December 18, 2017
Novocure Receives IDE Approval for PANOVA 3 Pivotal Trial
Novocure announced that it has received a U.S. Food and Drug Administration Investigational Device Exemption (IDE) approval to initiate its PANOVA 3 clinical trial. The randomized Phase III pivotal trial is designed to determine the efficacy and safety of Tumor Treating Fields (TTFields) with nab-paclitaxel and gemcitabine as a front-line treatment for unresectable locally advanced pancreatic cancer. PANOVA 3 is Novocure’s third Phase III pivotal trial initiated to study solid tumors beyond glioblastoma.
PANOVA 3 is a randomized, open-label trial that will include 556 patients with unresectable locally advanced pancreatic cancer. Patients should have an Eastern Cooperative Oncology Group (ECOG) score of 0-2 and no prior progression or treatment. Experimental-arm patients will use a TTFields delivery system tuned to 150 kHZ for at least 18 hours a day until the disease progresses. The primary endpoint is overall survival. The secondary endpoints include progression free survival, local progression free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, resectability rate and toxicity.
Novocure accelerated the trial design of PANOVA 3 after learning the results of its Phase II pilot trial of TTFields plus nab-paclitaxel and gemcitabine in patients with advanced pancreatic cancer. TTFields in combination with nab-paclitaxel and gemcitabine more than doubled progression free survival and the one-year survival rate compared to nab-paclitaxel and gemcitabine-treated historical controls.
NovoCure announced that with the FDA IDE approval, the company is now working closely with trial sites and institutional review boards to open sites and enroll patients as quickly as possible.
See more about Optune on Meddevicetracker.
DarioHealth Receives Regulatory Approval in Australia
DarioHealth announced it received the Therapeutic Goods Administration (TGA) Mark for its Lightning-enabled version of the Dario Blood Glucose Monitoring System in Australia. The regulatory approval ensures that consumers in the Australian market will be able to receive the same quality user experience with DarioHealth on the latest Apple devices, including the brand-new iPhone 8 and iPhone X.
DarioHealth can now successfully offer its proprietary glucose meter with either a 3.5mm headphone jack or Lightning connector to users in Australia.
In addition to the TGA approval, users in the U.K. will be able to purchase the Lightning-enabled Dario device at the end of 2017, while sales of the device will begin in Australia by January 2018. DarioHealth is still waiting on approval from regulatory agencies in the U.S. and Canada, which is expected in the coming months.
See more about the Dario Smart Meter on Meddevicetracker.
December 19, 2017
Cancer Genetics Receives New York State Approval
Cancer Genetics announced it has received approval for Thermo Fisher Scientific’s Oncomine Dx Target Test from the New York State Department of Health.
The Oncomine Dx Target Test is a next-generation sequencing (NGS)-based companion diagnostic (CDx) that simultaneously screens tumor samples for multiple biomarkers associated with three FDA-approved therapies for non-small cell lung cancer (NSCLC), including the combined therapy of dabrafenib and trametinib, crizotinib, or gefitinib.
See more about the Oncomine Dx Target Test on Meddevicetracker. As this product is a companion diagnostic, the full development history of the associated drugs can be seen on Biomedtracker.
EF-14 Phase III Trial Data of Optune Published in JAMA
NovoCure announced that the final analysis of its Phase III pivotal trial of Optune in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) has been published in the Journal of the American Medical Association (JAMA), titled "Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma." The final analysis proved that overall survival and progression free survival were each significantly extended by 37 percent for patients who received Optune plus temozolomide compared to patients who received temozolomide alone.
In this randomized, open-label trial, 695 patients with glioblastoma whose tumor was resected or biopsied and had completed concomitant radiochemotherapy (median time from diagnosis to randomization, 3.8 months) were enrolled at 83 centers and followed up through December 2016. A preliminary report from this trial was published in 2015; this report describes the final analysis.
