CLPA Conference Call TODAY
CLPA Conference call 4:15 today 1-800-260-0719. Replay number 1-800-475-6701 code 474044
And if that doesn't wake you up, here is a recent CLPA rebuttal to a somewhat negative article in the Philly News:
phillynews.com
Cell Pathways article and cancer-fighting drug
The article "After 10 years, Cell Pathways still lacks cancer-fighting drug" (Inquirer, Oct. 19) was unbalanced and poorly researched. Its lack of balance starts with the headline. As explained below, we believe exisulind is effective.
But as for "10 years," your headline inaccurately suggests that Cell Pathways should have had a drug approved by now. Drug development can commonly take 10 to 15 years. By contrast, Cell Pathways has brought exisulind to the FDA for approval in well under nine years. Cell Pathways has been able to proceed to the point of a New Drug Application filing with the FDA after spending, in total, less than $60 million. Industry averages are at least several times that amount. Cell Pathways' accomplishment is all the more remarkable for a drug like exisulind that operates mechanistically in a different way from drugs that came before.
As for efficacy, your omissions are numerous. You ignored the fact that the very colon polyp study your article relies upon for its misplaced opinion about supposed lack of efficacy demonstrated a 50 percent reduction in colon polyp formation in the drug-treated patients eligible for the study. Your article also ignores the earlier study conducted at the Cleveland Clinic on exisulind. Started in 1995, this continuing study has been demonstrating both safety and beneficial disease management (through polyp suppression) ever since.
Equally glaring, your article omits any mention of the clinical trial of exisulind for prostate cancer patients post-prostatectomy with rising PSAs (indicating that prostate cancer has recurred), conducted at Columbia University and other leading centers. In the drug-treated patients on average, exisulind caused the PSA levels to stabilize (as compared with the placebo group whose PSA levels continued to rise on average) according to an analysis performed by an independent party after all patients had completed six months in the study.
Your article also fails to reference any one of at least 25 peer-reviewed journal articles and abstracts where exisulind has been shown to have activity in cell line and animal models of human cancers including melanoma, breast, cervical, colon, prostate, and lung. This wide range of activity is newsworthy at least to editors, peer reviewers and readers of such journals.
Equally significant is your article's omission of a major benefit of exisulind: its safety. In contrast to patients taking conventional chemotherapeutic drugs, patients on exisulind have taken the drug every day for years without the clinically significant side effects normally associated with chemotherapeutic drugs. We believe this safety is directly due to the novel way the drug works mechanistically.
In short, the first major article in The Inquirer devoted to exisulind - a drug that many others believe holds very substantial promise - misses and distorts the story. By contrast, the cancer research community has been so interested in this small company in The Inquirer's backyard that more than 25 major universities and cancer centers have entered into agreements with us to study our drugs.
The primary sources for your article appear to be Jim McCamant (a stock analyst, who according to your article admittedly had not completed his research into Cell Pathways) and one press release from the company reporting our preliminary analysis of one of our colon polyp studies. As your article indicated, we accepted McCamant's invitation for a meeting - a meeting scheduled well before your article was published. McCamant told us he was shocked to hear he was quoted by The Inquirer and, after we explained what we have been doing, said that we were doing all the right things.
As for your recitation of McCamant's alleged criticism about the company not keeping our stockholders advised, he indicated to us that he was speaking about biotech companies generally, not necessarily about us. He said he had been withholding judgment about us. As for the press release you rely on, McCamant agreed that it would be difficult to communicate the full story about its subject in a press release, and was pleased to learn we had an investor conference call on that subject immediately following that release, particularly since the call was available to our shareholders for replay for three days afterward via a toll-free number. We are unaware of any other public company that would be more open about its affairs under such circumstances.
While McCamant may be excused for not having completed his research (which he admitted), The Inquirer should not. The Inquirer was able to interview McCamant in California. Cell Pathways is a local call and a short distance away in Horsham. While one of our officers did receive a late Friday phone message from The Inquirer purportedly to discuss our "recent financing" announced a week earlier, he was out of town on other matters. A more patient and determined reporter could have waited for a return call, called again or called someone else. We were not informed of any date of publication from that phone message, nor should there have been any rush to publish since most of the information in the article was months old.
Your reporter also could have done more independent research before publishing an article with deficiencies evident from information publicly available elsewhere. A visit to and careful reading of our Web site, www.cellpathways.com, would have provided some of the basic information above.
In fairness to the readers of The Inquirer, you could and should have done a much better job with the information available.
We agree with one un-newsworthy point in the article: The pharmaceutical business is risky. One of the risks that a small company like ours should not have to take is the fallout from incomplete, inaccurate and misleading reports in the press. We hope we can expect more balanced and accurate coverage from The Inquirer in the future.
Robert W. Stevenson
Vice President Cell Pathways Inc. |