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Interleukin-12 (IL-12) is a potent immunopotentiator of T-cell function, and has been shown in phase I clinical trials to be tolerable.
Clinically meaningful antitumor activity, symptom relief, and a good tolerability profile have been shown in phase II trials of gefitinib monotherapy in patients with recurrent non-small cell lung cancer.
Good safety profiles have been shown in phase 1 trials on healthy previously BCG vaccinated adults.
Docetaxel has been shown, in phase II studies, to induce responses in over 50% of patients with anthracycline-resistant breast cancer [ 14].
The tyrosine kinase inhibitor Iressa (ZD 1839, gefitinib) was developed mainly for the treatment of advanced lung cancers but has been shown in phase I/II trials to have potential benefits in other solid tumors, including breast cancer.
53, 57 The investigational integrase inhibitor dolutegravir (formerly known as S/GSK1349572, Shionogi/Glaxo Smith Kline) has been shown in phase I/II trials to have excellent activity in antiretroviral-naïve HIV-infected patients.
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Radium-223 is the first alpha-emitting radiopharmaceutical to reach clinical trials and has been shown in phases I and II trials to improve survival in patients with skeletal metastases from prostate cancer [38].
The prophylactic quadrivalent HPV vaccine, was shown in phase 3 trials to be almost 100% effective for vaccine-related HPV types in preventing their respective related disease, including genital warts, cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN) in young women naïve to these HPV types targeted by the vaccine [ 6- 8].
The efficacy of abatacept monotherapy has been shown in a phase IIa trial in patients with RA with an inadequate response to disease-modifying anti-rheumatic drugs (DMARDs).
Similar results, using RT and TMZ, have been shown in other phase II trials with 2-year survival ranging from 29%to38%8% [ 26– 30].
In addition, good tolerance of rectally applied EcN was already been shown in a phase-I study involving 80 patients (data on file at Ardeypharm).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com