KERX/AEZS - Notes on CC discussing Phase 2 Perifosine results
[Does anyone have any comments on the PR disclosing the actual results of this trial? The results look pretty good to me. I'm interested in any negative feedback on the results. I think AEZS is the more interesting play compared to KERX as it relates to Perifosine since they get high single to low double-digit royalties on sales of the drug, do not incur any of the expenses in development of the drug, and AEZS has a market cap that's about 1/3 of KERX's market cap.]
1. Majority of colon cancer patients in this trial were third line.
2. Baseline characteristics between Perifosine + Capecitabine arm and placebo + Capecitabine arm were almost identical.
3. Background info on treatment of metastatic colon cancer patients today:
A. 1st line setting - 80% of patients treated with FOLFOX (5-FU + oxaliplatin) regimen and remaining 20% treated with FOLFIRI (5-FU + irinotecan). About 70% of patients also receive treatment with Avastin. PFS is about 10-11 months for either FOLFOX or FOLFIRI + Avastin versus just about 8 months for FOLFOX or FOLFIRI alone. About 50% of patients taken off of oxaliplatin early in 1st line treatment due to side effects.
B. 2nd line setting - Primarily FOLFIRI plus/minus Avastin. EGFR inhibitors used here as well. PFS is about 4-5 months.
C. 3rd line setting - EGFR inhibitors used if not already used in prior setting and may be combined with irinotecan. PFS is about 2 months. About 40% of patients have KRAS mutation and don't respond to EGFR inhibitor.
4. KERX financing - company believes they have enough existing cash to conduct Phase 3 colon cancer trial for Perifosine. (As previously noted, AEZS licensed the drug to KERX, will receive high single to low double-digit royalties on sales, and doesn't incur any expenses with respect to the drug's development.) KERX says existing cash should last about two years, taking into account the colon cancer Phase 3 trial. KERX also indicated that they could receive an additional $15-20 million dollars between a milestone payment from Japan Tobacco for the Zerenex Phase 3 program, a separate milestone for another drug, and the exercise of options/warrants in the money. Such additional capital would give them about 3.5 years of cash.
AI
