Urology Product Preview

FDA grants IDE approval to conduct clinical study of prostate Ca device
AngioDynamics recently announced that the FDA has granted investigational device exemption approval to conduct a clinical study of the NanoKnife System for the ablation of focal prostate cancer. The company said it is moving forward with institutional review board submissions and anticipates commencing patient enrollment in the company’s fiscal 2014 second quarter, which ends Nov. 30, 2013.
Separately, AngioDynamics has established a partnership with the Clinical Research Office of the Endourological Society and is pursuing a study to establish evidence for the NanoKnife System’s position within the treatment armamentarium for low-/intermediate-risk localized prostate cancer. The study will involve six European centers and 200 patients.

Antibiotic receives FDA ‘qualified’ status for complicated UTI
The FDA has designated the investigational antibiotic eravacycline as a Qualified Infectious Disease Product (QIDP). The QIDP designation, granted for complicated urinary tract infection and complicated intra-abdominal infection indications, will make eravacycline eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act, according to Tetraphase Pharmaceuticals, Inc., which is developing the agent. These incentives include priority review and eligibility for fast-track status. Eravacycline is being developed as a broad-spectrum intravenous and oral antibiotic for use as a first-line empiric monotherapy for the treatment of multidrug-resistant infections, including multi-drug resistant gram-negative infections.

Phase I study launched for advanced prostate Ca agent
Bellicum Pharmaceuticals has initiated treatment of the first patient in a study of BPX-201 dendritic cells in combination with activating agent AP1903. The phase I dose-escalation trial in patients with metastatic castrate-resistant prostate cancer was designed to evaluate the safety, tolerability, and clinical outcomes of BPX-201 and AP1903, which incorporate the company’s second-generation DeCIDe immunotherapy technology.

Promising animal study data on ED agent presented at AUA meeting
Researchers presenting data at the AUA annual meeting in San Diego said they have demonstrated the ability to deliver Melanotan-II (MT-II) peptides orally in animal trials. They also concluded that, “Melanotan-II (MT-II), a centrally acting synthetic melanocortin analog, may in the future provide oral as-needed therapy for men with erectile dysfunction.” The next steps include human trials to build on the already-proven subcutaneous delivery by performing additional studies using the novel oral MT-II formulation and proceeding with human dosing in a phase I/II program, according to Competitive Technologies, Inc., which is working with Xion Pharmaceuticals to develop the drug.

Successful IND filing made for molecule targeting prostate cancer
Jubilant Biosys Ltd. recently announced the FDA acceptance of the investigational new drug filing for a novel molecule targeting prostate cancer with Endo Pharmaceuticals. This molecule will now progress toward the next phase of development and is anticipated to go into clinical trials by late 2013, according to Jubilant Biosys.

Undergarment would replace leg straps from catheter bags
A Massachusetts-based inventor has developed an undergarment that replaces the leg straps from catheter bags. The Drainage Bag Partner can be fastened to boxer shorts or spandex underwear, and allows for a normal feel of using the bathroom, according to the inventor. The design was submitted to the Boston office of InventHelp and is currently available for licensing or sale to manufacturers or marketers.

Data presented for investigational IDO pathway inhibitor
Preclinical data for NLG919, a potent IDO (indoleamine-(2,3)-dioxygenase) pathway inhibitor, was recently presented at the American Association for Cancer Research annual meeting in Washington. These data demonstrate that NLG919 potently inhibits the IDO pathway in vitro and in cell-based assays, is orally bioavailable, and has a favorable pharmacologic and toxicity profile, according to NewLink Genetics Corp., which is developing the agent. NLG919 is the second pipeline candidate from NewLink’s IDO Pathway Inhibitor technology platform to be announced. This platform has also produced indoximod (NLG8189 or D1-MT), which is currently in phase II clinical trials for the treatment of prostate cancer and metastatic breast cancer. Furthermore, NLG919 and indoximod show synergistic T-cell activation and antitumor activity, NewLink Genetics said.

RNA/DNA ‘capture’ products may help predict prostate Bx outcome
Exosome Diagnostics and QIAGEN N.V. have entered into a partnership to develop and commercialize high-performance, co-branded kit products for the capture and processing of RNA and DNA from biofluid exosomes and other microvesicles. The partnership is designed to accelerate global availability of Exosome Diagnostics’ platform technology products, enabling researchers and drug developers to obtain repeated, real-time genetic “snapshots” of disease from patients’ blood, urine, or cerebrospinal fluid without the need for tissue biopsy, according to Exosome. The company recently presented data at the AUA annual meeting in San Diego demonstrating the performance of urine exosome technology in accurately predicting the outcome of a prostate biopsy.

Phase I data for advanced PCa agent shows anti-tumor activity
Final data for the phase I portion of the ongoing phase I/II trial of the investigational oncology compound zoptarelin doxorubicin (AEZS-108) demonstrated the compound’s promising anti-tumor activity in heavily pre-treated men with castration- and taxane-resistant prostate cancer, reported Aeterna Zentaris Inc., which is developing the compound. This was a dose-escalation phase I trial in men with castration- and taxane-resistant prostate cancer to confirm the dose established in a phase I trial in women with refractory endometrial and ovarian cancer. Patients received zoptarelin doxorubicin every 21 days until progression or unacceptable toxicity. The primary endpoint was safety. Data were presented at the American Society of Clinical Oncology annual meeting in Chicago.

Phase IIb clinical trial launched for advanced prostate Ca vaccine
CureVac GmbH has initiated a double-blind, randomized phase IIb clinical trial of its RNActive cancer vaccine, CV9104, for the treatment of patients with castration-resistant prostate cancer. The trial will enroll up to 200 patients in eight European countries to study CV9104 in chemotherapy-naïve patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. The study’s primary endpoint is overall survival. Eligible patients can enroll in the study through November 2013, according to the company.

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