At the Piper Jaffray 21st Annual Health Care Conference being held in New York City, biotechnology company Keryx Biopharmaceuticals Inc. (KERX)'s Chief Executive Officer Ron Bentsur is scheduled to make a presentation on December 2nd.
The company has two product candidates - KRX-0401 (perifosine) and Zerenex (ferric citrate).
The potential oral anti-cancer agent Perifosine is pending commencement of phase III testing in relapsed and refractory multiple myeloma patients. In August, Keryx reached an agreement with the FDA under the Special Protocol Assessment, or SPA procedure on the design of the Perifosine trial. The late-stage trial will be a double-blind, placebo-controlled trial comparing the efficacy and safety of KRX-0401 vs. placebo when combined with Bortezomib and Dexamethasone.
According to the company, the trial will enroll approximately 400 patients with relapsed or relapsed / refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety.
Perifosine is in-licensed by Keryx from Aeterna Zentaris Inc. (AEZS) (AEZ.TO) in the United States, Canada and Mexico. The investigational drug is also under phase II clinical development for multiple tumor types.
The initial results of the combined phase I/II study of Perifosine in combination with Bortezomib with or without Dexamethasone in patients with relapsed/refractory multiple myeloma were revealed in February. The trial results demonstrated that Perifosine in combination with Bortezomib and Dexamethasone had an impressive response rate and time to progression in a heavily pre-treated patient population, with 83% of evaluable patients achieving stable disease or better. Patients on prior Bortezomib-based therapy and in whom the disease relapsed achieved an 8.5 month median time to progression in the study.
The updated data on progression free survival and overall survival of Perifosine in combination with Bortezomib and Dexamethasone will be presented at the upcoming 51st Annual Meeting of the American Society of Hematology, to be held in New Orleans from December 5-8.
The company's second product candidate Zerenex has completed a U.S. phase II clinical program as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease. The company is in the process of finalizing the U.S. phase III program for Zerenex in consultation with the FDA. Zerenex is also in phase II development in Japan by Keryx' Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.
For the third-quarter ended September 30, 2009, Keryx posted net income of $0.6 million or $0.01 per share, compared to a net loss of $6.8 million or $0.15 per share in the year-ago quarter. The profit recorded in the recent third quarter is attributed to the recognition of $3.5 million in other revenue, related to the settlement of a dispute with the former licensor of Sulonex, an investigational drug for diabetic nephropathy, in July 2009, over issues arising from the terminated license agreement and a decline in expenses.
Following a Drug Safety and Monitoring Committee review of a phase III study of Sulonex last March, Keryx terminated further development of the drug.
Keryx has yet to commercialize a drug candidate and currently generates revenue from licensing agreements or by providing clinical trial management and site recruitment services or by technology transfer, termination and settlement agreements related to its prior license agreements.
On September 30, 2009, Keryx completed a registered direct offering to certain institutional investors of 8 million shares of common stock and warrants to purchase up to a total of 2.8 million shares of common stock for gross proceeds of about $20 million.
At September 30, 2009, the company had cash, cash equivalents, interest receivable and investment securities of $41.0 million, compared to $22.7 million at December 31, 2008. That leaves the company with sufficient capital to complete the late-stage clinical programs for Perifosine and Zerenex.
KERX, which has thus far hit a 52-week low of $0.09 and 52-week high of $3.33 over the last twelve months, closed Monday's trade at $2.58.
With two product candidates pending commencement of late-stage trials, Keryx is a stock worth keeping an eye on.
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