Patients were randomized 2:1 to tumor-treating fields (TTFields) plus maintenance temozolomide chemotherapy (n = 466) or temozolomide alone (n = 229). The TTFields, consisting of low-intensity, 200 kHz frequency, alternating electric fields, was delivered (≥ 18 hours/d) via 4 transducer arrays on the shaved scalp and connected to a portable device. Temozolomide was administered to both groups (150-200 mg/m2) for 5 days per 28-day cycle (6-12 cycles).
The primary endpoint was the progression-free survival (tested at α = .046). The secondary endpoint was the overall survival (tested hierarchically at α = .048).
Of the 695 randomized patients (median age, 56 years; IQR, 48-63; 473 men [68%]), 637 (92%) completed the trial. The five-year survival rate increased from five percent to 13 percent for patients treated with Optune together with temozolomide versus patients treated with temozolomide alone. Median progression-free survival from randomization was 6.7 months in the Optune-temozolomide group and 4.0 months in the temozolomide-alone group (HR, 0.63; 95% CI, 0.52-0.76; P < .001). Median overall survival was 20.9 months in the Optune-temozolomide group vs 16.0 months in the temozolomide-alone group (HR, 0.63; 95% CI, 0.53-0.76; P < .001). Systemic adverse event frequency was 48% in the Optune-temozolomide group and 44% in the temozolomide-alone group.
The overall survival benefit of Optune together with temozolomide compared to temozolomide alone was seen across all patient subgroups including subgroups with the worst prognosis who have benefitted less from previous therapies – patients 65 years of age or older and patients with unmethylated MGMT promoter.
There was no increase in systemic adverse events from Optune plus temozolomide versus temozolomide alone. The only common adverse reaction from Optune treatment was mild to moderate skin toxicity underneath the transducer arrays occurred in 52% of patients who received TTFields-temozolomide vs no patients who received temozolomide alone.
In the final analysis of this randomized clinical trial of patients with glioblastoma who had received standard radiochemotherapy, the addition of TTFields to maintenance temozolomide chemotherapy vs maintenance temozolomide alone, resulted in statistically significant improvement in progression-free survival and overall survival. These results are consistent with the previous interim analysis.
See more about Optune on Meddevicetracker.
December 20, 2017
Avinger Receives CE Mark Approval for Pantheris
Avinger announced Conformité Européenne (CE) Marking approval for its next generation Pantheris Lumivascular atherectomy system, one of the first image-guided atherectomy devices for the treatment of Peripheral Arterial Disease (PAD). The novel design features of the next generation of Pantheris include a simplified single balloon system for both apposition of the device and occlusion of blood flow, a stiffer shaft for increased pushability, a more robust nose cone with the option for more tissue storage capacity, and an enhanced cutter design.
Avinger expects to initiate the first clinical experiences with the new device in Europe in the near future.
See more about Pantheris on Meddevicetracker.
K2M Receives CE Mark Approval of the CAPRI Cervical 3D System
K2M Group Holdings announced that it received a CE Mark for its CAPRI Cervical 3D Expandable Corpectomy Cage System featuring Lamellar 3D Titanium Technology, and the successful completion of its first surgical case.
The CAPRI Cervical 3D Expandable Cage System stabilizes the cervical spine in cases of vertebral body resections resulting from trauma or tumor. Offered in various footprint options, its continuous in-situ adjustment capabilities allow surgeons to lock the cage with set screws at desired heights and lordotic angles within the expansion range of the implant. The system also allows for fixed endplate angulation of 0°, 5°, and 10° to accommodate surgeon preference and vertebral anatomy.
K2M's Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the CAPRI Cervical 3D Expandable Corpectomy Cages are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that pre-clinical data have associated with bone growth activity. Lamellar 3D Titanium Technology incorporates a porous structure along with rough surfaces to allow the potential for bony integration throughout the cage.
See moreabout the CAPRI Corpectomy Cage System on Meddevicetracker.
