Navigation Links
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 in this advanced cancer patient population shows evidence of activity in patients with NET, " commented Dr. Von Hoff.

"We are excited with the prospects for NKP-1339 in NET, an orphan indication which is presently highly underserved. NKP-1339 trials in this indication are in development. In addition the favorable NKP-1339 safety profile supports plans to evaluate NKP-1339 in combination regimens in other tumor types," said Angela Ogden, M.D., Chief Medical Officer at Niiki Pharma.

About NKP-1339

NKP-1339 is a first-in-class small molecule anti-cancer compound. NKP-1339 down-regulates GRP78, a key regulator of mis-folded protein processing and a tumor survival and anti-apoptosis factor. Up-regulation of GRP78 is associated with intrinsic and chemotherapy-induced resistance in many tumor types. In preclinical studies, NKP-1339 has demonstrated activity against multiple tumor types, including those resistant to other anti-cancer agents. NKP-1339 was discovered by Professor Bernhard Keppler, University of Vienna, Austria.

About Niiki Pharma Inc.

Niiki Pharma (www.niikipharma.com) is a development focused oncology company specializing in first-in-class cancer treatments directed at novel tumor targets and related companion diagnostics.


'/>"/>
SOURCE Niiki Pharma Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Novel First-in-Class Anti-Cancer Agent in Development by Niiki Pharma Shows Promising Phase I Results
2. Niiki Pharma Announces Positive Interim Data from Ongoing Clinical Trial of Novel Anti-Cancer Agent NKP-1339
3. Niiki Pharma Reports on Synergistic Activity of Novel Anti-Cancer Agent NKP-1339 with Other Anti-Cancer Agents
4. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
5. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
6. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
7. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
8. Clinical Trial Effectiveness: How Pharmas & Biotechs Save Cost with Savvy Investigator Management
9. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
10. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
11. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... 24, 2016 Dutch surgeons have launched a ... the world and treat patients on a global scale. Medical professionals ... Asia and the US have already signed ... and networking in a totally secure environment. Education  ... zone working together with a surgeon at Harvard to treat a ...
(Date:5/23/2016)... , May 23, 2016 Global ... 163 pages, profiles 12 companies and the Paclitaxel analysis ... figures on the industry and its players. ... comprehensive in nature, details the current state of the ... including definitions, classifications, applications and industry chain structure. The ...
(Date:5/23/2016)... , May 23, 2016 ... Size, Share, Development, Growth and Demand Forecast to ... and Other), by Application (Drug Discovery and Development, ... Users (Pharmaceuticals, Life Science and Biotechnology, Academic and ... Market Research, the global mass spectrometry market ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... May 26, 2016 , ... With long-term experience in ... of Business Intelligence and Informatics, effective immediately. http://www.fluidedgeconsulting.com , As a ... a healthcare business and financial strategist for over 20 years. By leveraging ...
(Date:5/25/2016)... (PRWEB) , ... May 26, 2016 , ... The United ... treatment of androgenetic alopecia in both men and women. To date, the company is ... with FDA clearance for any adult who suffers with androgenetic alopecia. , “This ...
(Date:5/25/2016)... ... May 25, 2016 , ... ... Association's Get With The Guidelines®-Stroke Gold Plus Achievement Award with Target: StrokeSM ... Memorial Healthcare System, recognizes its commitment to emergency stroke care to ensure ...
(Date:5/25/2016)... ... May 25, 2016 , ... ... and Tennessee locations to streamline patient check-in and post visit surveys. , “The ... to patient care. It has revolutionized the check-in process for our clinic network, ...
(Date:5/25/2016)... ... May 25, 2016 , ... Furthering its position as the industry leader in ... Drug Free Sport (Drug Free Sport®) is excited to expand on details of its ... 12 – 13 in Kansas City, MO, will gather sports industry professionals to examine, ...
Breaking Medicine News(10 mins):