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ENMD-2076, an oral Aurora A/angiogenic kinase inhibitor has received an orphan drug designation from the Food and Drug Administration to treat hepatocellular carcinoma, according to a statement issued by the manufacturer on July 7. With that status, maker CASI Pharmaceuticals will be able to market the drug exclusively for 7 years, solicit additional funding for research, and receive clinical protocol assistance.
"The Orphan Drug designation ... confirms our belief in the versatility of ENMD-2076 as a promising treatment for HCC, and for other tumor types that we are currently evaluating in the clinic," Dr. Ken Ren, chief executive officer of CASI, said in the statement. "We are finalizing our next steps for ENMD-2076 in HCC and/or in fibrolamellar carcinoma, a subset of HCC for which there is no treatment available."
ENMD-2076 has multiple mechanisms of action and has been shown to inhibit distinct angiogenic tyrosine kinase targets in addition to the Aurora A kinase. The Aurora kinases are regulators of cell division that are often over-expressed in human cancers. The drug also targets other kinases, VEGFR, Flt-3, and FGFR3, which play roles in several cancers. ENMD-2076 showed positive activity in phase I clinical trials in solid tumor cancers such as ovarian, breast, liver, renal, and sarcoma; activity was also shown in leukemia and multiple myeloma.
ENMD-2076 has already received orphan drug designation from the FDA for the treatment of ovarian cancer, multiple myeloma, and acute myeloid myeloma.
ENMD-2076, an oral Aurora A/angiogenic kinase inhibitor has received an orphan drug designation from the Food and Drug Administration to treat hepatocellular carcinoma, according to a statement issued by the manufacturer on July 7. With that status, maker CASI Pharmaceuticals will be able to market the drug exclusively for 7 years, solicit additional funding for research, and receive clinical protocol assistance.
"The Orphan Drug designation ... confirms our belief in the versatility of ENMD-2076 as a promising treatment for HCC, and for other tumor types that we are currently evaluating in the clinic," Dr. Ken Ren, chief executive officer of CASI, said in the statement. "We are finalizing our next steps for ENMD-2076 in HCC and/or in fibrolamellar carcinoma, a subset of HCC for which there is no treatment available."
ENMD-2076 has multiple mechanisms of action and has been shown to inhibit distinct angiogenic tyrosine kinase targets in addition to the Aurora A kinase. The Aurora kinases are regulators of cell division that are often over-expressed in human cancers. The drug also targets other kinases, VEGFR, Flt-3, and FGFR3, which play roles in several cancers. ENMD-2076 showed positive activity in phase I clinical trials in solid tumor cancers such as ovarian, breast, liver, renal, and sarcoma; activity was also shown in leukemia and multiple myeloma.
ENMD-2076 has already received orphan drug designation from the FDA for the treatment of ovarian cancer, multiple myeloma, and acute myeloid myeloma.
ENMD-2076, an oral Aurora A/angiogenic kinase inhibitor has received an orphan drug designation from the Food and Drug Administration to treat hepatocellular carcinoma, according to a statement issued by the manufacturer on July 7. With that status, maker CASI Pharmaceuticals will be able to market the drug exclusively for 7 years, solicit additional funding for research, and receive clinical protocol assistance.
"The Orphan Drug designation ... confirms our belief in the versatility of ENMD-2076 as a promising treatment for HCC, and for other tumor types that we are currently evaluating in the clinic," Dr. Ken Ren, chief executive officer of CASI, said in the statement. "We are finalizing our next steps for ENMD-2076 in HCC and/or in fibrolamellar carcinoma, a subset of HCC for which there is no treatment available."
ENMD-2076 has multiple mechanisms of action and has been shown to inhibit distinct angiogenic tyrosine kinase targets in addition to the Aurora A kinase. The Aurora kinases are regulators of cell division that are often over-expressed in human cancers. The drug also targets other kinases, VEGFR, Flt-3, and FGFR3, which play roles in several cancers. ENMD-2076 showed positive activity in phase I clinical trials in solid tumor cancers such as ovarian, breast, liver, renal, and sarcoma; activity was also shown in leukemia and multiple myeloma.
ENMD-2076 has already received orphan drug designation from the FDA for the treatment of ovarian cancer, multiple myeloma, and acute myeloid myeloma.
