Healthcare Industry News: U.S. Food and Drug Administration
News Release - July 9, 2018
OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC)First Orphan Drug Designation for OBI-3424, a novel first-in-class targeted therapy for solid tumors that express aldo-keto reductase 1c3 (AKR1C3) enzyme
TAIPEI, Taiwan, July 9, 2018 -- (Healthcare Sales & Marketing Network) -- OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC). OBI-3424 is a first in class DNA alkylating cancer therapeutic agent targeting aldo-keto reductase 1C3 (AKR1C3) overexpressing cancers.
A Phase 1/2 study of OBI-3424 in patients with solid tumors, including hepatocellular carcinoma (HCC) and castrate-resistant prostate cancer (CRPC), has commenced enrollment at the University of Texas M.D. Anderson Cancer Center.
Amy Huang, General Manager of OBI Pharma, noted, "The orphan drug designation for OBI-3424 by the FDA is a significant step in the development of this drug candidate. OBI-3424 is intended to treat a devastating form of Liver Cancer with limited therapeutic options. We are excited that the FDA has recognized the need to develop novel targeted therapeutic agents such as OBI-3424 in the fight against this disease."
About Hepatocellular Cancer (HCC)
Hepatocellular Carcinoma (HCC) is a form of liver cancer associated with various stages of malignant growth in the liver. It is the sixth most common cancer worldwide, but is rare in the United States with a prevalence of 61,483 cases in 2018. HCC is considered a lethal cancer, with a survival rate of around 12.2% for five years, and the third major leading cause of cancer-related deaths worldwide. While most liver cancers are preventable, the incidence of HCC has recently increased in the United States, possibly due to the prevalence of common risk factors such as chronic liver disease, viral liver infections such as hepatitis, and cirrhosis. HCC patients also have a high risk of developing drug resistance to standard of care (SoC) treatments, creating a need for alternative treatment.
About Orphan Drug Designation (ODD)
The orphan drug designation provides OBI Pharma with potential benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees, and tax credits for qualified clinical trials. The FDA's Office of Orphan Drug Products grants orphan status to support development of medicines for rare diseases or conditions that affect fewer than 200,000 people in the U.S.
OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3), and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective.
AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult-to-treat cancers including: hepatocellular carcinomas (HCC), castrate-resistant prostate cancer (CRPC), and T-cell acute lymphoblastic leukemia (T-ALL). AKR1C3 is highly expressed in up to 15 solid and liquid tumors.
OBI Pharma holds worldwide rights for OBI-3424 with the exception of the following countries, whose rights are held by Ascenta Pharma: China, Hong Kong, Macao, Taiwan, Japan, South Korea, Singapore, Malaysia, Thailand, Turkey, and India.
About OBI Pharma
OBI Pharma, Inc., is a Taiwan biopharmaceutical company that was established in 2002. Its mission is to develop and license novel therapeutic agents for unmet medical needs against cancer targets such as Globo Series (including Globo H), AKR1C3, and other promising targets.
The company's novel first-in-class immuno-oncology portfolio against Globo Series includes: Adagloxad Simolenin (formerly OBI-822), a Globo Series active immunotherapy vaccine; OBI-888 (Globo H mAb) and OBI-999 (Globo H ADC). The company's novel first-in-class AKR1C3 targeted therapy is OBI-3424 (small-molecule prodrug) that selectively releases a potent DNA alkylating agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme. Additional information can be found at www.obipharma.com.
Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma's reports and presentations, including OBI Pharma's filings with the Taiwan Securities and Futures Bureau.
Source: OBI Pharma
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