Keryx Biopharmaceuticals Inc fka KERX

[califax]

Keryx Biopharma's Colorectal Cancer Drug Granted Fast Track Designation By FDA; Shares Up - Update

4/5/2010 12:40 PM ET
http://www.rttnews.com/ArticleView.aspx?Id=1260318

(RTTNews) - Keryx Biopharmaceuticals, Inc. (KERX) said Monday that the U.S. Food and Drug Administration or FDA granted Fast Track designation for perifosine for the treatment of refractory advanced colorectal cancer. Keryx shares reached as high as 41% in the pre market session, and is currently up over 28%.

New York-based Keryx is a partner of Aeterna Zentaris (AEZS, AES.TO) and holds the license for perifosine in US, Canada and Mexico. Perifosine is also out-licensed to Handok in South Korea while Aeterna retains rights for the rest of the world.

The Fast Track designation from FDA facilitates development and expedition of the review of new drugs that are intended to treat serious or life-threatening conditions. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.

According to the American Cancer Society, colorectal cancer is the third most common form of cancer diagnosed in the United States, with nearly 146,000 people diagnosed with some form of colorectal cancer and over 49,000 patients dying from colorectal cancer in 2009. Treatment of patients with recurrent or advanced colorectal cancer depends on the location of the disease.

KRX-0401 or perifosine is a potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase or PI3K pathway, for the treatment of refractory advanced colorectal cancer. KRX-0401 demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies.

Keryx informed that a randomized, double-blind Phase III trial investigating perifosine in combination with capecitabine, or Xeloda versus placebo plus capecitabine in patients with refractory advanced colorectal cancer, to be initiated in the second quarter, with study completion expected in the second half of 2011. The company expects commercialization of perifosine in current indication to potentially commence by mid-2012.

The phase III study is under a Special Protocol Assessment, or SPA, with the FDA. Xeloda is owned by Swiss drugmaker Roche Holding AG (RHHBY.PK: News ). Last week, the EMEA approved cancer drug Xeloda for treating patients with early colon cancer.

Juergen Engel, president and chief executive officer of Aeterna said, "We now look forward to the initiation and sponsorship by our partner, Keryx, of this key registration Phase 3 trial in refractory metastatic colorectal cancer in North America which they expect to complete in 2011, with product launch, in the USA, in 2012. These data will be very supportive of our efforts to register perifosine in the rest of the world, and in some countries, we expect they will be sufficient to do so without any additional studies."

In addition to colorectal cancer, perifosine is currently in a Phase III trial, under SPA, for the treatment of relapsed or refractory multiple myeloma, with Orphan Drug Status and Fast Track designation granted by the FDA.

Earlier, Aeterna Zentaris informed that it received a positive opinion for Orphan Medicinal Product Designation for perifosine from the Committee for Orphan Medicinal Products, or COMP, of the European Medicines Agency for the treatment of multiple myeloma.

Currently, there are seven approved drugs for patients with metastatic/advanced colorectal cancer: 5-fluorouracil (5-FU), capecitabine (Xeloda), irinotecan (Camptosar), oxaliplatin (Eloxatin), bevacizumab (Avastin), cetuximab (Erbitux), and panitumumab (Vectibix).

Keryx also develops Zerenex to treat elevated phosphate levels or hyperphosphatemia, in patients with end-stage renal disease. The Phase III clinical program of Zerenex is pending commencement under an SPA agreement with the FDA.

by RTT Staff Writer