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Immutep Ltd (ASX:IMM) has dosed the first patient of its Phase 3 TACTI-004 non-small cell lung cancer trial – the final stage of clinical study before the company eventually takes final efficacy results to regulators.
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That’ll eventually include the FDA, given Immutep’s dual Australia-U.S. share listing, where the company sits on the NASDAQ.
But first, the company needs to prove to Australia’s TGA its drugs are effective.
“Trial results will inform potential marketing approval application in non-small cell lung cancer, one of the largest indications in oncology,” the company said.
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer affecting the tissues of the organs themselves. Ultimately, all three dominant types of NSCLC are carcinomas.
The globally-spanning trial set to eventually recruit 760 patients will evaluate Immutep’s drug eftilagimod alpha in conjunction with existing chemotherapy drugs against a group of patients only taking the chemotherapy drugs.
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“Dosing the first patient in our pivotal Phase III trial ranks among the most significant milestones in the Company’s history. We are excited about the potential of the TACTI- 004 study to deliver a new standard-of-care therapy,” Immutep CEO Mark Voigt said.
Let’s just hope the company has a better run than Opthea on Monday.
IMM last traded at 29cps.
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