Vanessa Biotech will soon sponsor clinical trials of Shylicine™. To learn more about these trials, please contact us.
Our team at Vanessa Biotech is working on the first medicine that can treat microvillus inclusion disease, with the ultimate goal of eliminating the patient’s dependence on intravenous nutrition or TPN, and the need for a bowel transplant. These current treatment options limit a child’s quality of life and bring the risk of serious complications. With our research, we hope to change the way doctors and clinicians view the disease and prescribe treatment.
At the Yale School of Medicine, Dr. Dmitry Kravtsov identified the role that intestinal cell immaturity plays in the severity of diarrhea. His research suggested that the failure of the MVID intestine may not be permanent, and that the immature cells of the gut may be able to grow again. Armed with this understanding and combined with an exhaustive review of the literature from the past twenty-five years, our team has developed a cocktail drug formulation called Shylicine™. We envision Shylicine™ to be a treatment that does not require any form of surgery or medical procedure, and can be taken at home in a convenient oral form, without a medical professional or training.
The goal of our treatment is to:
Help the intestine absorb water and nutrients,
Reduce excessive secretion of ions and water,
Increase the absorptive surface of the intestine by restoring the villi and microvilli, and
Maintain the required integrity of the intestinal barrier.
MVID Intestine Under Treatment:
Our goal with Shylicine™ is to helps the cells of intestinal epithelium to regain their mature status. Correcting maturation abnormality helps to restore normal villus length and appearance and enables epithelial cells to regain the absorptive function.
Like all new drugs, Shylicine™ is subject to regulatory and quality standards as a therapeutic for use in humans, therefore it will not be available in the United States and other markets until it receives regulatory approval. Currently Shylicine™ is limited to investigational use only and is not available for sale.
Presentation at Quinnipiac University Rare Disease Day 2018
Dmitry was invited to give a presentation on microvillus inclusion disease at Quinnipiac Rare Disease Day 2018. His presentation focuses on the mechanism of action behind MVID, Shylicine and what it means to be a researcher in the area of rare diseases. We hope you enjoy his presentation and that you can further expand your knowledge on MVID.
What is a clinical trial?
In every drug development process, the most important step is to verify safety and efficacy of the drug in targeted populations. This is done during the clinical trials which are specially designed studies with people who volunteer to receive the drug and be observed for its effects.
Only drugs that are carefully analyzed and found safe in animals can enter clinical trials. Testing the drug in patients having the disease is the only definitive way to confirm that the drug works as predicted. But before this can happen, people must volunteer and participate – a choice that may benefit not only the individual but many others as well.
Whether or not you qualify for a clinical trial depends on a number of factors, including your medical condition. You should discuss your interest in being involved in a clinical trial with your physician, and ask your physician for more information on your eligibility and the clinical trial itself. Participation in a clinical trial can be a great undertaking, and there are no guarantees that the investigational drug will work.
Participating in Shylicine™ trials
The success of clinical trials depends on the participation of volunteers. Participants in clinical trials gain access to new research treatments not yet available to the public while helping others by contributing to medical research.
Vanessa Biotech will now start its Phase 2 clinical trials in the third quarter of 2018. The primary objective of the Phase 2 clinical trials is to test the clinical activity and efficacy of Shylicine™ for the treatment of diarrhea in MVID. In addition, VB expects to verify the reduction in patient dependency on TPN and register changes in intestinal morphology. The trial is anticipated to last 8 weeks. Contact us for more information about clinical trial plans or check this website regularly.
DISCLAIMER: The information included on this site reflects Vanessa Biotech’s clinical development pipeline and is not intended for promotional purposes. Shylicine™ is under clinical development. There are significant risks and uncertainties in pharmaceutical research and development. Scientific and regulatory hurdles may cause pipeline product to be discontinued, delayed or fail to reach the market. There can be no guarantee that pipeline product will receive regulatory approval or that they will prove to be commercially successful. Information is current as of November 15, 2017. Vanessa Biotech assumes no duty to update this information.