Approval of Phase I/II Clinical Trial of ATG-016 (Eltanexor), a Second Generation Selective Inhibitor of Nuclear Export (SINE), in Mainland China for the Treatment of Myelodysplastic Syndrome

Antengene Corporation Limited announced that the National Medical Products Administration has approved the clinical trial of ATG-016 in patients with intermediate and higher risk myelodysplastic syndrome according to the Revised International Prognostic Scoring System after the failure of hypomethylating agents based therapy. The trial is a Phase I/II, single-arm, open-label clinical study, aiming to evaluate the pharmacokinetics, safety and efficacy of ATG-016 monotherapy.
[Antengene Corporation Limited]
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Istari Oncology Announces First Patient Dosed in the LUMINOS-101 Phase II Clinical Trial of PVSRIPO in Combination with Pembrolizumab for Patients with Recurrent Glioblastoma

Istari Oncology, Inc. announced the first patient was dosed in the LUMINOS-101 Phase II clinical trial, assessing the safety and efficacy of PVSRIPO in combination with the immune checkpoint inhibitor pembrolizumab (Keytruda®) in patients with recurrent glioblastoma multiforme.
[Istari Oncology, Inc.]
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Genprex Initiates Site Recruitment for Acclaim-1 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer

Genprex, Inc. announced it has commenced clinical trial site recruitment for its upcoming Acclaim-1 clinical trial for the treatment of non-small cell lung cancer. Acclaim-1 is an open-label, multi-center Phase 1/2 clinical trial that combines Genprex’s lead drug candidate, REQORSA™ immunogene therapy with AstraZeneca PLC’s Tagrisso.
[Genprex, Inc.]
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PMV Pharma Doses First Patient in Phase I/II Study of PC14586, a First-in-Class Precision Oncology Therapy that Targets Mutant p53

PMV Pharmaceuticals, Inc. announced dosing of the first patient in its Phase I/II clinical trial evaluating PC14586, the company’s investigational lead compound that targets the Y220C mutant of p53.
[PMV Pharmaceuticals, Inc.]
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City of Hope Initiates Phase I Clinical Trial to Test Its First SARS-CoV-2 Investigational Vaccine

City of Hope has initiated a Phase I clinical trial that will test one of its investigational SARS-CoV-2 vaccines in healthy volunteers between the ages of 18 and 55 who have not had COVID-19.
[City of Hope]
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Phoenix Molecular Designs Announces First Patient Dosed in Phase 1b Clinical Trial of PMD-026 Taking Aim at Triple Negative Breast Cancer

Phoenix Molecular Designs announced that the first patient has been dosed in their Phase Ib clinical trial of PMD-026. This RSK targeting trial was a first of its kind in the battle to combat the most aggressive subtype of breast cancer, known as TNBC.
[Phoenix Molecular Designs (PR Newswire LLC)]
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Chiasma Announces Positive Topline Results from the MPOWERED™ Phase III Clinical Trial Comparing MYCAPSSA® (Octreotide Capsules) to Long Acting Injectables for the Maintenance Treatment of Adults with Acromegaly

Chiasma, Inc. announced positive top-line data from its global Phase III MPOWERED™ non-inferiority clinical trial comparing MYCAPSSA® to long-acting injectable somatostatin analogs for maintenance of biochemical response in patients with acromegaly.
[Chiasma, Inc.]
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Immunocore’s Tebentafusp Demonstrates Superior Overall Survival Compared to Investigator’s Choice in a Phase III Clinical Trial of Patients with Previously Untreated Metastatic Uveal Melanoma

Immunocore announced that its Phase III IMCgp100-202 clinical trial of tebentafusp vs. investigator choice in metastatic uveal melanoma has met the pre-defined boundaries for statistical significance of the primary endpoint of Overall Survival (OS) in its first pre-planned interim analysis conducted by the independent data monitoring committee.
[Immunocore]
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Helixmith Announces First Patient Enrolled in Phase III Study of Engensis

Helixmith announced enrollment of the first patient in a second Phase III clinical trial targeting diabetic peripheral neuropathy (DPN), REGAiN-1A, using Helixmith’s flagship gene therapy product Engensis REGAiN-1A has an initial target enrollment of 152 DPN patients at approximately 15 clinical sites across the US.
[Helixmith]
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Influence of Patient Characteristics on Chimeric Antigen Receptor T Cell Therapy in B-Cell Acute Lymphoblastic Leukemia

Investigators report the outcome of 51 r/r B-ALL patients from a non-randomized, Phase II clinical trial. The primary outcome showed that the overall remission rate was 80.9%.
[Nature Communications]
An, F., Wang, H., Liu, Z., Wu, F., Zhang, J., Tao, Q., Li, Y., Shen, Y., Ruan, Y., Zhang, Q., Pan, Y., Zhu, W., Qin, H., Wang, Y., Fu, Y., Feng, Z., & Zhai, Z. (2020). Influence of patient characteristics on chimeric antigen receptor T cell therapy in B-cell acute lymphoblastic leukemia. Nature Communications, 11(1), 5928. https://doi.org/10.1038/s41467-020-19774-x Cite
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Arcutis Announces Positive Topline Data from Phase IIb Study of ARQ-154 (Topical Roflumilast Foam) as a Potential Treatment for Scalp and Body Psoriasis

Arcutis Biotherapeutics, Inc. announced positive top line data from its Phase IIb clinical trial evaluating ARQ-154 (topical roflumilast foam) as a potential treatment for scalp psoriasis. Roflumilast foam demonstrated statistically significant improvement on the trial’s primary and multiple secondary endpoints.
[Arcutis Biotherapeutics, Inc.]
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