Kinex receives FDA approval to begin Phase I study of KX2-391 Ointment for actinic keratosis -
Kinex Pharmaceuticals announced the receipt of an allowance by the US FDA for the Company's 391 KX2- ointment for the start of a clinical phase I study in actinic keratosis. This is the third IND in the Company to be approved by the US FDA in the last 12 months.
KX2-391 is a synthetic, orally active, highly selective inhibitor of Src tyrosine kinase signaling and tubulin polymerization. KX2-391 promotes the induction of p53, the G2 / M arrest of proliferation of the cell population and subsequent apoptosis through the stimulation of caspase-3 and cleavage of PARP. potent inhibition of the growth of human keratinocytes, and several melanoma cell lines in vitro suggests the potential clinical activity for actinic keratosis and skin tumors. In addition, KX2-391 has also been observed to inhibit T cell migration and the formation of endothelial tubules in vitro , which suggests additional potential therapeutic benefits for skin diseases such as psoriasis, wherein the condition is supported by a lymphocyte infiltration, inflammation and / or angiogenesis.
"The encouraging preclinical data for KX2-391 ointment has allowed us to progress in this clinical study. Actinic keratosis is a premalignant condition and perfectly into our portfolio in oncology," said the dr. Rudolf Kwan, Chief medical Officer of KINEX pharmaceuticals.
Kinex has authorized the use of KX2-391 for dermatological indications in the territory of Greater China to a company specializing in pharmaceutical formulations, . PharmaEssentia Corp. (Taipei, Taiwan) the scientific head of the project at PharmaEssentia, Dr. Jer Hsu said: "I congratulate our team for the successful development of the formulation of KX2-391 in collaboration with our excellent ointment collaborative partner, KINEX Pharmaceuticals. We are also leading the effort to advance this formulation for clinical indication of psoriasis in Taiwan. " KoChung Dr. Lin, CEO of PharmaEssentia said: "We are delighted to see the successful collaboration of the provision for the KX2-391 for actinic keratosis IND by the FDA. We also look forward to ask for a Taiwan IND for KX2-391 ointment and the launch of our clinical development program for psoriasis in Taiwan. our collaboration with Kinex has been rewarding and we will use our collective drive to bring KX2-391 ointment clinical Asia quickly. "
KX2-391 is being developed as an oral agent for oncology indications and has been tested in four clinical studies to date. In defining its pharmacological activity in tumor cells , both in vitro and in vivo , KX2-391 showed potent activity against a broad range of solid tumors as well as leukemia cell lines, including lines cell resistant to anticancer drugs currently used. Kinex also collaborated with Hanmi Pharmaceuticals (Seoul, Korea) to develop the oral formulation of KX2-391 for oncology indications in Korea and China Territory. in partnership with Hanmi Pharmaceuticals, the safety, tolerability and pharmacokinetics of KX2-391 were studied in 0 patients in both solid and liquid tumors. a study of KX2-391 in combination with paclitaxel is currently being conducted in South Korea and sponsored by the collaboration with hanmi Pharmaceuticals.
Dr. Chan Wing Kai, Head of Clinical Operations for Asia-Pacific for Kinex, said: "The ability to develop new topical formulation of KX2-391 for hyper-proliferative skin diseases shows how Kinex is actually built a pipeline of drug candidates. I look forward to working with our partner PharmaEssentia to initiate clinical trials of KX2-391 ointment for psoriasis, and KX2-391 orally for leukemia and other cancer indications . "
EmoticonEmoticon