Arrowhead (ARWR) Doses First Patient in Phase 1 Trial with Adipotide
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Arrowhead Research Corporation (NASDAQ: ARWR) today announced that the first patient has been dosed in a Phase 1 clinical trial with Adipotide®, a new class of treatment for obesity. Adipotide, formerly known as Prohibitin-TP01, is a synthetic peptide that targets a protein on the surface of blood vessels supporting white adipose tissue (fat), disrupting the blood supply to fat cells and causing them to be reabsorbed and metabolized. Treatment has led to substantial weight loss, decreased food intake, and rapid metabolic changes with implications for Type II diabetes in multiple experimental animal models.
The Phase 1 trial is designed to evaluate a single 28 day cycle of Adipotide in patients with castrate-resistant prostate cancer and no standard treatment options. The study is intended to identify a maximum tolerated dose, assess pharmacokinetics, measure the change in weight, and monitor disease progression, in addition to other secondary outcome measures. Fat tissue is known to produce substances that can promote prostate cancer growth. Investigators at the MD Anderson Cancer Center, who are conducting and bearing the costs of the clinical trial, also seek to learn if decreasing white fat, the type of fat associated with obesity, can slow the growth of prostate cancer.
Patients will receive Adipotide as an injection under the skin once daily for 28 days. Up to five dose levels will be tested with three participants enrolled at each dose level. The first group will receive the lowest dose and each new group will receive a higher dose level than the group before it, based on an evaluation of observed safety. This will continue until the highest dose of Adipotide with acceptable safety is found or all five dosing cohorts have been completed.
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The Phase 1 trial is designed to evaluate a single 28 day cycle of Adipotide in patients with castrate-resistant prostate cancer and no standard treatment options. The study is intended to identify a maximum tolerated dose, assess pharmacokinetics, measure the change in weight, and monitor disease progression, in addition to other secondary outcome measures. Fat tissue is known to produce substances that can promote prostate cancer growth. Investigators at the MD Anderson Cancer Center, who are conducting and bearing the costs of the clinical trial, also seek to learn if decreasing white fat, the type of fat associated with obesity, can slow the growth of prostate cancer.
Patients will receive Adipotide as an injection under the skin once daily for 28 days. Up to five dose levels will be tested with three participants enrolled at each dose level. The first group will receive the lowest dose and each new group will receive a higher dose level than the group before it, based on an evaluation of observed safety. This will continue until the highest dose of Adipotide with acceptable safety is found or all five dosing cohorts have been completed.
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