It’s a time of anticipation: as researchers stand at the edge of the unknown and set out towards new territory in Phase I clinical trials, they’re charting answers to scientific questions for the very first time. While preclinical research provides a map and compass guiding how to proceed, it’s a whole new ballgame when novel treatments are tested on the human body.
Phase I isn’t just closely monitoring reactions and deciphering the appropriate dosage. It’s the beginning of tearing down the walls of long-standing research barriers and expanding the realm of modern medicine’s capabilities.
2019 is still young, but Phase I clinical researchers have already announced many exciting advancements. At Medrio, we’re always keeping track of headlines from the world of Phase I clinical trials so we can stay attuned to the issues that matter to our many Phase I customers – here are some of the recent stories that have us excited about the prospect of a Phase I breakthrough.
1. The Power of dMAb and a Zika Vaccine Candidate
“This is a completely novel technology that could change the way we deliver antibodies as therapeutic agents and may have the potential to be fast-tracked into clinical trials.” — Dr. Pablo Tebas, M.D.
A new Phase I clinical trial using dMAb technology is creating antibodies to Zika directly in the human body. Here are just a few reasons this is significant:
• Zika poses a health risk in almost half the world’s countries.
• Previously, monoclonal antibodies could only be created in bioreactors.
• dMAb could also be useful in fighting the flu, Lyme disease, and cancer.
2. Immunotherapy and our pets
“It’s the first time that dogs with osteosarcoma have experienced prolonged survival without receiving chemotherapy, which is really exciting.” — Jeffrey Bryan, DVM, Ph.D.
Last year we published a blog discussing how research on dogs may lead to improved treatments for humans. Here’s an update:
• Using a vaccine created from a dog’s own tumor, researchers have increased remission from 270 days to 400 days.
• Researchers are now optimizing this therapy for FIH Phase I trials.
3. A functional cure for type I diabetes?
“For this patient population, a beta cell replacement therapy . . . can potentially provide a functional cure.” — PR Newswire, ViaCyte, Inc.
A human stem cell-derived product candidate for type 1 diabetes marks a step towards ending a lifelong dependency on daily insulin administration and vastly improving life quality for many.
• Currently, human cell implants can restore insulin production and glucose control, but a lack of donors limits widespread use of this approach.
• The stem cell implants presently in Phase I clinical trials have the potential to overcome donor limitations and offer a more effective long-term treatment.
4. Promising results from a Phase I clinical trial for ALS
“It is a huge breakthrough, and we look forward to confirming the positive results in a larger study soon.” — Ashley Bush, Director of Melbourne Dementia Research Center
The results of a groundbreaking trial have found that a new treatment for Amyotrophic Lateral Sclerosis (ALS) slows the overall progression of the disease and allows patients to regain some lung function and cognitive ability.
• 5,000 people are diagnosed with ALS each year.
• Until now, there has been no effective treatment or cure for the disease.
• Most people survive just 2-5 years after diagnosis.
5. A malaria vaccine for pregnant women
“It is a great milestone for us to be able to show that our vaccine is completely safe and induces the exact antibody response in the blood we want.” — Morten Nielsen, Ph.D., Senior Study Investigator
Malaria is a leading cause of death worldwide, having an especially harmful effect on children and pregnant women. Phase I clinical trial data from a new vaccine show encouraging results:
• This new product demonstrated the desired immune response connected with protection from pregnancy-associated malaria (PAM).
• The next step in Phase II is to document if the vaccine prevents pregnancy malaria in women who would otherwise suffer from the disease.
While all phases of the clinical trial process play an indispensable role in the development of new treatments, Phase I is where discovery and innovation truly begin. That’s why, as an eClinical provider focused largely on the needs of Phase I researchers, we’ve had a front-row seat for some pretty amazing discoveries. We’re proud Phase I researchers everywhere who are working to find answers to questions that can have a major impact on public health.