Tuesday October 25, 2011
by John McCamant, editor The Medical Technology Stock Letter
OncoGenex Pharmaceuticals (OGXI) represents an excellent long-term investment for patient investors.
The company has advanced their pipeline, announcing the start of patient enrollment in a randomized, Phase II clinical trial testing OGX-427, an inhibitor of heat shock protein 27 (Hsp27), in patients with advanced bladder cancer.
The trial is designed to assess the potential survival benefit of combining ‘427 with standard first-line chemotherapy, as well as its safety, tolerability and optimal dosing regimen.
Hsp27, which is over-expressed in many cancers, helps tumor cells survive by resisting the effects of anti-cancer treatments, such as chemotherapy and radiation therapy.
This international Phase II trial is a double-blind, placebo-controlled, 3-arm, randomized trial that will enroll approximately 180 patients with advanced bladder cancer who have not previously received chemotherapy for metastatic disease and are not candidates for potentially curative surgery or radiotherapy.
Patients will be randomized to receive gemcitabine, cisplatin, and OGX-427 at two dose-levels (600 mg and 1000 mg) vs. gemcitabine, cisplatin, and placebo.
The study will be conducted at approximately 45 cancer centers throughout North America and Europe.
In addition, ‘427 is currently being studied in an investigator-sponsored, Phase I trial of patients with superficial bladder cancer and an investigator-sponsored, randomized, Phase II trial of men with castrate-resistant prostate cancer who have not received chemotherapy for metastatic disease.
Preliminary data from these two trials are expected to be presented in early 2012. Previous phase I data for ‘427 showed encouraging signs of efficacy in patients with breast, prostate, bladder, ovarian and non-small cell lung cancer. That data was presented at the 2010 ASCO.
This Phase I data showed anti-cancer activity, safety, and tolerability with ‘427 as a single agent and in combination with chemotherapy.
We are pleased to see ‘427 progress into an additional Phase II trial as Phase II is often where cancer drug development candidates can really show their potential and add market value to the companies developing them.
OGXI has now clearly established a second drug development candidate in its pipeline despite there being no real value currently reflected it its market cap.
We are not sure when OGXI will begin to be discovered by Wall Street, but in our opinion, the company is clearly undervalued (market cap less than $100 million). OGXI is a buy.
Learn more about this financial newsletter at John McCamant's The Medical technology Stock Letter.