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Clinical and Regulatory Plans for Two Lead Products Announced
Novel Cancer Treatment Paradigm Reported
SAN DIEGO, Feb. 14, 2014 /PRNewswire/ -- MultiVir, a leader in gene therapies for cancer treatment, presented to the investment community at the Leerink Global Healthcare Conference.
Highlights of the presentation included an overview of the development plans for the company's two lead products which are supported by strong pre-clinical and clinical data. MultiVir's adenoviral p53 (Ad-p53) and adenoviral interleukin 24 (Ad-IL 24) are advancing towards large randomized, controlled Phase II adaptive trials designed to support registration.
The Ad-p53 product, being developed for the treatment of colorectal cancer liver metastases, targets the most common molecular defect in all cancers, the abnormal p53 tumor suppressor gene. Ad-IL 24 under development for recurrent head and neck cancer, has equally powerful tumor suppressor activity and also induces potent anti-tumor immune responses.
MultiVir's lead products have unique therapeutic activities with multiple mechanisms of action. MultiVir's tumor suppressor gene therapies inhibit tumor growth, kill cancerous cells, enhance anti-tumor immunity, decrease tumor blood supply and sensitize tumors to conventional chemotherapy and radiation treatments. The products are well-tolerated and provide synergistic interactions with chemotherapy, radiation and targeted treatments.
In three previous clinical studies involving over 100 patients, a biomarker predictive of Ad-p53 efficacy was identified. Ad-p53 treatment in patients with favorable p53 biomarker profiles resulted in statistically significant increased tumor responses, time to progression and survival compared to patients with unfavorable profiles. Approximately 75% of cancer patients have tumors with p53 biomarkers favorable for Ad-p53 therapy. In previous pre-clinical and clinical studies, Ad-p53 demonstrated synergistic efficacy in combination treatments with FOLFIRI chemotherapy and with the monoclonal antibody cetuximab that are routinely employed in the therapy of colorectal cancer. Ad-p53 will be combined with these standard treatments as the initial indication for MultiVir's Ad-p53 clinical development program for colorectal cancer.
MultiVir Ad-IL 24
A total of 35 patients with advanced solid tumors were treated with Ad-IL 24 either alone or in combination with radiation. Ad-IL 24 induced programmed cell death (apoptosis) detected by TUNEL assay in 100% of the 22 tumors evaluated, even in patients who had failed prior therapies. Tumor growth control (stable disease or reduced tumor size) was observed in 44% of the treated lesions. Patients treated with Ad-IL 24 had an increased number of CD8+ immune killer T cells consistent with the role of IL 24 as an anti-tumor immunity stimulating cytokine.
Ad-IL 24 was combined with radiation in patients with locally advanced, unresectable head and neck cancer. The tumor response rate was 70% (7 of 10 patients with 4 having complete responses and 3 partial responses by RECIST criteria). Remarkably, none of the patients in the study had disease progression during the trial's response evaluation period.
In pre-clinical studies, Ad-IL 24 demonstrated enhanced efficacy in combination with either cisplatin chemotherapy or radiation, which are standard treatments for head and neck cancer. Ad-IL 24 will be combined with cisplatin based chemotherapy as the initial indication for MultiVir's Ad-IL 24 clinical development program for squamous cell carcinoma of the head and neck.
Robert E. Sobol, MD, MultiVir's President and CEO stated: "Our two lead products have shown very promising results in previous pre-clinical and clinical studies which support our regulatory plans for Ad-p53 in colorectal cancer and Ad-IL 24 in head and neck cancer to improve outcomes when combined with conventional treatments."
MultiVir's Novel Cancer Treatment Paradigm
Conventional cancer therapies typically demonstrate decreased efficacy with each subsequent line of treatment. In contrast to standard therapies, MultiVir's multiple viral platforms demonstrated statistically significant increased efficacy when administered sequentially in pre-clinical studies. Similarly, MultiVir viruses engineered to deliver multiple therapeutic genes had statistically significant increased efficacy compared to gene therapies that delivered a single therapeutic gene. "These multi-viral, multi-gene therapy results suggest a new paradigm for cancer therapeutics where subsequent treatments may have increased rather than decreased efficacy" stated Dr. Sobol.
About MultiVir, Inc.
MultiVir is a clinical stage gene therapy company developing oncology products that employ multiple genetically engineered viruses to deliver tumor suppressor and immunotherapeutic genes. The company's broad technology platforms target cancers' most fundamental and common molecular defects (p53 and retinoblastoma tumor suppressors). MultiVir was founded by IDEC co-founder Robert E. Sobol, MD.
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements made herein are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict. The actual results may differ materially from those contained in our projections or forward-looking statements.
Robert E. Sobol, MD
Nicholas Puro, JD
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