BeyondSpring announced that the Phase 3 portion of its pivotal Study 105, evaluating its lead asset, Plinabulin, in the 105 enrolled patients treated with docetaxel chemotherapy, has met its primary endpoint of non-inferiority versus Neulasta for the duration of severe neutropenia, or DSN, of the first cycle, with statistical significance in a pre-specified interim analysis. In this trial, Plinabulin as a single agent was compared head-to-head with Neulasta as a single agent. Based on the results from this Phase 3 trial, as well as the top line data from the Phase 2 portion of Study 106 released at the recent American Society of Hematology, or ASH, BeyondSpring now has the necessary data to submit a new drug application, or NDA, to the China FDA, or National Medical Products Administration, or NMPA, for the use of Plinabulin for the treatment of chemotherapy-induced neutropenia, or CIN. The company is also on track to submit an NDA to the U.S. FDA for the treatment of CIN. Both submissions will be for broad claims for the treatment of CIN in terms of type of chemotherapy as well as cancer type. The double-blind, randomized Phase 3 portion of Study 105 was to enroll approximately 150 patients in the U.S., Europe and China with advanced breast cancer, hormone refractory prostate cancer and advanced non-small cell lung cancer, or NSCLC, who were randomized to receive docetaxel, with either Plinabulin at a fixed dose of 40 mg on Day 1, or pegfilgrastim at 6 mg on Day 2 of each 21-day treatment cycle. Plinabulin is administered on the same day of chemotherapy, 30 minutes after chemo administration. Neutrophil count and other hematological parameters were evaluated by Covance Central Laboratory. Covance is also the global clinical CRO for the study for patient enrollment. The primary endpoint of the study was the DSN in the first cycle. A pre-specified interim analysis following approximately 100 patients enrolled was built into the protocol study design to evaluate the primary endpoint of non-inferiority for DSN versus Neulasta.
Thursday, December 6, 2018
Wave Life Sciences announces results from WVE-210201 trial
Wave Life Sciences announced that the safety and tolerability data from the WVE-210201 Phase 1 clinical trial in boys with Duchenne muscular dystrophy, or DMD, who are amenable to exon 51 skipping support initiation of a Phase 2/3 clinical trial. Based on results from four ascending dose cohorts in the Phase 1 trial and pending final analysis, Wave has selected a dose for its planned Phase 2/3 clinical trial of WVE-210201, which it intends to initiate in 2019. In parallel, the independent Safety Monitoring Committee of the Phase 1 clinical trial has endorsed moving forward with a higher dose of WVE-210201 to be studied in a fifth cohort. Wave plans to present the results from the WVE-210201 Phase 1 clinical trial, as well as details of the Phase 2/3 study design, at upcoming scientific meetings. Wave anticipates initiating a global, placebo-controlled Phase 2/3 efficacy and safety clinical trial of WVE-210201 in DMD patients amenable to exon 51 skipping in 2019. The Phase 2/3 trial is designed to measure clinical efficacy and dystrophin expression, and the company intends to use the results of this trial to seek regulatory approvals globally.
Evolent Health 2019 consensus revenue estimate ‘within reach,’ says Jefferies
After having dinner with CFO Nicky McGrane, Jefferies analyst Sean Dodge believes the current $860M 2019 Street revenue estimate for Evolent Health “is within reach.” This remains the primary focus of investors, Dodge tells investors in a research note. While admitting visibility isn’t 100% yet, the analyst reiterates a Buy rating on Evolent with a $30 price target.
