|Keryx / Aeterna Drug Shows Promise in Late-Stage Colon Cancer Patients|
|Wednesday, 27 January 2010 09:34|
The ProActive News Room website for Keryx Biopharma (NASDAQ: KERX) has been updated to include the Company's most recent corporate presentation and the GI-ASCO 2010 poster presentation from last weekend. In the randomized Phase 2 trial, perifosine + capecitabine (P-CAP) demonstrated a statistically significant improvement in TTP (time to progression) and OS (overall survival) compared to placebo + capecitabine (CAP) in patients with second or third-line mCRC (metastatic colorectal cancer). ORR (overall response rate) was also improved for P-CAP over CAP.
Perifosine is in-licensed by KERX from Aeterna Zentaris (NASDAQ: AEZS). During 2010, KERX expects to report updated data from its Phase 2 colon cancer study, conduct / update additional earlier stage Phase I/II studies, finalize late-stage trial protocol for colon cancer study, and begin a late-stage study for colon cancer patients in addition to the ongoing pivotal Phase 3 study for multiple myeloma under a Special Protocol Assessment (SPA) with the FDA. KERX is preparing to begin a pivotal Phase 3 trial of perifosine in patients with mCRC and an additional SPA with the FDA for this indication is expected within the next three months.
Below are some highlights from the GI-ASCO poster presentation:
1.) The improvements in TTP and OS with P-CAP compared to CAP are also seen in patients with 5-FU refractory disease. One patient with 5-FU refractory disease had a PR on P-CAP.
2.) P-CAP was well tolerated compared to CAP alone.
3.) A Phase I study to evaluate the combination of perifosine + capecitabine using a higher dose of capecitabine at 1000 mg/m2PO BID days 1 -14 is underway. PK of perifosine and capecitabine are being examined.
4.) Given the improved clinical efficacy of P-CAP compared to CAP in 5-FU refractory patients, a randomized Phase III study comparing P-CAP to CAP in patients with refractory mCRC is planned.
Below is a summary of additional expected catalysts and milestones for KERX:
On 12/16/09, KERX announced the initiation of a Phase 3 pivotal study of perifosine (KRX-0401), the Company's PI3K/Akt pathway inhibitor, in multiple myeloma patients. It is structured as a double-blind, placebo-controlled trial comparing the efficacy and safety of perifosine vs. placebo when combined with bortezomib (Velcade) and dexamethasone and will enroll 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. Approximately 265 events (defined as disease progression or death) will trigger the un-blinding of the data. KERX expects a patient recruitment period of approximately 16-18 months and expects to report data from this study during 2H11.
On 1/5/10, KERX announced that it has reached agreement with the FDA regarding a SPA on the design of a Phase 3 clinical program for Zerenex (ferric citrate), its iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD). In accordance with the Company's SPA agreement with the FDA, the Phase 3 clinical program for Zerenex will consist of two clinical studies, including (1) a short-term efficacy study that is expected to commence by the end of 1Q10 with date expected during 2H10; and (2) a long-term safety and efficacy study that is expected to begin mid-2010 with data expected and a NDA filing expected during 1H12.
KERX also has a partnership in Japan with JT Torii that includes over $100 million in potential milestone payments. The ongoing Phase 2 study in Japan is near completion and KERX expects the Phase 3 trial to begin during 2H10, which will trigger a development milestone payment that is in the mid single digit million dollar range. An additional $15 million milestone is possible upon regulatory approval in Japan, with approximately $55 million in remaining milestone payments based on the achievement of sales targets upon commercialization.
Disclosure: Long KERX