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Niiki Pharma Announces Positive Interim Data from Ongoing Clinical Trial of Novel Anti-Cancer Agent NKP-1339
Date:9/20/2011

HOBOKEN, N.J. and PHILADELPHIA, Sept. 20, 2011 /PRNewswire/ -- Niiki Pharma Inc. announced interim results from the ongoing Phase I clinical trial of its lead product, NKP-1339. NKP-1339 is a first-in-class transferrin targeted small molecule that down-regulates GRP78, a key regulator of mis-folded protein processing and a tumor survival factor.

NKP-1339 Phase I Interim DataThe Phase I trial is conducted in patients with metastatic solid tumors resistant to standard therapies. Previous to enrollment in the trial, all patients had received multiple standard therapies and exhibited disease progression on their last treatment. Of the first 24 patients enrolled, six patients (25%) exhibited anti-tumor activity, demonstrated by disease stability and/or tumor regression for at least 12 weeks.

Of the responding six patients, one patient with carcinoid tumor, a non-pancreatic neuroendocrine tumor (non-pNET), has tumor regression and continues on NKP-1339 therapy for more than 70 weeks. The five other patients have experienced stable disease of up to 24 weeks with NKP-1339 treatment. These patients have the following tumor types: one gastrinoma non-pNET, one colorectal cancer, two non-small cell lung cancers and one cancer of unknown primary.

NKP-1339 treatment has been well tolerated to date with mild manageable side effects. The most common drug-related side effects are grade 1-2 fever and mild flu-like symptoms, which can be prevented with standard medications. The maximum tolerated dose has not been reached and NKP-1339 dose escalation continues.

The 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 (TGen), and Dr. Howard Burris, Director of Drug Development at the Sarah Cannon Research Institute (SCRI).

"We need new treatments for patients with non-pNET. The NKP-1339 anti-tumor activity observed in these two non-
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SOURCE Niiki Pharma Inc.
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