Can-Fite BioPharma provided an update on its Phase II clinical trial of drug candidate Namodenoson, or CF102, for the treatment of advanced hepatocellular carcinoma, or HCC, in patients whose disease has progressed on sorafenib therapy. Top line efficacy results are expected by end of year. The global Phase II study is being conducted in the U.S., Europe and Israel.
https://thefly.com/landingPageNews.php?id=2785007
Tuesday, September 4, 2018
RedHill Biopharma reports completion of enrollment for Phase III Talicia study
RedHill Biopharma announced that the last patient was enrolled in the confirmatory Phase III study with TALICIA 1 for H. pylori infection. Top-line results from the study are expected to be announced before year’s end.If successful, and subject to additional regulatory feedback, the ERADICATE Hp2 study is expected to complete the package required to file a New Drug Application with the U.S. FDA for TALICIA in early 2019. TALICIA was granted Qualified Infectious Disease Product designation by the FDA, providing Fast-Track Development, six months priority NDA review and eight years of U.S. market exclusivity. TALICIA is intended to be the first product to be indicated for the treatment of H. pylori infection, regardless of ulcer status. The two-arm, randomized, double-blind, active comparator confirmatory Phase III study compares TALICIA against a dual therapy amoxicillin and omeprazole regimen at equivalent doses. The study enrolled 455 non-investigated dyspepsia patients with confirmed H. pylori infection in 55 clinical sites across the U.S. Subjects were randomized in a 1:1 ratio to receive four capsules, three times daily, of either TALICIA or the active comparator, for a period of 14 days. Subjects are being assessed for the study’s primary endpoint of eradication of H. pylori infection at 43 through 71 days after initiation of treatment. The first Phase III study with TALICIA successfully met its primary endpoint of superiority over historical standard-of-care eradication rate of 70%, with high statistical significance. The study results demonstrated 89.4% efficacy in eradicating H. pylori infection with TALICIA. Notably, these results were also superior to subsequent open-label treatment with SoC therapies of patients in the placebo arm of the ERADICATE Hp study, which demonstrated 63% eradication rate, further supporting the potential efficacy of TALICIA. Treatment with TALICIA was shown to be safe and well tolerated.
Rigel Pharmaceuticals price target raised to $7 from $6 at JPMorgan
JPMorgan analyst Anupam Rama raised his price target for Rigel Pharmaceuticals to $7 and reiterates an Overweight rating on the shares. The Tavalisse launch in chronic immune thrombocytopenia, progress on the follow-on indication of autoimmune hemolytic anemia, and potential outside the U.S. partnership progress should drive upside near- and long-term, Rama tells investors in a research note.
BioCryst: 750mg dose of BCX7353 ‘superior’ to placebo in Zenith-1 trial
BioCryst Pharmaceuticals announced initial results from the ZENITH-1 trial showing that a single 750 mg oral dose of BCX7353 was well tolerated and superior to placebo against the majority of efficacy endpoints evaluated in HAE patients suffering an acute attack. BCX7353 is a novel oral plasma kallikrein inhibitor being developed for both prophylactic and acute treatment of HAE attacks. In the 750 mg dose cohort of the trial, which has completed, 33 patients treated a total of 95 attacks. Patients self-treated their HAE attacks on a blinded basis with oral BCX7353 or oral placebo and recorded their symptoms and attack severity using both a Visual Analog Scale and a standardized questionnaire. Patients also recorded the time they used any standard-of-care acute treatment medicine. BCX7353 was superior to placebo for multiple clinical outcomes. Results from the ongoing evaluation of the 250 mg and 500 mg dose levels of oral BCX7353 in ZENITH-1 are expected in the first quarter of 2019.
Dynava publishes preclinical study of lung cancer immunogen
Dynavax Technologies announced publication of a preclinical study demonstrating that inhalation of a TLR9 agonist can stimulate effective immunity against lung tumors and complement the actions of PD-1 blockade to generate durable, systemic anti-tumor immunity. The paper titled Inhaled TLR9 Agonist Renders Lung Tumors Permissive to PD-1 Blockade by Promoting Optimal CD4+ and CD8+ T cell Interplay, by Dynavax scientists M.Gallotta, H. Assi, E. Degagne, S. Kannan, R.Coffman and C. Guiducci was published in the journal Cancer Research. The study demonstrated that combining an inhaled TLR9 agonist with systemic anti-PD-1 led to long-term survival in two different mouse lung tumor models, mediated by systemic immunity that eradicated tumors both in the lung and in distal organs. The study further delineated the distinctive mechanisms of action of these agents in the lung environment.
Apellis provides update on blood disorder med trial
Apellis announced an update on its US-based Phase 1b PHAROAH trial for patients with paroxysmal nocturnal hemoglobinuria, or PNH. The ongoing PHAROAH trial is evaluating treatment with APL-2, a novel inhibitor of complement factor C3, in patients on treatment with eculizumab who are severely anemic and transfusion-dependent. Patients enrolled in the PHAROAH trial were initially co-treated with APL-2 and eculizumab, with the potential for discontinuation of eculizumab at the discretion of the treating physician. Two of the six patients were removed from treatment with APL-2 due to pregnancy and BMI-associated comorbidities. Four of the six patients continued in the study for more than 32 weeks. In these four patients, co-treatment with APL-2 resulted in an improvement of hemoglobin levels and other markers for anemia and none of the four patients required a transfusion during the co-treatment period with eculizumab, which ranged from 17 to 20 months. Earlier this year Apellis announced that three of the four patients discontinued treatment with eculizumab and were continuing to receive APL-2. The fourth patient has now discontinued treatment with eculizumab and is continuing to receive APL-2. All four patients have improved hemoglobin and reticulocytes as compared to the baseline established with eculizumab monotherapy and have achieved lactate dehydrogenase levels below the upper limit of normal.
Shire downgraded to Market Perform as spread narrows at Bernstein
Bernstein analyst Aaron Gal downgraded Shire (SHPG) to Market Perform from Outperform. The analyst notes that he current controversy on Shire is the risk/reward into the closing of the Takeda (TKPYY) acquisition, and over the past few weeks deal spread narrowed, and the fundamentals have gotten a bit tougher in ADHD, HAE and Hemophilia.
https://thefly.com/landingPageNews.php?id=2785113
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