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chemocentryx inc (CCXI) Key Developments

ChemoCentryx, Inc. Announces Positive Results in Phase II Diabetic Nephropathy Trial with CCR2 Inhibitor CCX140

ChemoCentryx, Inc. announced positive top-line 52-week data from its Phase II clinical trial in diabetic nephropathy with CCX140, an inhibitor of the chemokine receptor known as CCR2. The trial met its primary endpoint by demonstrating that treatment with 5 mg of CCX140 given orally once daily added to a standard of care regimen of angiotensin converting enzyme inhibitor or angiotensin receptor II blocker (ARB) treatment resulted in a statistically significant (p=0.0148) reduction in urinary albumin creatinine ratio (UACR), beyond that achieved with SOC alone. High UACR is known to predict poor renal outcome. The maximum treatment effect (24% reduction) was reached at 12 weeks, and sustained reduction in albuminuria induced by CCX140 relative to SOC alone was observed over the full year, i.e., UACR at each one of the 10 time points over the 52-week treatment period in the patients who received 5 mg CCX140 continuously for 52 weeks, were below those of the SOC alone group. A dose of 10 mg CCX140 per day did not provide more improvement in albuminuria as compared to the 5 mg dose. In addition, estimated glomerular filtration rate (eGFR) changes were assessed. Measuring eGFR is important in assessing long-term kidney function, and provides the basis for Phase III clinical trial registration endpoints. Numerous clinical trials with the current SOC show that these attenuate the slope of decline of eGFR, and that this translates into a beneficial effect on clinical outcome parameters such as time to dialysis, with chronic multi-year treatment. Treatment with CCX140 improved the eGFR profile. Initial analysis showed that after an acute effect in eGFR in the CCX140 treatment groups in the first 12 weeks, there was a sustained attenuation in the slope of annual decline in eGFR. Such eGFR profiles have been associated with successful long-term clinical benefit in kidney outcomes with approved diabetic nephropathy drugs. The treatment group receiving 5 mg of CCX140 in addition to SOC showed an attenuated annual slope decline of 1.3 mL/min/1.73 m2, compared to SOC alone group, 2.3 mL/min/1.73 m2. The magnitude of slope improvement seen for CCX140 is consistent with drugs that have been previously approved for diabetic nephropathy. CCX140 did not affect systemic blood pressure, suggesting that the beneficial effect of CCX140 is mediated locally in the kidney micro-environment, possibly through a beneficial reduction in renal inflammation. CCX140 appeared to be well tolerated with a low overall dropout rate over the 52-week treatment period. No safety issues were observed that would prevent further clinical development of CCX140 in diabetic nephropathy.

ChemoCentryx, Inc. - Special Call

To present top-line results from its Phase II trial with CCX140, an inhibitor of the chemokine receptor known as CCR2, in patients with diabetic nephropathy

ChemoCentryx, Inc. Announces U.S. Food and Drug Administration Has Granted Orphan-Drug Designation for CCX168

ChemoCentryx, Inc. reported that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for CCX168, an orally administered inhibitor targeting the receptor for the complement protein known as C5a (C5aR). The designation is for the treatment of atypical Hemolytic Uremic Syndrome (aHUS). Atypical hemolytic uremic syndrome is a rare, life-threatening, progressive disease, frequently with a genetic component, that primarily affects kidney function. ChemoCentryx has generated positive preclinical data that suggest an important role of C5a receptor inhibition in reducing micro vasculature thrombosis formation in aHUS. The Company plans to initiate a Phase II proof-of-concept study in patients with aHUS by the end of 2014. Orphan-Drug Designation by the FDA is granted to novel drugs that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven year period of U.S. marketing exclusivity upon marketing approval for the designated indication, as well as with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and the waiver of prescription drug user fees. Atypical hemolytic uremic syndrome, or aHUS, a life threatening disease that causes chronic blood vessel damage, thrombosis or clotting within blood vessels, hemolysis or red blood cell rupture, and sudden, progressive organ failure, such as kidney failure. The disease is caused by genetic defects in factors that control the activation of the complement system. Current treatment options are still quite limited and prognosis and quality of life are extremely poor.

ChemoCentryx, Inc. Reports Additional Data from Phase II Clinical Trial with Ccx168

ChemoCentryx, Inc. reported additional data from a Phase II clinical trial (the CLEAR trial) with CCX168, an inhibitor targeting the receptor for the complement protein known as C5a (C5aR), in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Improvement with CCX168 treatment in the non-renal manifestations of ANCA-associated vasculitis, in addition to the kidney aspect of this disease, is particularly intriguing, and highlights a potential broader role for a C5aR inhibitor such as CCX168 in treating AAV patients, not just with renal disease, but also with non-renal disease.

ChemoCentryx, Inc. Presents at Stifel Healthcare Conference 2014, Nov-19-2014 08:00 AM

ChemoCentryx, Inc. Presents at Stifel Healthcare Conference 2014, Nov-19-2014 08:00 AM. Venue: The Palace Hotel, 455 Madison Ave, New York, NY 10022, United States. Speakers: Susan M. Kanaya, Chief Financial Officer, Principal Accounting Officer, Senior Vice President of Finance and Secretary, Thomas J. Schall, Founder, Chairman, Chief Executive Officer and President.

 

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