|Mendacious articles against Radient Pharmaceuticals taking toll on tabloid's credibility|
|Wednesday, 30 March 2011 09:39|
Around this time last year, a $250 million lawsuit was filed by another emerging company begged some of these same questions. Canadian-based Generex (OTC: GNBT) is still fuming about two articles the same columnist wrote expressing doubt about the company's oral insulin spray Oral-lyn for Type 1 diabetes, and questioning the strength of the data behind approval of the drug in other countries. The $250 million lawsuit against the publication is on-going.
Are that firm’s investors and management encouraging this type of “professional” behavior? Will they continue to be as supportive when their publication is hit with yet another lawsuit?
Our own research into the most deleterious of the articles; which simultaneously shaved tens-of-millions of dollars off Radient Pharmaceuticals' (AMEX:RPC) market-cap and caused NYSE Amex officials to halt-trading of the stock, has already proven many of the tabloid’s allegations to not only be out-right false, but irresponsibly ill-researched.
The legal eagles that Radient recently retained to fight a class-action lawsuit that resulted and appears based solely on that same havoc-wreaking hit-piece have taken careful note of our findings as well. We’re convinced the publication will be hearing from them, as well as SEC officials, if they haven’t already.
Tabloid Columnist Denies Link To Reality
In his latest rant, the columnist continues to publish injurious inaccuracies and in a seemingly desperate attempt to continue smearing Radient, their shareholders and upcoming results from a key validation study, the writer has taken to referencing his own, mendacious articles and obsfucations as proof to readers that what he is saying (over and over again now) is true. Even if as those same editorial discourses have been and continue to be proven to be less than accurate expositions, themselves.
This past month, the tabloid has published an unusual number of articles mentioning the small cap company more times than any other biotech or diagnostics firm. Each of those articles has painted Radient’s business negatively, causing both disruptions and headaches for not only officials and investors, but also officials at the Mayo Clinic. That, coupled with the writer’s recent aspersions against the company’s retail investors themselves has led observers on Wall Street to wonder as to the motives of the pundit and his managing editor(s).
Here, again, are some sobering facts verified not only by some of the clinicians and doctors involved in the study themselves, but also using legal documents and contracts filed with the SEC. It is worth noting that many of these officials at the firms we spoke to have been instructed not to speak to TheStreet.Com given previous misrepresentations by the publication as they relate to this matter and others. Instead, they are now referring calls about these matters to their legal teams.
The fact that the words “collaboration” and “partnership” are not used interchangeably by officials at the Mayo Clinic has been the basis for loud arguments and confusion among investors and observers of the Radient story alike.
Officials at the Mayo clinic seem extremely protective of the term “partnership” since they began in-house efforts to commercialize and develop the Mayo brand as a monetizeable, trusted standard (think Good Housekeeping seal) which they apparently intend to use as a future endorsement vehicle on various medical and pharmaceutical products.
In addition, any company seeking a “partnership” with the Mayo clinic must provide a financial stake in their pharmaceutical/medical product. Even those firms in full partnership with Mayo must clear any use of their name on marketing materials or public documents.
Meanwhile, the clinic continues to collaborate with other firms and researchers by not only providing Mayo Clinic core laboratory facilities and clinicians, but their Mayo Validation Support Services arm utilizes Mayo resources to deliver extensive validation capabilities and biospecimens as is the case in the collaboration and specific agreement with Radient.
It is worth noting that, contrary to the tabloid’s own repeated- yet baseless- theories, Mayo clinicians designed the study’s protocols in full collaboration with Radient officials and decided that in order for the double blind study to be scientific, effective or otherwise legitimate, Mayo clinicians would test the CEA test against all of their patient’s blood samples while Radient clinicians would run the same samples using their Onko-Sure test platform.
The protocol design insisted that two labs be used and that in order to save money, Radient’s labs would be used in conjunction with Mayo’s own labs. In addition, Mayo clinicians not only participated in the study hands-on, they specifically asked and were granted by the company the right to publish findings of the study once the results are validated if they so choose.