Ovid Therapeutics to move into Phase 3 OV101 trial in pediatric patients
Ovid Therapeutics announced plans to move ahead with a single pivotal Phase 3 trial of OV101 in pediatric patients with Angelman syndrome based on its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration. If successful, the Phase 3 efficacy and safety trial called NEPTUNE is intended to support a New Drug Application for OV101 in Angelman syndrome. OV101 is a novel delta-selective GABAA receptor agonist. Based upon review and discussion of the Phase 2 STARS trial results, the clinical trial design, and the applicability of Clinical Global Impressions of Improvement (CGI-I) as a primary endpoint, the FDA and Ovid are in general agreement that the pivotal Phase 3 NEPTUNE clinical trial to be completed prior to an NDA submission, will include the following elements: Single 12-week, two-arm, randomized, double-blind, placebo-controlled trial; Once-daily dose; Approximately 50-60 pediatric patients aged 4 to 12 years, diagnosed with Angelman syndrome randomized to either placebo or OV101; Primary endpoint of change in overall CGI-I score. CGI-I will be used as a single primary endpoint, mainly due to the rare nature of Angelman syndrome, the lack of treatment options, the nonexistence of assessment instruments specific to Angelman syndrome, the heterogeneity of the disorder, and the lack of sensitivity or appropriateness of other validated measures. Based on feedback from the FDA, Ovid will develop a framework for study investigators to ensure uniform use of the validated CGI-I scale by focusing on specific symptoms that are relevant and important to patients with Angelman syndrome and their caregivers. Ovid expects to begin enrollment of the NEPTUNE trial in the second half of 2019, pending FDA concurrence on the study protocol and supporting framework and materials. Updates and further details of this trial, including secondary endpoints, will be provided upon trial initiation. In addition to the planned Phase 3 NEPTUNE trial, Ovid is initiating the ELARA clinical trial, an open-label extension study for individuals with Angelman syndrome who have completed any prior OV101 study. ELARA will use once-daily dosing and will assess long term safety and tolerability in addition to efficacy measures. Trial initiation activities are underway. The company is also exploring options for patients under four years of age.
https://thefly.com/landingPageNews.php?id=2832879
Tilray, University of Sydney partner to examine effects of cannabis on driving
Tilray announced that it partnered with researchers at the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney to complete a study examining the effects of cannabis on driving and cognitive function. “The Effects of Medicinal Cannabinoids on Driving” study was a double blind, placebo-controlled study that compared the effects of two varieties of cannabis – a variety containing high levels of THC and a variety containing a 1:1 balanced ratio of THC:CBD – to a placebo, which contained neither THC nor CBD. Tilray supplied the cannabis varieties for the study from its Good Manufacturing Practices certified facility in Nanaimo, British Columbia. The trial phase of this study was completed in 2018 and the published results are expected in 2019.
Natera’s Signatera assay shows treatment reponse prediction capacity
Natera presented data from two studies this week at the 2018 San Antonio Breast Cancer Symposium, demonstrating the ability of its Signatera research-use-only circulating tumor DNA assay to detect molecular residual disease up to two years prior to clinical relapse and to predict treatment response in breast cancer. In a cohort of 82 high-risk early-stage breast cancer patients receiving neoadjuvant therapy, the change of measurable ctDNA from positive to negative during neoadjuvant treatment predicted therapeutic response, while failure to clear ctDNA after neoadjuvant treatment correlated with poor clinical outcomes. ctDNA levels were also associated with tumor burden as determined by imaging. Personalized serial circulating tumor DNA analysis in high-risk early stage breast cancer patients to monitor and predict response to neoadjuvant therapy and outcome in the I-SPY 2 TRIAL. In a cohort of 49 breast cancer patients who received adjuvant therapy, Signatera detected molecular residual disease with a lead time of up to two years prior to clinical or radiological detection. Overall, Signatera detected clinical relapse with a sensitivity of 89 percent and specificity of 100 percent.
https://thefly.com/landingPageNews.php?id=2832901
Edwards Lifesciences sees FY19 revenue growth of 11%-15%
Outlook coming from the company’s Analyst Day presentation slides yesterday. The company also forecast global TAVR, or Transcatheter aortic valve replacement, opportunity beyond 2024 reaching $7B from $3.5B in 2018.
https://thefly.com/landingPageNews.php?id=2832915
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