RE:RE:RE:RE:Mouse to Rat To Human TrialsPatK, I had indicated I would not be back for a week but your discussion caught my interest as I scanned these posts. I may have been one of those who dissed the topic of cancer trials in pets a few months back because it had nothing to do with the immediate goal of focusing on ph1/2a start up and not diluting what little funds remain to complete this trial. However, you make a good argument. Bladder cancer is unique from other solid tumors and that protocol is set. However, pending the trial start, it will be at least 2-3 years before another solid tumor trial thru TLT is started. I've attached an excerpt from U of Missouri Veterinary Oncology that gives an overview of cancer trials in pets. The topic of larger sized tumors than the 5mm in mice trials could be addressed with dogs (horses might be better). Key phrases relative to data collected: mammalian tissue; larger sized tumors; % PDC dispersion in tumor; immune/vaccine response if dispersion not 100%; safety data from the 4 PDC bladder candidates. I am certain that the FDA/Health Canada would require follow up trials in humans but, relative to discussions with pharma/biotech, if efficacy and safety were confirmed in the bladder trial then a positive outcome in animal data on large solid tumors acquired in veterinary oncology trials would be strong motivation for pharma to seal a deal with TLT. The following is from the U of Missouri- Veterinary Oncology General Information about Clinical Trials but the same is also found at Ohio State, Colorado State or 10 other Universities. The question is whether TLT is aware of animal oncology trials? What is a clinical trial? A clinical trial is a research study in which animals with cancer participate to evaluate aspects of, or novel treatments for, cancer. Well-designed clinical trials can answer questions about preventing, detecting, and treating cancer that help many animals in the future. Trials are designed to minimize risk to the participants, but drug trials often involve new anti-cancer agents that may not have been used in companion animals, and the extent of possible toxicity is not known. There are four phases of clinical trials to safely and methodically evaluate promising new treatments. Phase 1 trials are typically conducted in a small group of animals (6-12) with cancer to test a new treatment that has never been tried in a clinical patient. The goals are to evaluate safety and side effects, and to determine the dose and way to use the treatment. It is important to remember that no therapeutic benefit is expected in a phase 1 trial. Current Clinical Trials Trials at other Institutions Phase 2 trials use information from phase 1 trials to use the new treatment at a given dose and schedule in a larger group of animals with cancer (usually 20-40). The goal of a phase 2 trial is to determine efficacy of the new treatment and further evaluate safety. In cancer clinical trials, a phase 2 trial is intended to determine what types of cancer will respond or how well a given cancer responds to a new therapy. Phase 3 trials compare the new treatment to standard treatment options in a large group of animals with cancer. The goal is to determine whether the new treatment is better than other common treatments and to further monitor safety and side effects. Phase 4 trials compare two or more well-established treatment regimes in a given group of patients, typically after the treatment has already been approved for use (in people) or in common use (in animals). Standard of care: This phrase is used to describe the treatment that is most commonly used for a certain cancer by most veterinary oncologists currently in practice. Standard of care may be determined by past clinical trials, or may be the result of opinions formed when treating animals over time. In the absence of good-quality, controlled clinical trials, or in the event that properly designed trials have not found a treatment that benefits the patient, there may not be a standard of care established by the veterinary oncology community for a given cancer. Benefits of a clinical trial: Owners of animals with cancer, as advocates for their companions, may choose to participate in a clinical trial for a number of reasons. The knowledge gained in clinical trials benefits countless animals in the future. Additionally, interventional trials such as Phase 3 and 4 trials may allow a patient to benefit from a promising new treatment before it is widely available. What research has been done before a clinical trial is initiated? Depending on the phase of research, various questions may have been answered. Prior to phase 1 studies, preclinical work may include research with cell culture or rodents, and new drugs have typically been given to healthy animals before they are offered to animals with cancer in order to determine expected side effects and a general idea of dose and safety.