About ABV-1702 for MDS
Product Overview
The global myelodysplastic syndrome (MDS) drugs market size was valued at USD 1.3 billion in 2016 and is expected to register a CAGR of 9.7% over the forecast period. The market is primarily driven by the emergence of novel therapeutics. The rising geriatric population, increasing incidence of niche indications and improving healthcare services are some of the key factors expected to drive the market. Myelodysplastic syndrome is caused by the mutation of one or more genes that control development of blood cells. It is one of the most common malignant hematological diseases that affects five out of every 100,000 people in U.S. annually. An estimated 60,000 people in U.S. live with MDS, and approximately 10,000-15,000 new cases are reported each year.
ABV-1702 shares the same API, extract from Grifola frondosa Maitake mushroom, and immune-modulation effects in peripheral blood as ABV-1501. In 2012, the Maitake mushroom extract was studied in a Phase II trial conducted at Memorial Sloan Kettering Cancer Center (MSKCC) to examine the effects of innate immune function in 21 myelodysplastic syndromes (MDS). The study results showed that Maitake mushroom extract was well tolerated and as a result ABV-1702 was approved by U.S. FDA in 2016 for a clinical trial for the treatment of MDS. The selection of principal investigators and U.S. clinical sites is currently in progress.
INDICATED USE
- Myelodysplastic Syndrome (MDS)
DEVELOPMENT PARTNER
- TBD
DEVELOPMENT STATUS
- US FDA IND approved (Phase II MDS Trial)
- The selection of principal investigators and U.S. clinical sites is currently in progress.
PATENT STATUS
- Patent Granted in the United States, Great Britain, Japan, Germany, France, Italy, China, and Taiwan
TOXICOLOGY
- No dose-limiting toxicity encountered
CLINICAL TRIAL
- Preparing Phase I Trials
SAFETY
- ABV-1702 has been used for more than 10 years as functional food
MDS – ABV-1702 Development Timeline
DISCLAIMER: Clinical trials may be in early stages. There is no guarantee that any specific outcome will be achieved. Investments may be speculative, illiquid and there is a risk of loss. Past performance is not indicative of future results.