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Niiki Pharma Announces the Completion of Phase I Dose Escalation for First-in-Man Anti-Cancer Agent NKP-1339
Date:1/17/2012

HOBOKEN, N.J. and PHILADELPHIA, Jan. 17, 2012 /PRNewswire/ -- Niiki Pharma Inc. announced today that it has completed the dose escalation portion of the Phase I clinical trial of its lead product, NKP-1339. NKP-1339 is a first-in-class small molecule that down-regulates GRP78, a key tumor survival and anti-apoptosis factor.

The NKP-1339 single agent dose escalation Phase I trial was conducted in patients with advanced solid tumors resistant to multiple, standard therapies. NKP-1339 was administered intravenously once weekly for 3 weeks followed by one week of no treatment. Thirty-four patients were treated, of which 30 were evaluable for dose determination. The NKP-1339 Phase I trial is being led by Dr. Daniel Von Hoff, Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare in partnership with Translational Genomics Institute, and Dr. Howard Burris, at the Sarah Cannon Research Institute.

The NKP-1339 dose limiting toxicity was grade 2-3 nausea and grade 1-2 reversible renal insufficiency. At the recommended Phase II dose, NKP-1339 treatment was generally well tolerated and had manageable side effects. The most common drug-related side effects were grade 1 nausea, grade 1-2 vomiting and grade 1-2 fatigue. Infusional fever and chills were noted but prevented with steroid premedication.

"We reached our goal to determine the dose of NKP-1339 to take forward in future trials. Many toxicities commonly associated with other anticancer drugs, such as neutropenia, hepatotoxicity, neuropathy, rash, mucositis, diarrhea and alopecia, have not been seen to date," said Dr. Burris.

Anti-tumor activity, demonstrated by disease stability and/or tumor regression for 12-88+ weeks, was noted in patients with neuroendocrine tumors (NET), non-small cell lung cancer, sarcoma, colorectal and cancer of unknown primary. Three patients continue to receive NKP-1339 therapy on study.

"The preliminary read of NKP-1339 anti-tumor activity
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SOURCE Niiki Pharma Inc.
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