Dr. Robert Beart Jr., who joined the board of Directors of Radient Pharmaceuticals last July, served as Chairman of Department of Colorectal Surgery at the Mayo Clinic itself from 1976 through 1992. He helped oversee the work of Afsaneh Motamed-Khorasani, Ph.D., Director of Oncology at Radient Pharmaceuticals as the samples were tested during the Onko-Sure segment of the test.
At no time were these two recognized specialists and experts in colorectal diseases and cancer or their clinicians given any patient information or told which blood samples were not from cancer patients, and which were drawn from patients exhibiting stage I, II, III or IV cancer. During the entire time, Mayo Clinic officials held the key to the samples. Thus, as pointed out and confirmed by various clinicians and officials at both labs, Radient had no way of knowing which blood samples were which.
It is also important to note that officials at Mayo assigned a clinical study IRB protocol with a Mayo study number and a Mayo IRB number to Radient’s clinical validation study. Two of the Mayo scientists signed on to the study as the Principal and co-principal investigators after careful review and consideration of said protocols. All of this was done in detail and approved long before the study began.
At both labs, all the blood sample validations took place under the same conditions and in duplicate to ensure that the accuracy of the upcoming results-- currently being tabulated as quickly and accurately as possible by a third-party clinical research group who we were asked not to identify until the results are released in the days ahead.
As pointed out by numerous clinical investigators in previous published studies, patients with colorectal cancer often present with advanced disease and concomitant poor prognosis. The best known serum biomarker, carcinoembryonic antigen (CEA) is not recommended for screening because of its limited specificity and sensitivity. The purpose of using such a test to monitor colon cancer patients who have been treated for the disease (usually having undergone surgery to remove the cancer) is to see if the disease is recurring. Physicians in the field are looking for a way to find out whether the cancer returns in its early stages, because if they can do that, the lives of their patents can be saved over 90% of the time.
In the past, a number of other circulating proteins, including Radient’s DR-70 cancer test had been suggested to be used in tandem with CEA to help diagnostically detect colorectal cancer earlier and more accurately. Until now, none of the proteins have proven to be sufficiently sensitive or specific enough to establish a role in routine clinical practice, but if the results from this clinical validation study are able to prove a statistically measurable increase in detection accuracy over CEA alone, particularly for early stage cancers, that will present not only an important change to the industry, but it will also give doctors an opportunity to save more lives.
Again, according to previous interviews and discussions with Radient officials, the critical issue is not detecting colon cancer in its later stages IV and V, where the patent’s probability of surviving is slim (the current CEA test already performs these tasks really well), the aim is detecting the disease in Stage I and II and that’s where they hope Onko-Sure will prove to be a superior test. In addition, company officials are hopeful that study results can show significant data in regards to using both the CEA and Onko-Sure tests in combination as it pertains to enhancing the specificity or probability of detecting a recurrence of the disease, should it return to patients who are being monitored by their physicians.
Remember that the Onko-Sure test is based on Radient’s DR-70 cancer test technology, which has been approved by the US FDA for CRC monitoring and by Health Canada for Lung Cancer screening. According to officials at GenWay Biotech, who themselves partnered with Radient in 2009, a growing body of data reveals that the test is effective as a general cancer screen as well. The DR-70 ELISA assay quantifies Fibrin and Fibrinogen Degradation Products (FDP) in the blood, which are elevated in the presence of a malignant tumor and increase as the malignancy grows. International studies have linked the DR-70 cancer test to at least 14 different types of cancer, including lung, breast, stomach, liver, colon, rectal, ovarian, esophageal, cervical, trophoblastic, thyroid, malignant lymphoma, brain and pancreatic cancer, making it one of the most versatile cancer biomarkers available.
Given the trading action after the most recent attack, one thing has certainly become clear. The tabloid's credibility has definitely eroded.