Imugene draws up protocol for HER-Vaxx trial
Imugene (ASX:IMU) has finalised the protocol for a phase Ib/II trial of HER-Vaxx in gastric cancer due to commence in the first half of this year.
The randomised, double-blind, placebo-controlled trial will compare HER-Vaxx in combination with cisplatin with capecitabine or 5-fluorouracil chemotherapy in patients with metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction.
Imugene has also appointed US nonclinical CRO WIL Research to conduct preclinical studies to support an Investigational New Drug (IND) application with the US FDA. Imugene commenced the IND process in March.
WIL Research provides discovery support services, product safety toxicological research, analytical chemistry and formulation services. It has offices in the US, the Netherlands, France and Japan.
“This represents another milestone passed and emphasises Imugene’s focus to conduct the kind of efficient, high-quality phase II trial that pharmaceutical companies prefer to see,” Imugene CEO Charles Walker said.
“The next step is to appoint an internationally regarded CRO in 1H 2015 to efficiently manage the clinical trial. The trial remains on track to start in the second half of next year.”
In December, Imugene completed a $3.5 million capital raising to help fund the trial.
Imugene (ASX:IMU) shares were trading 22.22% higher at $0.011 as of around 1.30 pm on Tuesday.
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