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Keryx Biopharmaceuticals (NASDAQ: KERX) responds to erroneous report about planned Phase III study for patients with Colorectal Cancer

Written by Mike Havrilla
Friday, 05 February 2010 12:37
http://biomedreports.com/articles/most-popular/27884-keryx-biopharmaceuticals-nasdaq-kerx-responds-to-erroneous-report-about-planned-phase-iii-study-for-patients-with-colorectal-cancer.html

Keryx Biopharmaceuticals (NASDAQ: KERX) was mentioned in a published article which contained an inaccurate statement regarding the design of a pending Phase III study for patients with metastatic colorectal cancer (mCRC) that is summarized in quotes below.

". . . The only point of concern I see is that the phase III study will enroll patients who failed treatment with either Erbitux or Vectibix, which makes them a bit sicker than half the patients in the phase II study who were never treated with either commonly-used colon cancer drug. . ."

BioMedReports reached out to Keryx for their comment on the concern noted in the TheStreet.com article today and spoke with the Keryx CEO, Ron Bentsur. Mr. Bentsur noted it is estimated that approximately 50% to 60% of mCRC patients are KRAS positive, so that only this sub-group would potentially benefit from receiving an EGFR antibody such as Erbitux or Vectibix, while the remaining 40% to 50% of mCRC patients do not receive EGFR inhibitors.

Based on these statistics, Keryx estimates that only 50% to 60% of the patients to be enrolled in its upcoming Phase 3 trial for perifosine in metastatic colorectal cancer will have received and failed treatment by either Erbitux or Vectibix, which is similar to the patient population in the Keryx Phase 2 study, as well as the general population.

In addition, the data reported in the Keryx Phase 2 study for the sub-set of 5-FU refractory patients indicated that 60% of those patients had failed prior EGFR antibody, underscoring the fact that the Phase 2 population mimics the targeted Phase 3 patient population, and both of the studies represent true snapshots of the general patient population. In summary, the pending Phase 3 study and the Phase 2 study populations will be virtually the same.

On 2/3/10, Keryx announced that it had reached agreement with the FDA regarding a SPA on the design of a Phase 3 trial for perifosine in patients with refractory mCRC. The Phase 3 X-PECT trial will be a randomized, double-blind trial comparing the efficacy and safety of perifosine + capecitabine (capecitabine is a chemotherapy marketed by Roche as Xeloda) vs. placebo + capecitabine in approximately 430 patients with refractory metastatic colorectal cancer. The primary endpoint is overall survival (OS), with secondary endpoints including overall response rate (ORR: complete responses + partial responses), progression-free survival (PFS) and safety.

The median OS for the X-PECT study's targeted patient population, that has failed prior therapies as described above, is approximately 5 months. The X-PECT study will be powered at 90% to detect a statistically significant difference in OS, with an assumed median OS for the control arm of 5-6 months and 7-8 months for the perifosine arm. Approximately 360 events of death will trigger the un-blinding of the study. Approximately 40-50 U.S. sites will participate in the study, which is expected to begin during 2Q10 while enrollment is expected to take approximately 12 months, with study completion expected in 2H11.