BioSpecialist Wednesday, 07/08/09 06:25:15 AM Re: None Post # of 24 CMO is optimistic for MCC in Bladder Cancer An interview with Dr. Francois Charette, Chief Medical Officer at Bioniche Life Sciences Inc. What is a clinical trial? Clinical trials or clinical studies test potential treatments to see if they are effective and safe. New products must be studied in laboratory animals first to evaluate potential toxicity before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise are then moved into clinical trials. Clinical trials are an integral part of new product discovery and development, and are required by regulatory authorities before a new product can be commercialized. Why participate in a clinical trial? People volunteer to participate in clinical trials for different reasons. Many volunteer because they want to help advance medical knowledge. Others have tried all available treatments for their condition without success. Although efforts are made to control risks to clinical trial participants, some risk may be unavoidable because of the uncertainty inherent in clinical research involving new medical treatments. I have a lot of respect for participants. Without their contribution, we would not be able to develop new products. Who can participate? It's important to test new treatments in the people they are meant to help. Trial guidelines, or eligibility requirements, are developed by the researchers and usually include criteria for age, sex, type and stage of disease, previous treatment history, and other medical conditions. Some trials involve people with a particular illness or condition to be studied, while others seek healthy volunteers. Inclusion or exclusion criteria help identify appropriate participants and help to exclude those who may be put at risk by participating in a trial. What happens in a clinical trial? Every clinical trial is designed to answer certain research questions. A trial plan called a "protocol" maps out what study procedures will be done, by whom, and why. The clinical trial team includes doctors and nurses as well as other health care professionals. This team checks the health of the participant at the beginning of the trial and assesses whether that person is eligible to participate. Those found to be eligible - and who agree to participate - are given specific instructions, and then monitored and carefully assessed during the trial and after it is completed. Is Bioniche currently conducting clinical trials? Bioniche is currently conducting a clinical trial in bladder cancer with Mycobacterial Cell Wall-DNA Complex (MCC). MCC is a formulation of cell wall fragments from a type of mycobacterium which is found in soil, on plants, and in drinking water and which does not cause disease. It contains no animal or preservative by-product, thereby decreasing the risk of any harmful or allergic reactions. MCC is a sterile product, which means that there are no live organisms in the preparation. What is involved in running the clinical program with MCC for patients with bladder cancer? Our first priority in organizing a study for patients with bladder cancer is to make sure that everyone is treated safely with an opportunity of obtaining good results in their treatment against cancer. We write up protocols in collaboration with the top world expert urologists and then collaborate with clinical centres that have the experience in dealing with products under investigation. All centres must receive approval from an Ethical Review Board (ERB) before starting to recruit patients. What is the design of the first trial that is underway? One problem in the treatment of bladder cancer is that not everyone can be cured with the available medication. Even if the cancer is still superficial (it has not entered into the wall of the bladder), it is not easy to take out or to treat with drugs that are put in the bladder. Our first trial is for patients that have not responded to a medication called Bacillus Calmette-Guérin (BCG). There are not many options available for these patients. Many of them eventually need to have their bladder removed (a procedure called a cystectomy). We hope that MCC will be able to take care of some of the bladder cancers that have not done well with BCG. How are patients identified for this trial? We work very closely with 25 urology centres in North America (Canada and the U.S.). Urologists from these centres propose this product under investigation to the patients that have not done well with BCG. Other patients will, after learning by themselves about MCC, contact us or their urologist to find out if they are eligible for this experimental treatment. They can then be eventually referred to a research site. When will the first trial be completed? We anticipate that recruitment in the first trial will be completed by mid-2008. The target is to enroll 105 patients. How can someone get additional information about this trial? There are different ways to obtain more information on this trial. Our study is listed on the website www.clinicaltrials.gov. This website provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The National Health Institute (NIH), through its National Library of Medicine, has developed this site in collaboration with all NIH institutes and the FDA. For more information about the MCC clinical program, please contact Bioniche Therapeutics at 1-800-567-2028 or [email protected] When will the results of the first trial be submitted for review by the FDA? We will follow the patients of this first trial for five years, but will submit results to the FDA after all patients have been in the study for a minimum of one year. Are you able to discuss the results that you are seeing in the first trial? We cannot discuss results before the study is completed. The reason for this is to reduce bias (patients or physicians beginning to think that the product is effective or not) before the study results are analyzed. However, during the trial, there is a committee that is independent from our Company that will look at the results regularly to make sure that everything is going well and that there is limited risk for the patients. This committee is called the Data Safety Monitoring Board. Will the results be available to the patients/public? We are committed to make the results of all of our trials public. They will be presented at scientific meetings and there will be press releases to announce the results to everyone. Will the second trial start before the first one ends? We expect to begin our second trial in the first quarter of 2008, before the first trial ends. What is the design of that trial? The second trial will be for all patients that have a superficial (also known as non-invasive) bladder cancer that is at high risk of recurring (coming back) after surgery or at high risk of progression (that may invade the bladder wall). These are usually high grade cancers, which means cancers that are somewhat more dangerous than other types of bladder cancers (low grade). The usual treatment for these cancers after tentative complete surgical removal is to instill (put in the bladder through a small tube) a product called Bacillus Calmette-Guérin (BCG). This treatment is effective most of the time, but there are also patients for whom it is not effective. Many patients have difficulty tolerating this treatment in particular because BCG is a live microbe, a mycobacterium that causes an infection in the bladder. The second trial will compare our product to BCG. At this time, we think that MCC is as good as BCG to support the cure of the patient, but will be better tolerated, with fewer side effects. What is your expectation for the two Phase III trials with MCC? I am optimistic that we will be able to show that MCC is an effective and safe product for the treatment of bladder cancer. There is an unmet need for new, better and safer therapies for bladder cancer and I hope we will meet the challenge of addressing this need. What can you tell us about the Bioniche Therapeutics clinical group? We have a great team working diligently to advance the science and demonstrate the clinical value of new treatments. The group has considerable expertise in developing new products and strong academic credentials. Moreover, these men and women are dedicated to making it all happen and take pride in their efforts to bring a new product to bladder cancer patients. Other than bladder cancer, what is the focus for the Bioniche Therapeutics clinical group? The team will also be looking at the possibility of treating other cancers using the MCC product. The development for these other cancers is much less advanced. There is however, once again, the possibility of advancing medical science for the benefit of patients. This keeps the group very motivated.