On Wednesday, Shares of Eleven Biotherapeutics Inc (NASDAQ:EBIO), gained 74.79% to $4.09.
Eleven Biotherapeutics, declared dose administration for the first patients in a Phase 3 study of EBI-005 for the treatment of moderate to severe allergic conjunctivitis. This Phase 3 study was designed and initiated following the completion in October 2014 of a Phase 2 study in which EBI-005 exhibited biological activity in improving the symptoms of late-phase allergic responses in patients with moderate to severe allergic conjunctivitis. This comprised of statistically noteworthy improvements in mean change from baseline in patient stated ocular itching, tearing and associated nasal symptoms contrast to vehicle-control at the second to last and final assessment time points following allergen exposure in a modified direct conjunctival allergen provocation test (CAPT) model.
“Patient dosing in this Phase 3 study represents a noteworthy step forward in the clinical development of EBI-005, a drug candidate with potential for the treatment of moderate to severe allergic conjunctivitis patients who are refractory to standard of care treatments for ocular allergy,” said Abbie Celniker, PhD, Chief Executive Officer of Eleven Biotherapeutics. “We look forward to reporting top line data from this Phase 3 study in the first quarter of 2016.”
This multi-center, double-masked, randomized, vehicle controlled Phase 3 pivotal trial is designed to evaluate the safety and efficacy of EBI-005 for up to four weeks in patients with moderate to severe allergic conjunctivitis in an environmental setting. About 250 patients will be randomized 1:1 to receive treatment with EBI-005 or with vehicle. If the results of this first Phase 3 trial are favorable, Eleven intends to initiate a second Phase 3 trial in the second half of 2016.
Eleven Biotherapeutics, Inc., a clinical-stage biopharmaceutical company, engages in the discovery and development of protein therapeutics to treat eye diseases primarily in the United States.
Shares of Threshold Pharmaceuticals, Inc. (NASDAQ:THLD), inclined 4.31% to $4.36, during its last trading session.
Threshold Pharmaceuticals, declared that the company, in partnership with the Academic Thoracic Oncology Medical Investigators Consortium (ATOMIC), has initiated the first Phase 2 clinical trial of tarloxotinib bromide, or “tarloxotinib” (TH-4000), for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been formerly treated with an EGFR tyrosine kinase inhibitor and are progressing on treatment, but have not attained the T790M resistance mutation. Tarloxotinib is Threshold’s proprietary, hypoxia-activated, irreversible EGFR tyrosine kinase inhibitor licensed from the University of Auckland, New Zealand.
Aberrant EGFR signaling is implicated in the growth and spread of certain tumor types counting NSCLC. The majority of patients with EGFR-mutant NSCLC who are treated with a presently accessible EGFR tyrosine kinase inhibitor, such as Tarceva (erlotinib), Gilotrif (afatinib) and Iressa (gefitinib), will develop resistance, due to a variety of mechanisms, to these targeted therapies in about a year.
The Phase 2 clinical trial is a single-arm, open label study that will enroll up to 37 patients with Stage IV NSCLC who have a sensitizing EGFR mutation and who have progressed on EGFR tyrosine kinase inhibitor therapy (with no intervening therapy), and who subsequently test negative for the T790M mutation on post-progression biopsy. Eligible patients will receive tarloxotinib (150 mg/m2 by intravenous infusion) on Days 1, 8, 15 and 22 of a 28-day cycle. RECIST response rate is the primary endpoint. Secondary endpoints comprise duration of response, progression-free survival, overall survival, safety, tolerability and pharmacokinetics. In addition to other target-specific biomarkers, hypoxia status will be measured at baseline using Threshold’s proprietary PET imaging agent [18F]-HX4. The study will be open at 12 sites in the U.S. and Australia.
Threshold Pharmaceuticals, Inc., a biotechnology company, discovers and develops therapeutic agents that target tumor cells for the treatment of patients living with cancer in the United States.
Finally, American Campus Communities, Inc. (NYSE:ACC), ended its last trade with 0.22% gain, and closed at $37.24.
American Campus Communities declared that the company’s independent, non-executive Chairman of the Board, R.D. Burck, is temporarily relinquishing his chairman duties in order to focus on recovering from a recently-diagnosed illness. Mr. Burck will remain a member of the Board of Directors. Effective right away, the Board has designated Edward Lowenthal, a longstanding member of the Board and Chair of the Corporate Governance and Nominating Committee, to serve as the acting independent, non-executive Chairman of the Board during Mr. Burck’s absence.
“Dan Burck brings a wealth of knowledge and experience to ACC that has greatly benefited our shareholders whom he represents, the board as a whole, and our executive team,” said Bill Bayless, American Campus CEO. “Since our IPO in 2004, Dan has served as a mentor and role model for me and the entire American Campus executive team. We are all grateful for the constructive insight and guidance he has offered on behalf of our shareholders. All of us at ACC wish Dan a fast and full recovery and look forward to him returning to his Chairman role in the near future.”
American Campus Communities, Inc. is an independent equity real estate investment trust. The firm invests in the real estate markets of the United States. It primarily engages in developing, owning, and managing high-quality student housing communities.
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