshua Kazam, Chief Executive Officer of Nile Therapeutics. "We look forward to the continued advancement of the CD-NP program."

About Heart Failure

Heart failure is the fastest-growing clinical cardiac disease in the U.S. according to the American Heart Association, affecting over 5 million Americans. Over 1 million patients in the U.S. each year are hospitalized with ADHF, an acute exacerbation of heart failure. This hospitalization rate is almost double the rate seen 15 years ago, and is the most frequent cause of hospital admission in the U.S. for patients older than 65 years, generating annual inpatient costs of more than $33 billion.

Safe Harbor Paragraph for Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding the timing, progress and anticipated results of the clinical development, regulatory processes, clinical trial and data analysis timelines, anticipated benefits of CD-NP, Nile's strategy, future operations, outlook, milestones, the timing and success of Nile's product development, future financial position, future financial results, plans and objectives of management are forward-looking statements. Nile may not actually achieve these plans, intentions or expectations and Nile cautions investors not to place undue reliance on Nile's forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Nile makes. Various important factors that could cause actual results or events to differ materially from the forward-looking statements that Nile makes include Nile's need to raise additional capital to fund its product development programs to completion, Nile's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in greater detail in the reports Nile files with Securities and Exchange Commission, including those described under the caption "Risk Factors" in Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2009 filed with the Securities and Exchange Commission on March 3, 2010. Nile is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

Source: Nile Therapeutics, Inc

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Geriatrician Advocates For Improvements To Primary Care To Meet The Needs Of Older Adults

Main Category: Primary Care / General Practice
Also Included In: Seniors / Aging;  Public Health
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In an article published in November 3 edition of Journal of the American Medical Association (JAMA), Chad Boult, MD, MPH, MBA, professor of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health, calls for key improvements to primary care in order to improve the health of the nation's most costly patients older adults with multiple chronic conditions. Boult and his co-author, G. Darryl Wieland, PhD, MPH, research director of Geriatrics Services at Palmetto Health Richland Hospital, Columbia, South Carolina, evaluated studies of new primary care models to determine the best way to improve care and outcomes for the more than 10 million older adults living with four or more chronic conditions.

"Today's primary care physicians are often overwhelmed by the complex needs of patients with multiple chronic health challenges, such as diabetes, high blood pressure, arthritis and more," said Boult. "Current medical training often does not prepare physicians to provide the comprehensive support that these patients require. Through our research, we identified four processes that can improve how we care for these patients, and three models that include these critical processes."

Boult and Wieland reviewed all peer-reviewed studies of comprehensive primary care models for older adults with multiple conditions published between 1999 and 2010. From this review, they identified four processes that are present in most successful models of primary care for these patients:

-- A comprehensive patient assessment that includes a complete review of all medical, psychosocial, lifestyle and values issues

-- Creation and implementation of an evidenced-based plan of care that addresses all of the patient's health-related needs

-- Communication and coordination with all who provide care for the patient, and

-- Promotion of the patient's (and their family caregiver's) engagement in their own health care.

"Most of today's primary care does not include these four processes, so patients receive fragmented and inefficient care that is further undermined by a lack of family and community support, " said Wieland, research director of Geriatrics Services at Palmetto Health Richland Hospital. "However, new models of primary care that include these processes have improved health outcomes, and patient and physician satisfaction, and have in some cases lowered the cost of care."

Boult and Wieland identified three models of care that have the greatest potential to improve effectiveness and efficiency of complex primary health care. All three models include a team-based approach to primary care, and they provide many of the same services to complex older patients, beginning with a comprehensive assessment and an evidence-based care plan. All of these models include proactive monitoring and coaching, coordination of care across all sites of care, support of patient's transitions from acute to post-acute settings, and access to community-based agencies.

-- GRACE (Geriatric Resources for Assessment and Care of Elders), a team-based intervention developed by researchers from Indiana University and the Regenstrief Institute. In a large clinical trial, GRACE improved the quality of care, decreased emergency department visits, and lowered hospital admission rates and costs in a group at high risk for hospital admission.

-- PACE (Program of All-inclusive Care for the Elderly), provides comprehensive, interdisciplinary team care to low-income frail elders. Based in an adult day health center, PACE professionals provide (or contract for) primary, specialty, emergency, hospital, home, and long-term care. PACE has been found to increase health screenings, reduce hospital admissions, increase nursing home stays, and reduce mortality among PACE participants at high risk of dying.

-- Guided Care, a multi-disciplinary model of comprehensive primary care for people with multiple chronic conditions, was developed by Johns Hopkins researchers. Early results from a multi-site, randomized controlled trial indicate that Guided Care improves the quality of patients' care, improves physician's satisfaction with some aspects of chronic care, and tends to reduce the use and cost of expensive health-related services.

Of the three models, only PACE is currently reimbursable through Medicare and state Medicaid programs.

"While most of the programs noted here are not yet widely available, we are hopeful that new initiatives launched by the Patient Protection and Affordable Care Act of 2010 will provide new opportunities for primary care physicians to care for their chronically ill patients more effectively and efficiently," said Boult. "More research is needed to define the optimal methods for identifying the patients who will benefit most, for providing the essential clinical processes, for disseminating and expanding the reach of these models, and for paying for excellent chronic care."

Source: Johns Hopkins Bloomberg School of Public Health

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