Products in the pipeline for prostate cancer, bladder cancer, and much more.
Agent reduces urinary oxalate excretion in stone patients
Findings from a phase IIa multicenter, open-label study demonstrated a statistically significant reduction of urinary oxalate excretion in recurrent calcium oxalate kidney stone patients with hyperoxaluria relative to baseline who were treated with ALLN-177 (p=.0084). ALLN-177 is an orally administered recombinant oxalate degrading enzyme being developed for the chronic management of hyperoxaluria and kidney stones. The agent was well tolerated and no serious adverse events were reported, according to developer Allena Pharmaceuticals, Inc.
AACR data: Bladder cancer test demonstrates sensitivity, specificity
The diagnostic test PanC-Dx showed a high level of sensitivity and specificity in non-invasive detection of urothelial carcinoma, according to research presented at the American Association for Cancer Research annual meeting in Philadelphia. Another clinical trial of the test is currently enrolling patients, developer OncoCyte reported in a press release.
Collaboration to develop prostate cancer tests announced
CytoTest Inc., the Uniformed Services University of the Health Sciences, and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. have signed a Cooperative Research and Development Agreement (CRADA). Under the agreement, CytoTest will collaborate with the Center for Prostate Disease Research (CPDR) on the development of next-generation approaches to prostate cancer diagnosis and prognosis. As part of the initial CRADA efforts with CPDR, CytoTest will provide reagents, instrumentation, manufacturing, scale-up, biomarker screening services, and assay construction capabilities to advance the development of these markers for use in clinical diagnostic testing. The collaboration combines CPDR’s discovery and translational research abilities and unique clinical resources with CytoTest’s genomic medicine expertise and diagnostic assay development infrastructure, CytoTest said in a press release.
Patient enrollment complete for clinical utility study of PCa test
MDxHealth SA has completed patient enrollment into its prospective, randomized PASCUAL clinical utility study with ConfirmMDx for Prostate Cancer. The study, which will evaluate the impact of the ConfirmMDx test results on physician decisions for repeat biopsy, enrolled 600 patients from 17 leading urology practices across the United States, MDxHealth said.
Settlement allows for launch of generic sildenafil in 2017
Mylan Inc. and Mylan Pharmaceuticals Inc. have entered into a settlement and license agreement with Pfizer Inc., Pfizer Limited, and Pfizer Ireland Pharmaceuticals to settle patent litigation relating to Mylan’s abbreviated new drug application (ANDA) filed with the FDA for sildenafil citrate tablets in 25, 50, and 100 mg. This product is the generic version of Viagra. Under the terms of the agreement, Mylan says it will be able to launch its ANDA products pursuant to a royalty-bearing license as early as Dec. 11, 2017, or sooner under certain conditions, subject to FDA approval.
Investigational prostate Ca test bests PSA in specificity
In a 300-patient U.S. pilot study, the investigational blood test MiCheck demonstrated 85% specificity and 60% sensitivity compared with 40% specificity for existing PSA screening technology. Developer Minomic International Ltd. reported that a final trial of MiCheck will be launched in the U.S. later this year, with scientists screening 1,200 patient samples to provide final stage validation. These results, combined with results from the 300-patient study, will be included in a comprehensive package submitted to the FDA for regulatory approvals, the company said.
Technology demonstrates single-cell analysis for circulating tumor cells
Epic Sciences said its no cell left behind technology has successfully integrated single-cell isolation and downstream genetic analysis of circulating tumor cells to the platform’s capabilities. Data describing next-generation sequencing and copy number variation analyses of single prostate cancer cells in a blood sample were presented at the American Association for Cancer Research annual meeting in Philadelphia. In the study, independent isolates of human blood cells spiked with prostate cancer cell lines were processed on the Epic platform and genetic material from individual cells was subsequently sequenced. Profiles for copy number variation, a common category of genetic aberration, demonstrated a high level of correlation among replicate samples, demonstrating the reproducibility of the no cell left behind platform, according to Epic Sciences.
Pilot study initiated to assess feasilibity of assays to detect PCa
VolitionRx Limited has initiated a pilot study to assess the feasibility of the company’s proprietary NuQ assays in detecting prostate cancer. The study is in collaboration with ImmuneHealth, a global biomarker contract research organization, and is taking place in Belgium. In the prospective study, 120 blood samples will be collected from patients across four Belgian hospitals and analyzed by ImmuneHealth using VolitionRx’s NuQ assays, which are based on the company’s proprietary Nucleosomics technology. In addition to determining the test’s ability to accurately detect prostate cancer, VolitionRx said the study will also assess the tests’ ability to distinguish among the different prostate conditions and healthy samples. If the test demonstrates significant accuracy, it could have the potential to become an early-stage screening tool.
Proof of concept reported for oncology drug candidate
Novogen recently reported that one of its oncology pipeline drug candidates, Anisina (ATM-3507), has achieved a major milestone in its development, confirming the concept that comprehensive destruction of a cancer cell’s cytoskeleton can deliver a powerful anti-cancer effect. The agent targets the protein tropomyosin Tpm3.1. It has been announced previously that anti-tropomyosin drugs, in combination with anti-mitotic drugs, boost the cancer-killing ability of a drug such as vincristine 20-fold in vitro against neuroblastoma cancer cells. The next step was to confirm that this anti-cancer effect was transferable to animals, which Novogen says its research has done. Novogen says it is looking to use Anisina to potentiate the anti-cancer effect of anti-mitotics in prostate and several other cancers.
Prostate cancer test has potential stratify risk of tumor advancement
The first clinical data were presented on a novel live tumor cell phenotypic diagnostic test for prostate cancer at the Genitourinary Cancers Symposium in Orlando, FL. Developer Cellanyx Diagnostics says the data demonstrate the test’s potential to stratify the risk of tumor advancement and metastasis in patients diagnosed with low and intermediate Gleason scores in prostate cancer. The results also demonstrated the test’s potential to distinguish between normal and tumor cells and specifically among Gleason grade 6 versus 7 and Gleason 7 (4+3) versus Gleason 7 (3+4).
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