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Old 02-10-2010, 10:42 PM   #1
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Arizona: CPI-613 trial (alpha lipoic analog)


Researchers seek cancer patients for clinical drug trial

Arizona cancer patients have an opportunity to participate in a new clinical drug trial of a medication geared to help those with solid tumors, such as those with breast, lung and prostate cancer.
The Peoria office of Pivotal Research Centers is one of three clinical trial sites in the world recruiting cancer patients to test the experimental cancer drug CPI-613.
"CPI-613 is a brand new anti-cancer drug that utilizes altered energy metabolism to attack cancer cells and hopefully doesnít disturb normal cells," said Dr. Divis Khaira, clinical trial investigator for Pivotal Research Center. "It is for patients who have failed other kinds of therapy, who have any kind of cancer, who have had other treatments that havenít worked."
"It seems Ö this drug actually works on patients who are resistant to other kinds of chemotherapy," Khaira said.
Dr. Robert Shorr, CEO for Cornerstone Pharmaceuticals, the manufacturer, said CPI-163 is part of a new chemical class of drugs that target metabolic changes that are common to many cancer types.
"CPI-613 shuts down mitochondrial ATP synthesis (the ability to turn food into energy) in cancer cells by attacking mitochondria," Shorr said. "Other drugs do not. Mitochondria is where energy is mostly produced in cells."
Khaira said Pivotal is recruiting those between ages 18 and 85 to take part in the trial.
Those who meet the criteria will be given the drug for the trial for as long as the patient responds, Khaira said. There will be no placebos used.
For information, call Pivotal Research at 1-866-788-3921.

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Old 07-20-2010, 02:24 AM   #2
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Re: Arizona: CPI-613 trial (alpha lipoic analog)

Phase 1 update: http://www.asco.org/ASCOv2/Meetings/...stractID=43689

Phase I trial of CPI-613, a lipoic acid analog, and gemcitabine in patients with advanced solid tumors.

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Phase I Studies

Developmental Therapeutics - Clinical Pharmacology and Immunotherapy

2010 ASCO Annual Meeting

Session Type and Session Title:
This abstract will not be presented at the 2010 ASCO Annual Meeting but has been published in conjunction with the meeting.

Abstract No:

J Clin Oncol 28, 2010 (suppl; abstr e13136)

A. S. Retter, R. Shorr, R. Rodriguez, K. Hoffman, F. Volterra, A. D. Hoffman, N. Huppert, K. Lee; Eastchester Center for Cancer Care, Bronx, NY; Cornerstone Pharmaceuticals, Cranbury, NJ
Background: Lipoic acid analogs are a novel class of anticancer agents that target the altered form of pyruvate dehydrogenase (PD) and possibly α-ketoglutarate dehydrogenase (KDH) causing a significant inhibition of mitochondrial energy metabolism selectively in tumor cells, leading to apoptosis. CPI-613 (C), a member of this novel class, has shown excellent toxicity and efficacy profiles in preclinical models. We initiated a phase I dose-escalation study utilizing the combination of (C) and gemcitabine (G) in patients with metastatic solid tumors. Methods: Patients were treated with (G) 1000 mg/m2 on days 1, 8, and 15 and (C) at escalating doses on days 1, 4, 8, 11, 15 and 18 of a 21-day cycle. Three cohorts of patients each with 3 patients received (C) at a dose of 21, 42, and 70 mg/m2 respectively. Intrapatient dose escalation was allowed and patients received from 1 to 5 cycles of treatment. Tumor types included breast, colon, and pancreas. Plasma concentrations of (C) were assayed using a validated Liquid Chromatography-Mass Spectroscopy method. Results: 9 patients have been treated to date and accrual is ongoing. No DLT has been seen through the first 3 cohorts. The only AE grade 3 or higher were hematologic and attributable to (G). MTD has not yet been reached. PK studies show that plasma (C) levels are appropriately dose-related and plasma half-life was approx 2-6 hours. Response assessments for 8 patients in the first 3 cohorts show 4 pts (tumor types breast and colon) with stable disease that ranged from 4 to 16 weeks in duration. PET imaging showed a reduction from 4-42% as well in FDG avidity. Conclusions: CPI-613 in combination with (G) appears to be well-tolerated with promising efficacy in patients with solid tumors.

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Old 07-20-2010, 07:46 PM   #3
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Re: Arizona: CPI-613 trial (alpha lipoic analog)

this is quite interestin; I've also read that alpha lipoic acid is invaluable in treating neuropathy; a side effect of herceptin. Has anyone else heard this and is there evidence?
thank you,
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