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A Clinical Study Shows the Theracurmin®’s Safety and Potential Role in Improving Quality of Life (QOL) of Pancreatic Cancer Patients

2013年05月10日 AM03:10
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TOKYO

Theravalues, Japan-based biotechnology innovator, announced today that a recent phase I clinical trial on the pancreatic cancer patients using Theracurmin®, an enhanced form of curcumin that allows for greater absorption, has no adverse effect for both of dose levels (200mg/day and 400mg/day) on cancer patients. The study also discovered that the Theracurmin® dosage helped improve a whole range of Quality of Life (QOL) scores of the patients.

In 2012, the group led by Dr. Masashi Kanai, Outpatient Oncology Unit, Kyoto University Hospital conducted a phase I study to look into the dosage effects of the Theracurmin® over 14 pancreatic and 2 biliary tract cancer patients who failed standard chemotherapy, but were still on standard gemcitabine-based regimens. The results of the study were published in “Cancer Chemother Phamacol” online on March 30, 2013*.

The key findings of the study are as follows:

  • Overall, Theracurmin® did not increase the risk of adverse events on 16 advanced pancreatic or biliary tract cancer patients receiving palliative chemotherapy even at relatively high dosage levels. (200mg/day and 400 mg/day as curcumin)
  • Theracurmin® administration produced significant high blood concentrations in a dose dependent fashion, proving its high absorption capabilities. The median plasma curcumin level 2 hours after Theracurmin® intake were significantly higher than the median value of the previous study, using 8 g of conventional curcumin.
  • Theracurmin® administration demonstrated considerable improvement of QOL scores, including fatigue score, functional (emotional, role, cognitive, physical, and social functions) score, and appetite loss score.
  • The median survival time (MST) was 132 days and three patients (21%) survived more than 12 months. Given that dismal prognosis of patients enrolled in this study, these results are quite promising.

“While we believed the efficacy of the curcumin from various preclinical studies for its anticancer potentiality, there was few clinical trials testing this hypothesis due to the low bioavailability of the conventional curcumin, remaining the safety of repetitive systemic exposure to high concentration of curcumin to be clarified, ” said Dr. Kanai, at Kyoto University who lead this study. Theracurmin®, developed by Theravalues, with its sub-micron particles and surface-control technologies, enhanced the absorption of the curcumin and enabled the team to conduct such high concentration intake of the curcumin on the patients. “We are pleased with the results of our phase I study where we could prove curcumin’s positive impacts on pancreatic and biliary tract cancer patients without increasing the risk of severe adverse events. ”

Tadashi Hashimoto, President of Theravalues, said, “We find the results of the study conducted by Dr. Kanai and his team who found no significant adverse effect of usage of Theracurmin® of which versatility is proven or being proven by various past and on-going studies, very encouraging. I am particularly excited to learn that Theracurmin® has significant positive impact in improving QOL of the pancreatic or biliary patients and their families given that the terminal stage of these illnesses is usually intolerable. ”

The group plans to start Multi-center Phase II Clinical Trial (a double blind randomized control study) for the pancreatic cancer patients by this summer.

*Link to the paper: http://www.ncbi.nlm.nih.gov/pubmed/23543271

ABOUT THERAVALUES CORPORATION

Founded in 2007, Japan-based Theravalues Corporation strives to foster better physical and mental health to ensure a high-level of global customer satisfaction. Theravalues creates value through its innovative technologies, and development of foods, medicines and technological models that achieve and sustain wellness for all. To learn more, visit www.theravalues.com/english.

CONTACT

Theravalues, Japan
Masami Hasegawa, +81.3.3234.7677
mhasegawa@theravalues.com

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