Other pipeline products discussed in this article include agents for urinary catheter blockage, prostate cancer, bladder cancer, and overactive bladder.
Phase III data show drug’s benefit in castrate-resistant prostate Ca
Phase III data on the investigational prostate cancer agent custirsen were presented at the European Cancer Congress in Vienna, Austria, OncoGenex Pharmaceuticals, Inc. announced. Results from exploratory analyses of the phase III SYNERGY trial demonstrated that custirsen treatment significantly lowered serum clusterin levels from baseline in men with metastatic castrate-resistant prostate cancer. Among patients with lower serum clusterin levels, the data also showed a correlation to an overall survival benefit for custirsen-treated patients who were at increased risk for poor outcomes. Separately, phase II results on the bladder cancer agent apatorsen confirmed that patients with advanced bladder cancer at increased risk for poor outcomes had increased baseline levels of circulating tumor cells (CTCs) and of serum heat shock protein 27 (Hsp27). Baseline Hsp27 and CTC levels were independent risk factors for survival outcomes, OncoGenex said.
Company to present phase IIb results on catheter blockage agent
NovaBay Pharmaceuticals, Inc. said it will soon report results of a clinical study with its proprietary anti-microbial compound auriclosene (NVC-422, or AIS) to reduce urinary catheter blockage and encrustation in patients with long-term indwelling urinary catheters. The phase IIb study results will include data from 34 evaluable subjects with indwelling urinary catheters randomized into two equal arms. Subjects received irrigations of AIS or its vehicle administered two times per week for 4 weeks. The study’s objectives are to evaluate catheter flow rate reduction, early removal of catheters due to clinical blockage, and safety and tolerability of AIS.
FDA advisory committee votes on safety, efficacy of bladder Ca Tx
The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee met Nov. 18, 2015 to discuss the safety and efficacy of Telesta Therapeutics Inc.’s Biologics License Application for Mycobacterium phlei cell wall-nucleic acid complex (MCNA). The joint committee voted 18 no to 6 yes, with no abstentions, on the following question: “Does MCNA have an overall favorable benefit-risk profile for the treatment of non-muscle invasive bladder cancer [NMIBC] at high risk of recurrence or progression in adult patients who failed prior BCG immunotherapy, e.g., in patients who are BCG-refractory or BCG-relapsing?” The FDA is not bound by the joint committee’s recommendation but does takes its advice into consideration when considering the approval of a new therapeutic. The FDA’s Prescription Drug User Fee Act review goal date for MCNA is Feb. 27, 2016. MCNA is a biologic therapy developed to provide high-risk NMIBC patients who are refractory to or relapsing from first line therapy with BCG with a therapeutic alternative to surgery.
Castration-resistant PCa Tx meets primary endpoint in phase II trial
The investigational agent zoptarelin doxorubicin (formerly AEZS 108) met the primary endpoint of a phase II clinical trial in castration- and taxane-resistant prostate cancer and demonstrated good tolerability, Aeterna Zentaris reported. The primary endpoint was clinical benefit defined as remaining progression free by RECIST and PSA after treatment for 12+ weeks.
Company announces development of intra-vaginal OAB agent
Juniper Pharmaceuticals has added three new products to its proprietary pipeline, each of which utilize the company’s proprietary multi-segment intra-vaginal ring (IVR). One of the products, JNP-0101, is an oxybutynin IVR for the treatment of overactive bladder. Juniper said it plans to submit an investigational new drug application to the FDA and initiate clinical studies with JNP-0101 in the second half of 2016.
Liquid Bx predicts objective clinical features present in RP specimens
Exosome Diagnostics, Inc. presented new positive data from a clinical study for the company’s novel, urine-based prostate cancer liquid biopsy, ExoIntelliScore Prostate (formally referred to as Exo106). The data, presented at the European Cancer Congress in Vienna, Austria, demonstrated that ExoIntelliScore Prostate accurately predicted, in pre-radical prostatectomy (RP) urine samples of patients with prostate cancer, objective clinical features present in RP specimens, and also provided initial improved discrimination of RP Gleason score 4+3 disease.
Phase II data: Urothelial Ca agent increases progression-free survival
A phase II study of Eli Lilly and Co.’s ramucirumab (CYRAMZA) in combination with docetaxel (Taxotere) met its primary endpoint, demonstrating a statistically significant increase in progression-free survival for patients with locally advanced or metastatic urothelial carcinoma who failed prior platinum-based therapy. The results were presented at the European Cancer Congress in Vienna, Austria. Based on these findings, Lilly recently initiated a phase III trial called RANGE, which has begun to enroll patients.
Study to evaluate androgen receptor modulator in post-RP men
Transition Therapeutics Ireland Limited (TTIL) has entered into an agreement for an investigator-led clinical study of drug candidate TT701 with Brigham and Women’s Hospital, Boston. TTIL will support a phase II study to evaluate TT701, a selective androgen receptor modulator, as a therapy to improve the symptoms of androgen deficiency in men with prostate cancer who have undergone radical prostatectomy. The study is expected to enroll up to 125 subjects and will be performed at selected specialized clinical sites, including Brigham and Women’s Hospital.
Hyperoxaluria agent reduces urinary oxalate excretion in stone patients
Treatment with ALLN-177 resulted in a statistically significant reduction of urinary oxalate excretion in patients with secondary hyperoxaluria (p=.0084), according to phase II data presented at the American Society of Nephrology Kidney Week in San Diego. ALLN-177 is currently being developed for the treatment of secondary hyperoxaluria in patients with a history of calcium oxalate kidney stones. The study also showed that ALLN-177 was well tolerated in the target patient population. Based on these data, Allena Pharmaceuticals has initiated two additional phase II clinical trials of ALLN-177 in patients with secondary hyperoxaluria.
Nonmuscle-invasive bladder Ca drug moves into phase III trial
Spectrum Pharmaceuticals has initiated a phase III clinical study for apaziquone, its novel, potent pro-drug. Apaziquone is an alkylating agent being investigated as intravesical treatment for patients with nonmuscle-invasive bladder cancer (NMIBC), administered as one or two instillations immediately following transurethral resection of bladder tumors. The randomized, double-blind, placebo-controlled, multicenter trial will enroll patients with Ta, G1-G2 NMIBC. Patients will be randomized to receive either one instillation of apaziquone, two instillations of apaziquone, or placebo, with a primary endpoint of time to recurrence, Spectrum Pharmaceuticals said.
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