|
|
 | | | |
- close
- close
- close
- close
Keryx Biopharmaceuticals (KERX) |
Suggest other news sources for this topic
WIKI ANALYSIS
Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing perifosine, a novel, potentially first-in-class, oral anti-cancer agent that inhibits key signal transduction pathways, which are associated with programmed cell death, cell growth, cell differentiation and cell survival. Perifosine is currently in Phase III clinical development for both refractory advanced colorectal cancer and multiple myeloma.
Each of the Phase III programs is being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase III clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA.
ZERENEX (ferric citrate) (an iron-based phosphate binder to treat elevated phosphorus blood levels in dialysis patients)
Initiated short-term efficacy study 5/6/10 with top-line results expected in DEC 2010, long-term safety plus efficacy study (58-week study in approx. 300 patients) expected to begin in SEP or OCT 2010 with data anticipated during 1H12, Japan Partner (JT Torii) Phase 3 pivotal study expected to begin by year-end 2010 (milestone payment due to KERX once started)
Perifosine (KRX-0401)
Pivotal Phase 3 Clinical Trials under SPA
Refractory metastatic colorectal cancer (mCRC) study initiated 4/8/10, patient enrollment (430 patients) expected to conclude in 12-14 months, study completion and top-line results projected during 2H11, North American rights to perifosine in-licensed from Aeterna Zentaris (AEZS), announced Fast Track designation by FDA for mCRC on 4/5/10
Relapsed or relapsed / refractory multiple myeloma (MM) patient study began Dec. 2009, patient recruitment (400 patients) expected to conclude in 16-18 months, study completion and top-line results projected during 1H12, FDA Orphan Drug / Fast Track status, North American rights to perifosine in-licensed from Aeterna Zentaris (AEZS)
| |||||||