December 21, 2017
Avinger Files 510(k) Application for Next-Generation Pantheris
Avinger announced the Company submitted a new 510(k) application to the U.S. Food & Drug Administration (FDA) for its next generation Pantheris Lumivascular atherectomy system, an image-guided atherectomy device for the treatment of PAD. The novel design features covered in the filing include a simplified single balloon system for both apposition of the device and occlusion of blood flow, a stiffer shaft for increased pushability, a more robust nose cone with the option for more tissue storage capacity, and an enhanced cutter design. This next generation device is not available for commercial sale in the U.S. at this time.
The Company said this filing will lead to FDA clearance of the next generation device in the U.S. by early next year, which would allow the product to be commercially available by the end of the first quarter.
See more about Pantheris on Meddevicetracker.
CANbridge Life Science Submits IND in China
CANbridge announced that it has entered into a strategic partnership with Amoy Diagnostics (AmoyDx) to develop a CAN017 biomarker companion diagnostic. Preclinical data indicates that high Neuregulin 1 (NRG1) gene expression in ESCC tumors correlates to improved CAN017 response rates in animals, making it a possible biomarker for CAN017 in ESCC.
CAN017 is an ErbB3 (HER3) inhibitory antibody candidate. Preclinical work showed a potential to treat ESCC. CANbridge acquired the worldwide development rights (excluding North America) from US-based AVEO in 2016, after CAN017 (then called AV-203) had completed a US Food and Drug Administration-approved Phase I trial in solid tumors. CANbridge announced that it has submitted an Investigational New Drug (IND) application to the China Food and Drug Administration (CFDA) for a Phase Ib/III study of CAN017 in esophageal squamous cell cancer (ESCC).
CytoSorbents Receives IDE Approval for REFRESH-2 Trial
CytoSorbents announced that the U.S. Food and Drug Administration (FDA) has granted approval of its REFRESH II Investigational Device Exemption (IDE) application, with conditions. These conditions relate to requested clarifications and changes to the patient consent form and Instructions for Use document, which have now been modified. Based on FDA guidance, study initiation and patient enrollment can now begin at each clinical center with site institutional review board (IRB) approval and the revised documentation.
The REFRESH 2 trial is a randomized, controlled, multi-center, clinical trial designed to evaluate intraoperative CytoSorb use as a therapy to reduce AKI, as measured by Kidney Disease Improving Global Outcomes (KDIGO) criteria, following complex cardiac surgery. The trial will enroll up to 400 patients undergoing elective, non-emergent open heart surgery for either valve replacement, or aortic reconstruction with hypothermic cardiac arrest. Control patients will receive standard of care during surgery, while Treatment patients will receive standard of care with dual parallel CytoSorb cartridges in a heart-lung machine bypass circuit that are intended to reduce toxic inflammatory mediators and renal toxins such as plasma free hemoglobin and activated complement, during surgery. Other secondary and exploratory endpoints include time on mechanical ventilation, the use of vasopressors or other hemodynamic support, days in the intensive care unit, reduction in inflammatory mediators, and mortality at 30 days, for example.
See more about CytoSorb on Meddevicetracker.
December 22, 2017
Roche Announces Acquisition of Ignyta
Roche and Ignyta announced a definitive merger agreement for Roche to fully acquire Ignyta at a price of $27.00 per share in an all-cash transaction. This corresponds to a total transaction value of $1.7 billion on a fully diluted basis. This price represents a premium of 74% to Ignyta’s closing price on December 21, 2017 and a premium of 71% and 89% to Ignyta’s 30-day and 90-day volume weighted average share price on December 21, 2017, respectively. The merger agreement has been unanimously approved by the boards of Ignyta and Roche.
Under the terms of the merger agreement, Roche will promptly commence a tender offer, to acquire all outstanding shares of Ignyta common stock, and Ignyta will file a recommendation statement containing the unanimous recommendation of the Ignyta board that Ignyta’s shareholders tender their shares to Roche. Following completion of the tender offer, Roche will acquire all remaining shares at the same price of $27.00 per share through a second step merger. The closing of the transaction is expected to take place in the first half of 2018.