WINNIPEG, Manitoba, July 2, 2015 (GLOBE NEWSWIRE) -- Viventia Bio Inc., a late clinical-stage company advancing a broad pipeline of novel anti-cancer agents, today announced that they have begun approving clinical trial centers for participation in its pivotal Phase 3 human clinical trial for Vicinium™. A recombinant fusion protein, Vicinium (also referred to as VB4-845) is being developed for treatment of high grade non-muscle invasive bladder cancer (NMIBC). Based on discussions with the U.S. Food and Drug Administration, Viventia has finalized its clinical protocol and plans to start enrolling patients within the next month at multiple sites in the US and Canada. Preliminary efficacy data from the trial are expected in the third quarter of 2016.
"We are excited to launch patient enrollment imminently for Vicinium, a highly differentiated, wholly biologic Targeted Protein Therapeutic designed to overcome the challenges and deficiencies of earlier-generation antibody drug conjugates," commented Stephen Hurly, Viventia's Chief Executive Officer. "Vicinium has been administered to more than 100 patients in Phase 1 and 2 clinical trials. Clinical results to date have demonstrated complete response rates of greater than 40% at 3 months with no drug-related serious adverse events." The findings were published in the Journal of Urology (www.jurology.com/article/S0022-5347%2812%2904199-7/pdf).
Glen MacDonald, Viventia's Chief Science Officer added, "No effective new drugs for high grade NMIBC have been approved in the past 25 years, and failure rates are high for current treatment of these patients. We are encouraged that our clinical trial data for Vicinium holds great promise for patients who have failed the standard treatment, BCG. As a targeted therapy, Vicinium is able to target the cancer cells directly and has to date avoided systemic toxicity. With a strong combination of efficacy and safety we look forward to driving the product development forward."
Viventia's open-label, multi-center Phase 3 clinical trial will assess efficacy and tolerability of intravesical administration of Vicinium in patients with high grade NMIBC (carcinoma in situ and/or papillary disease) refractory to treatment with bacillus Calmette–Guérin (BCG). The trial will be conducted at approximately 55 leading medical centers in the United States and Canada.
NMIBC is the second most common malignancy of the genitourinary system in the US, accounting for 70-80% of all bladder cancers, and the sixth most common cancer diagnosed. It is estimated that there will be 74,000 new cases of bladder cancer in the US and 16,000 deaths in the US in 2015, according to the Surveillance, Epidemiology and End Results Program (SEER) of the National Cancer Institute (see reference linked here). BCG was approved to treat NMIBC carcinoma in situ in 1990. As a front-line therapy, BCG, with or without transurethral resection of the bladder tumor (TURBT), is associated with high failure rates: 50 percent within one year and 90 percent within five years.
A recombinant fusion protein, Vicinium consists of a single chain EpCAM-targeting antibody fragment genetically fused to truncated Pseudomonas exotoxin, or exotoxin A (ETA). Vicinium targets and binds to cancer cells expressing EpCAM, a protein exclusively associated with epithelium and overexpressed on many epithelial cancers. Once bound, Vicinium is internalized and migrates within the cancer cell, where its toxin payload dissociates from the single chain antibody fragment and is then able to exert its cancer cell-killing activity. Vicinium is administered by direct instillation into the urinary bladder (intravesical delivery), consistent with current treatment paradigm for BCG. In addition, Vicinium's mechanism of action is complementary to use with chemotherapeutics or immune modulators.
About Viventia Bio
Viventia Bio is a late clinical-stage company advancing a broad pipeline of novel anti-cancer agents based on the Company's Targeted Protein Therapeutics (TPTs) platform. TPTs are fully biologic fusion constructs containing antibody fragments, a proprietary linker, and protein toxin payloads. The Company believes its platform offers significant advantages in treating cancer versus earlier technologies, including superior tumor targeting and better cancer cell-killing properties thru the utilization of protein payloads versus small molecules, as well as enhanced linker stability and more efficient manufacturing.
Viventia's lead clinical candidates, Vicinium™ and Proxinium™, are anticipated to progress in Phase 3 testing in 2015 for locoregional treatment of patients with non-muscle invasive bladder cancer (NMIBC) and squamous cell carcinoma of the head & neck (SCCHN), respectively. Earlier-stage programs are focused on de-immunized, systemic candidates, including VB6-845d, indicated for solid tumors and expected to enter Phase 1 testing in the first quarter of next year, as well as additional preclinical candidates targeting solid tumors. Viventia was founded by life sciences entrepreneur and philanthropist Leslie L. Dan.
Justin Jackson, Burns McClellan, on behalf of Viventia Bio 212-213-0006, ext.327