Uro Pipeline: IDE approval granted for implantable neurostimulator

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A prostate cancer vaccine and an infertility diagnostic tool are among the other pipeline products discussed in this round-up.

IDE approval granted for implantable neurostimulator

StimGuard recently announced that it has received FDA Investigational Device Exemption approval to launch a clinical trial of its percutaneously implantable device for the treatment of urgency urinary incontinence resulting from refractory overactive bladder (OAB) syndrome. The clinical trial will focus on implanting a small neurostimulator at the tibial nerve under ultrasound and utilizing a discreetly worn external transmitter to provide energy and therapy to the implanted device, according to StimGuard. The trial will assess the effectiveness of delivering pulsed electrical energy to surrounding tibial nerves that travel to the sacral nerves to regulate bladder function.

Lancet data: Thyroid Ca Tx may have benefit in metastatic RCC

Results from an investigational phase II clinical trial evaluating lenvatinib in combination with everolimus (Afinitor) and lenvatinib and everolimus alone for the treatment of metastatic renal cell carcinoma (mRCC) were recently published online ahead of print in The Lancet Oncology (Oct. 15, 2015). The randomized, open-label, multicenter trial evaluated progression-free survival in patients treated with the combination (n=51), patients who received everolimus alone (n=50), and patients treated with lenvatinib monotherapy (n=52). Based on the results of the study, the FDA granted lenvatinib breakthrough therapy designation for patients with advanced or metastatic RCC who were previously treated with a vascular endothelial growth factor-targeted therapy. Lenvatinib is currently available as LENVIMA for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

Next: Companies enter agreement for phase II trial of prostate Ca vaccine

Companies enter agreement for phase II trial of prostate Ca vaccine

Generex Biotechnology Corporation’s immunotherapeutics subsidiary, Antigen Express, Inc. has entered into a memorandum of understanding with CompanDX Ltd. to conduct a phase II clinical trial of the Antigen Express proprietary prostate cancer vaccine AE37. Under the terms of the agreement, milestone payments and royalties will be paid to Antigen Express in exchange for the rights to AE37 for the treatment of prostate cancer.

Studies demonstrate infertility diagnostic tool’s clinical utility

Aytu BioScience, Inc. recently presented clinical data from two prospective clinical studies of its MiOXSYS System that demonstrated its clinical utility as a tool for measuring oxidation-reduction potential to assess the degree of oxidative stress levels in human semen, which is broadly implicated as a major cause of male infertility. The results were presented at the American Society for Reproductive Medicine annual meeting in Baltimore.

Next: Phase II trial of bladder Ca agent reaches target patient enrollment

Phase II trial of bladder Ca agent reaches target patient enrollment

Borealis-2, an investigator-sponsored, randomized phase II bladder cancer trial, has met its target enrollment of 200 patients, reported OncoGenex Pharmaceuticals, Inc. Designed to evaluate apatorsen in combination with docetaxel (Taxotere) in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy, Borealis-2 is sponsored by Hoosier Oncology Group and is being conducted at 27 sites across the United States. Apatorsen (OGX-427) is designed to inhibit production of heat shock protein 27, disable cancer cells’ defenses, and overcome treatment resistance.