Frequently Asked Questions
about the C. novyi-NT Program
How is the C. novyi-NT human clinical trial going?
It is very early in the C. novyi-NT human clinical trial process. It is important to note that experimental therapies like C. novyi-NT take many years of work and that most experimental therapies fail during testing. The C. novyi-NT program is currently in Phase 1 testing, the earliest stage of clinical trials. Phase 1 trials focus on evaluating a therapy’s safety and determining the appropriate amount of treatment to use. Later phases test the therapy’s effectiveness.
The initial demonstration that C novyi-NT therapy can destroy naturally occurring cancers is an important step forward in this line of research, but many steps and many years of work remain. The next steps include studies on more human patients to learn what tumor types are susceptible to this form of therapy, what dose of C novyi-NT should optimally be used, and what kinds of other medicines can best be combined with C novyi-NT to achieve the most favorable responses. Should these clinical trials be successful, we may be able to initiate more advanced trials in the future. We work very closely with the US Food and Drug Administration (FDA) and other regulatory agencies throughout the process.
We are encouraged by our preliminary results with C. novyi-NT, but it is important to remember that we are at an early stage in a very long, complicated and challenging process.
What hospitals and clinical study sites are testing C. novyi-NT treatment in humans?
Information about hospitals and clinical study sites that are evaluating C. novyi-NT treatment in humans can be found on the clinical trial’s record at ClinicalTrials.gov. The clinical trial identifier for the study is NCT01924689. ClinicalTrials.gov is a government-run registry and results database of human clinical trials conducted worldwide.
Is the C. novyi-NT human clinical trial enrolling new participants?
The C. novyi-NT human clinical trial is enrolling new participants, but the number of slots is extremely limited. Currently, we can enroll about one patient per month in the trial. To qualify for the very limited number of openings, physicians must first confirm that the patient meets specific criteria that are needed for the trial to provide meaningful results. We are working as quickly as possible to determine the safety and efficacy of C novyi-NT treatment to advance this potential therapy to the next stage in development. Information about other human clinical trials that are enrolling patients with cancer may be found at ClinicalTrials.gov.
When will a human C. novyi-NT therapy be available?
We estimate that it will be about 5 to 10 years before C. novyi-NT might receive regulatory approval as a human therapy. The development of any therapy is a long and challenging path. In fact, 9 out of 10 candidates fail along the way. Even if a therapy succeeds, it typically takes more than a decade to collect all the data necessary to meet the guidelines for FDA approval. We have many more years of studying C. novyi-NT treatment ahead of us to evaluate its safety and efficacy.
How can I stay informed of the progress of C. novyi-NT human clinical trials?
We will provide periodic updates on significant events through scientific publications, our website and press releases.
Is the C. novyi-NT clinical trial for dogs with cancer enrolling new participants?
Unfortunately, we are not currently enrolling canine patients for clinical trials. BioMed Valley Discoveries is focused on the development of C. novyi-NT as a possible treatment for humans. There are currently no plans to pursue an animal therapeutic.
How Can I Help?
BioMed Valley Discoveries is not accepting contributions or investments at this time. As a member of the Stowers Group of Companies, BioMed Valley Discoveries receives its funding principally from an endowment supporting the Stowers Institute for Medical Research. More information about contributing to the Stowers Institute for Medical Research can be found here. The Stowers Group of Companies has a controlling interest in American Century Investments, a leading global asset management firm. Each year more than 40 percent of American Century Investments’ profits are distributed to the endowment that funds the Stowers Institute. Since 2000, total dividend payments have exceeded $1 billion. More information about American Century Investments’ “Profits with a Purpose” can be found here.