Clinical Trials
Clinical trials are the backbone of the research and development process. It is through clinical trials that real drugs are tested on real people, producing real data for the insight and direction of pharmaceutical companies and the federal regulating agencies like the Food and Drug Administration (FDA). Without the help of patient volunteers and the far-reaching collaborations of physicians, research institutes, pharmaceutical companies and the government, clinical trials would not be possible. Most clinical trials are federally regulated and must follow stringent guidelines to produce safe, accurate and efficient data collection.
Vaxco Pharmaceuticals has submitted an Investigational New Drug Application to the FDA and is currently planning a Phase I/II clinical trial for a new vaccine, known as HCI001, to treat metastatic melanoma. Having shown unprecedented positive response in our laboratory testing and animal models with a success rate of 95%, Vaxco Pharmaceuticals is nearing its trial launch. We have however, through Schedule C, been able to treat one individual with this groundbreaking therapy on a compassionate use basis and his treatment showed promising response. Excited about the positive data gained from this compassionate treatment, we look forward to recruiting patients for the clinical trial.
Participation in clinical trials should not be taken lightly. Patients interested in these trials should know that though approximately 60% of drugs undergoing clinical trials are approved by the FDA and have shown positive results in laboratory and animal testing, they are still experimental and could have unknown side-effects and may provide unknown benefit. Despite the risks, clinical trials are an efficient way to obtain clear data on a new drug while providing patients an opportunity to benefit from the vast wealth of new technologies in the pharmaceutical industry's pipeline. For more information on clinical trials, please visit www.clinicaltrials.gov, a service provided by the United States National Institutes of Health.