Novel First-in-Class Anti-Cancer Agent in Development by Niiki Pharma Shows Promising Phase I Results

By Niiki Pharma Inc., PRNE
Tuesday, May 31, 2011

HOBOKEN, New Jersey and PHILADELPHIA, June 1, 2011 -

- Phase I Data for NKP-1339, a First-in-Class Transferrin Targeted
Anti-Cancer Agent to be Presented at Upcoming American Society of Clinical
Oncology Annual Meeting

Niiki Pharma announced today that it will present interim data from the
ongoing Phase I clinical study for its lead product, NKP-1339, at the 2011
American Society for Clinical Oncology meeting in Chicago, IL. NKP-1339 is a
novel transferrin targeted ruthenium based anti-cancer compound. The
intracellular targets of NKP-1339 include GRP78, a key regulator of
mis-folded protein processing. In preclinical studies, in vivo and in vitro
activity has been demonstrated against multiple tumor types, including those
resistant to other anti-cancer agents.

The NKP-1339 Phase I trial is a dose-ascending trial and determines the
safety, tolerability, maximum tolerated dose (MTD) and pharmacokinetics of
NKP-1339. A total of 16 patients with metastatic solid tumors resistant to
standard therapies have been treated to date at six different dose levels.
NKP-1339 treatment has been generally well tolerated, with the most common
drug related side effects of grade 1-2 fever and mild flu-like symptoms. MTD
has not been reached and NKP-1339 dose escalation continues. Signs of
anti-tumor activity (stable disease greater than or equal to four months;
tumor regression) have been observed. A patient with a neuroendocrine tumor
(NET) of the small intestine has been on NKP-1339 therapy for over 13 months
with a continuing minor response. The patient remains on NKP-1339 therapy.
Another patient with the metastatic gastrinoma NET exhibited six months
stable disease, and two patients with metastatic non-small cell lung cancer
exhibited four months stable disease.

The NKP-1339 Phase I trial is being led by Dr. Daniel Von Hoff,
Translational Genomics Institute, Arizona, and Dr. Howard Burris, Sarah Canon
Research Institute, Tennessee. Reflecting on NKP-1339's novel mechanism of
action, Dr. Von Hoff noted "Resistance to anti-cancer therapy remains a major
challenge in treatment of patients with metastatic cancer. First-in-class
drugs, like NKP-1339, can take us one step further to address this high unmet
need." While Dr. Burris commented, "The results to date indicate that
NKP-1339 could be a promising new agent that would enhance our anti-cancer
armamentarium."

About Niiki Pharma

Niiki Pharma Inc. is an oncology therapeutics development company with a
pipeline of novel targeted anti-cancer agents. For more information, visit
www.niikipharma.com.

About Translational Genomics Institute

The Translational Genomics Research Institute (TGen) is dedicated to
conducting groundbreaking research with diseases such as cancer, neurological
disorders and diabetes. For more information, visit www.tgen.org .

About Sarah Canon Research Institute

Sarah Cannon Research Institute (SCRI) is a global clinical research
organization focusing on advancing therapies and accelerating drug
development in areas such as oncology, cardiology and gastroenterology. For
more information, visit sarahcannonresearch.com.

For media relations and other inquiries: Carolyn Rhinebarger, carolyn at luminovas.com, +1-919-604-4053; For investor relations: Ali Ardakani, ardakani at niikipharma.com, +1-201-238-2885

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