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- Posted Tuesday April 9, 2013
TGen-Scottsdale Healthcare clinical trial finds new class of cancer drugs are safe and effective
Study of RNA interference drug presented at AACR Annual Meeting 2013
SCOTTSDALE, Ariz. - April 9, 2013 - The safety
and preliminary efficacy of a new class of tumor fighting drugs
were reported today by Scottsdale Healthcare's Virginia G. Piper
Cancer Center Clinical Trials and the Translational Genomics
Research Institute (TGen).
Early results from the phase I, first in-human study of an RNA
interference (RNAi) drug were announced during the American
Association for Cancer Research (AACR) Annual Meeting 2013, April
6-10, in Washington, D.C. The drug, TKM-080301 (also known as
TKM-PLK1) is being developed by Tekmira Pharmaceuticals
Corporation.
The study was conducted at Virginia G. Piper Cancer Center
Clinical Trials at Scottsdale Healthcare, a partnership with TGen.
It found that the RNAi drug acts by silencing the PLK1 gene
involved in tumor growth and can be safely administered in
humans. Most patients tolerated the drug well; some showed
therapeutic benefit.
"RNAi therapies are a unique approach to cancer treatment as they
have the potential to 'turn off' the genes' coding for proteins
involved in cancer cell division," said Dr. Ramesh K. Ramanathan,
Medical Director of Virginia G. Piper Cancer Center Clinical Trials
at Scottsdale Healthcare and deputy director of the Clinical
Translational Research Division of TGen. "Using a lipid
nanoparticle, the RNAi drug can be delivered to a cancer cell to
block the expression of specific proteins involved in tumor
growth."
TKM-080301 targets a specific gene called polo-like kinase 1
(PLK1), which codes for a protein involved in tumor cell growth.
Prior research has shown that high levels of PLK1 are present in
many types of cancer, including many of the more aggressive
forms.
"Our preclinical results have shown that by decreasing PLK1 levels
in cancer cells, we can stop tumor growth and kill the cancer
cells," Dr. Ramanathan said.
He and his colleagues have been enrolling patients with advanced
solid tumors or lymphoma into the ongoing multicenter, open-label,
dose-escalation study. Sequential cohorts of three to six patients
have been assigned to escalating doses of TKM-080301 as a 30-minute
intravenous infusion. To date, the researchers have assigned 23
patients to the drug at doses ranging from 0.15 mg/kg per week to
0.9 mg/kg per week.
The most common drug-related adverse events have been mild to
moderate and include fever, chills, nausea, vomiting and fatigue.
Dose-limiting toxicities were observed at the 0.9 mg/kg per-week
dose. One patient with a history of asthma experienced shortness of
breath and hypoxia; another patient had thrombocytopenia. The
researchers subsequently reduced the maximum dose to 0.75 mg/kg per
week.
Two patients have been assigned to TKM-080301 for more than six
months and have shown no evidence of cumulative toxicity. One of
these patients has stable disease and the other has a durable
confirmed partial response.
"RNAi therapies, such as the one used in our study, have the
potential to make a significant and broad impact on how we treat
cancer because we have the ability to target virtually any protein
involved in the disease," Ramanathan said. "This approach has the
potential to augment the currently available cancer treatments to
improve outcomes for the patient."
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About the Virginia G. Piper Cancer Center at Scottsdale
Healthcare
The Virginia G. Piper Cancer Center at Scottsdale Healthcare in
Scottsdale, Ariz. offers comprehensive cancer treatment and
research through clinical trials, diagnosis, treatment, prevention
and support services in collaboration with leading scientific
researchers and community oncologists. Scottsdale Healthcare is the
nonprofit parent organization of the Virginia G. Piper Cancer
Center at Scottsdale Healthcare, Scottsdale Healthcare Research
Institute, Scottsdale Healthcare Osborn Medical Center, Scottsdale
Healthcare Shea Medical Center and Scottsdale Healthcare Thompson
Peak Hospital. For more information, visit www.shc.org.
Media Contact:
Jamie Grim
Public Relations, Virginia G. Piper Cancer Center
480-323-1387
[email protected]
*
About TGen
The Translational Genomics Research Institute (TGen) is a Phoenix,
Arizona-based non-profit organization dedicated to conducting
groundbreaking research with life changing results. Research at
TGen is focused on helping patients with diseases such as cancer,
neurological disorders and diabetes. TGen is on the cutting edge of
translational research where investigators are able to unravel the
genetic components of common and complex diseases. Working with
collaborators in the scientific and medical communities, TGen
believes it can make a substantial contribution to the efficiency
and effectiveness of the translational process. For more
information, visit: www.tgen.org.
Media Contact:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
[email protected]
*
About the American Association for Cancer
Research
Founded in 1907, the American Association for Cancer Research
(AACR) is the world's first and largest professional organization
dedicated to advancing cancer research and its mission to prevent
and cure cancer. AACR membership includes more than 34,000
laboratory, translational and clinical researchers; population
scientists; other health care professionals; and cancer advocates
residing in more than 90 countries. The AACR marshals the full
spectrum of expertise of the cancer community to accelerate
progress in the prevention, biology, diagnosis and treatment of
cancer by annually convening more than 20 conferences and
educational workshops, the largest of which is the AACR Annual
Meeting with more than 17,000 attendees. In addition, the AACR
publishes eight peer-reviewed scientific journals and a magazine
for cancer survivors, patients and their caregivers. The AACR funds
meritorious research directly as well as in cooperation with
numerous cancer organizations. As the scientific partner of Stand
Up To Cancer, the AACR provides expert peer review, grants
administration and scientific oversight of team science and
individual grants in cancer research that have the potential for
near-term patient benefit. The AACR actively communicates with
legislators and policymakers about the value of cancer research and
related biomedical science in saving lives from cancer. For more
information about the AACR, visit www.AACR.org.