Blog Tag: Clinical Trials
Akili Interactive recently announced results of a trial on the company’s digital medicine product, AKL-T01. According to FierceBiotech, Akili plans to file AKL-T01 with the U.S. Food and Drug Administration (FDA) for clearance under the 510(k) medical device pathway as a novel treatment for children and adolescents with attention deficit/hyperactivity disorder (ADHD).
According to the article, unlike traditional drug treatments for ADHD, AKL-T01, also known as Project: EVO, is a video game patients play on a tablet device. AKL-T01 uses storytelling and reward
mechanisms, like those found in standard video games, and further uses adaptive algorithms to automatically adjust the level of stimulus up or down to target deficient cognitive neural systems in the brain and meet the specific needs of the patient.
The article further notes that in the randomized, controlled trial, 348 children and adolescents diagnosed with ADHD were evaluated before and after four weeks of at-home treatment with either AKL-T01 or an active control. According to Akili’s press release, children and adolescents who used AKL-T01 showed a statistically significant improvement in attentional functional compared to the children in the active control group. According to Akili, a full analysis of the results is underway and will be presented in upcoming peer-reviewed publications, scientific conferences, and medical meetings.
The use of interactive software as digital treatment is a relatively new trend. The FDA recently approved what it characterized as its first-ever mobile medical application, an application developed by Pear Therapeutics to treat substance use disorders. As reported by Reuters, Akili’s plan to file for FDA approval may pave the way for what would be the first such digital prescription product to tackle ADHD. Considering that Pear Therapeutics was recently selected to participate in the FDA’s digital health software precertification pilot program, the FDA has provided an indication that the agency may be interested in the type of digital therapy treatment Akili claims to offer.
Positive Clinical Results for Using Myriad’s BRACAnalysis CDx® for Identifying Breast Cancer Patients for Treatment with Lynaparza
Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib), AstraZeneca’s PARP inhibitor. The results are based on a collaborative effort between Myriad Genetics and AstraZeneca for identification and treatment of patients with metastatic breast cancer and underlying BRCA 1/2 mutations.
In 2014, the FDA approved the use of BRACAnalysis CDx to identify patient with advanced ovarian cancer that would benefit from treatment with olaparib. Jonathan Lancaster, the chief medical officer of Myriad Genetics stated that, “we believe the results of the OlympiAD trial support use of BRACAnalysis CDx test to help inform treatment decisions in the metastatic breast cancer setting and will expand the patient population who can benefit from BRCA testing.”
The recent announcement is the first report of data from a Phase 3 Clinical Trial (the OlympiAD trial) that compares treatment options in Metastatic Breast Cancer Patients with Germline BRCA1/2 Mutations. The treatments compared the responses to Lynparza and so-called physician’s choice chemotherapy, where the investigators will choose Capecitabine, Vinorelbine, or Eribulin. Mydriad’s BRACAnalysis CDx test was used to identify patients with germline BRCA 1/2 mutations and these patients showed a statistically-significant improvement of progression-free survival when treated with olaparib compared to treatment with a chemotherapy of the physician’s choice. Information about the clinical trial can be obtained here: https://clinicaltrials.gov/ct2/show/NCT02000622.
According to Myriad, BRACAnalysis CDx is an in vitro diagnostic device that detects and classifies variations of BRCA1 and BRCA2 in both protein coding and intron/exon junctions regions of the genes. The device analyzes genomic DNA obtained from whole blood. Small genetic variations including single nucleotide polymorphisms (SNPs) are identified using PCR with Sanger sequencing. Larger genetic variations, including large deletions and duplications, are detected using multiplex PCR.
According to MedicalXpress, expansive data from a company’s medical device clinical trials will soon be made broadly available to medical device researchers for the first time. The Yale University Open Data Access (“YODA”) Project will make data from certain Johnson & Johnson (“J&J”) businesses available to outside researchers. YODA will act as an independent gatekeeper to access the data.
Previously, only pharmaceutical data from J&J was available through the YODA program. Under the extended program that now includes data related to medical devices and diagnostics, clinical trial results from the Medical Devices and Diagnostics divisions of J&J will be made available. As with the J&J pharmaceutical data requests, YODA will review the requests for device/diagnostic patient data, which has been sanitized of patient identifying information. However, the agreement only covers products approved since early 2014 and thus excludes many products currently on the market. One device for which data will be available is J&J’s Thermocool Smarttouch catheter, a device used to treat atrial fibrillation that received approval in 2014 .
“advocates for the responsible sharing of clinical research data” and “is committed to open science and data transparency, and supports research attempting to produce concrete benefits to patients, the medical community, and society as a whole.”
Medical device giant Medtronic, Inc. has also partnered with YODA, albeit currently only with regard to Medtronic’s recombinant human bone morphogenetic protein-2 (rhBMP-2) data. Medtronic has previously shared medical device clinical trial data with the YODA Project for a single product, a bone formation product called “Infuse.” Given J&J’s expansion of its available data, other industry leaders, such as Medtronic, may well follow suit and make available additional data.
St. Jude Medical, Inc. issued a press release today announcing the first patient implant in a clinical trial of the company’s AMPLATZER™ Cardiac Plug (ACP), a device designed to prevent stroke in patients with non-valvular atrial fibrillation. According to the press release, the ACP is
[a] self-expanding occlusion device constructed from nitinol mesh, and delivered via catheter [and] is designed to completely seal the [left atrial appendage (LAA)] (a tubular-shaped, muscular appendage connected to the left atrium of the heart) at its opening, and minimize blood clots from forming in the LAA and migrating into the bloodstream.
The press release states that the trial will compare the safety and efficacy of the device to the traditional treatment option of using long-term, blood-thinning medication.