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Samumed Granted Orphan Drug Designation for SM08502 for the Treatment of Pancreatic Cancer
Phase 1 Data Expected the First Half of 2019
SAN DIEGO, Jan. 03, 2019 (GLOBE NEWSWIRE) -- Samumed, LLC, announced today that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) for SM08502 for the treatment of pancreatic cancer. A phase 1, open‐label, multicenter, dose escalation study is currently evaluating the safety, tolerability, and pharmacokinetics (PK) of orally administered SM08502 in subjects with advanced solid tumors.
“The FDA ODD designation for SM08502 is an important regulatory milestone and highlights the importance of finding treatments for a significant unmet need in pancreatic cancer,” said Dr. Yusuf Yazici, Chief Medical Officer of Samumed.
About Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer death in both sexes. Symptoms do not usually appear until the cancer has progressed to late stages, which contributes to the high mortality rate. Risk factors include cigarette smoking, obesity, diabetes, excessive alcohol consumption, and a family history of pancreatic cancer.1
- An estimated 55,440 new cases of pancreatic cancer were diagnosed in the US in 2018, equaling 3.2% of all new cancer cases1, 2
- An estimated 44,330 deaths from pancreatic cancer occurred in the US in 2018, or 7.3% of all cancer deaths1, 2
- After diagnosis, the five-year survival rate is 8.5%2
SM08502 is a small-molecule Wnt pathway inhibitor being developed for the treatment of advanced solid tumors. The mechanism of action of SM08502 has potential to attenuate the expression of genes that control differentiation and proliferation of tumor cells.
Samumed’s small-molecule drug platform is harnessing the innate restorative power of the Wnt pathway to reverse the course of severe and prevalent diseases. Learn more about Samumed’s potential regenerative drug candidates and broad clinical pipeline at: https://www.samumed.com/pipeline/default.aspx
- American Cancer Society. Cancer Facts & Figures 2018. (https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2018.html)
- National Cancer Institute; Surveillance, Epidemiology, and End Results Program; Cancer Stat Facts: Pancreatic Cancer, 2018. (https://seer.cancer.gov/statfacts/html/pancreas.html)
Josephine Belluardo, Ph.D.
LifeSci Public Relations