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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Aclaris Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Aclaris Therapeutics, 2018, MAR 12, 2018, View Source [SID1234524656]).

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20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

Hutchison China MediTech has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, Hutchison China MediTech, 2018, MAR 12, 2018, View Source [SID1234524655]).

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Lipocine has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Lipocine, 2018, MAR 12, 2018, View Source [SID1234524653]).

Journal of Clinical Oncology: Phase II Trial of Fruquintinib in Patients with Advanced Nonsquamous NSCLC

Patients with advanced non‒small-cell lung cancer (NSCLC) who fail two lines of chemotherapy have unmet medical needs (Press release, Hutchison China MediTech, MAR 12, 2018, https://www.chi-med.com/jco-phase-ii-fruquintinib-nsclc/ [SID1234525456]). The kinase inhibitor fruquintinib selectively targets vascular endothelial growth factor receptors and, hence, tumor angiogenesis and lymphogenesis. This randomized, double-blind, placebo-controlled, multicenter phase II trial evaluated the efficacy and safety of fruquintinib in patients with advanced nonsquamous NSCLC who experienced disease progression after second-line chemotherapy.

Patients and Methods
Eligible patients were randomly assigned (two to one; stratified by epidermal growth factor receptor status) to receive fruquintinib or placebo, both in combination with best supportive care. Oral fruquintinib (5 mg once daily) was given in 4-week cycles of 3 weeks of treatment followed by 1 week off. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors version 1.1. The primary end point was progression-free survival (PFS) evaluated by a blinded image central review (BICR) committee. Secondary end points included investigator-evaluated PFS, objective response rate, disease control rate, overall survival, and safety.

Results
Ninety-one patients from 12 hospitals received treatment with fruquintinib (n = 61) or placebo (n = 30). Median PFS was 3.8 months with fruquintinib by both BICR and investigators’ evaluations (hazard ratio by BICR, 0.34; 95% CI, 0.20 to 0.57; P < .001). Three- and 6-month survival rates were 90.2% and 67.2% in the fruquintinib group and 73.3% and 58.8% in the placebo group, respectively. The objective response rate and disease control rate were 13.1% and 60.7% with fruquintinib, compared with 0% and 13.3% with placebo (P = .041 and < .001), respectively. The most common treatment-emergent adverse events with fruquintinib (≥ grade 3) were hypertension (8.2%), hand-foot syndrome (4.9%), and proteinuria (4.9%).

Crinetics Pharmaceuticals Announces Upcoming Presentations at ENDO 2018

On March 12, 2018 Crinetics Pharmaceuticals, Inc., a rare disease therapeutics company focused on endocrine disorders and endocrine-related cancers, reported an oral presentation and two poster presentations relating to the company’s drug development candidates (Press release, Crinetics Pharmaceuticals, MAR 12, 2018, View Source [SID1234525096]). These presentations will be made at the upcoming ENDO 2018, the Annual Meeting of the Endocrine Society, taking place from March 17-20, 2018 in McCormick Place West, Chicago, Illinois.

Oral Presentation:

Title: Phase 1 Clinical Trial of CRN00808, an Orally Bioavailable sst2-Selective, Nonpeptide Somatostatin Biased Agonist for the Treatment of Acromegaly: Safety, Pharmacokinetics, and Inhibition of GHRH-Induced GH Secretion.
Session: OR06 – Pituitary Tumors: Acromegaly and Prolactinomas.
Poster: ORO6-3.
Date and Time: Saturday, March 17, 12-12:15 p.m. CDT
Location: W192.

Poster Presentations:

Title: Suppression of Growth Hormone and Insulin-Like Growth Factor 1 in Rats After Oral Administration of CRN00808, a Small Molecule, SST2 Selective Somatostatin Biased Agonist.
Session: P32 – Pituitary Transcription Factors and New Hormonal Signaling Pathways.
Poster: SUN-604.
Date and Time: Sunday, March 18, 1-3 p.m. CDT
Location: ENDOExpo, Hall F.

Title: Somatostatin Subtype 5 (sst5) Agonists for the Treatment of Hyperinsulinism: Orally-Bioavailable Small Molecules Suppress Insulin and Rescue Glyburide-Induced Hypoglycemia.
Session: P14-3 – Pediatric Endocrinology – Disorders of Sexual Differentiation, Transgender Medicine, Metabolic Disorders, and Growth.
Poster: MON-193.
Date and Time: Monday, March 19, 1-3 p.m. CDT
Location: ENDOExpo, Hall F.