Introgen Therapeutics (INGN - Get Report) on Sunday presented new clinical data on its gene therapy drug Advexin. Unfortunately, the new information does little to rehabilitate Introgen's reputation as one of the biotech sector's worst dissemblers.I've made no secret of my low opinion of Introgen, its drug Advexin or management, which I believe have bamboozled investors for years. Fortunately, the tricks and spin aren't working as well as they used to for CEO David Nance and his Austin, Texas, gang. In the few days since the Sunday release of the new Advexin data, Introgen shares are off roughly 8%. Sensible investors have long ago written off Introgen (except short-sellers, for obvious reasons). But the company is still worth covering because there's a teaching moment with almost every press release. Introgen is like a living textbook for what investors need to be wary of when considering a biotech investment. At a cancer conference in San Diego on Sunday, Introgen presented what it claims was positive interim data from a phase III study of Advexin treating patients with cancer of the head and neck. The company says the new data confirms the efficacy of Advexin -- including a survival benefit for these patients -- seen in a previous phase II study. Introgen says it will use this data to seek approval for Advexin in the U.S. and Europe later this quarter. To download a PDF version of poster of the new Advexin data, click here or here. Don't rely on company-issued press releases. Go directly to the data source. If a poster is not publicly available, call up the company and ask for it. If they say no, ask yourself what they're hiding. Let's go through the Advexin poster to highlight its multiple red flags. This is stuff that is broadly applicable. If you can spot red flags in clinical data presentations, you can avoid getting suckered into biotech money traps. There are plenty of good biotech companies focused on cancer drugs for investors to consider. Genentech and Celgene ( CELG - Get Report) top the list, of course, but there's also ImClone Systems ( IMCL), Onyx Pharmaceuticals ( ONXX) and OSI Pharmaceuticals . One reason these companies are tops is because you won't find them taking shortcuts with clinical research. But never assume anything, especially when doing due diligence on developmental-stage cancer companies like Exelixis ( EXEL - Get Report), Arqule ( ARQL), Cougar Biotechnology and Synta Pharmaceuticals ( SNTA), to name a handful. Use the tips below in your due diligence and you'll be a savvier biotech investor.
There are a lot of missing patients in Introgen's Advexin poster. The phase III study enrolled 123 patients; 63 patients treated with Advexin, according to the poster. That means there were 60 patients treated with the drug methotrexate in the study's control arm. Yet the analyses, including survival and response rate, were conducted using only 38 Advexin patients and 29 methotrexate patients. That means 40% and 48% of patients treated with Advexin and methotrexate, respectively, are missing. Where are the rest of the patients and why weren't they included in the analyses? Incomplete data are unreliable data and usually tell you that the company is hiding something.