SAN DIEGO, Feb. 01, 2018 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) and the Mycoses Study Group Education and Research Consortium (MSGERC) today announced the establishment of a collaboration to advance Vical’s novel antifungal drug product candidate for the treatment of invasive aspergillosis. This collaboration will combine the clinical development expertise of Vical with the specialized expertise of the MSGERC in the area of invasive fungal infections.
“We are excited to establish this collaboration with the world’s leading mycology clinicians and thought leaders,” said Dr. Mammen “Anza” Mammen, Vical’s Senior Vice President, Clinical Development. “We believe the MSGERC will add substantial value to our VL-2397 antifungal program by serving as advisors to our Phase 2 trial and helping provide exposure for the study among their member clinicians who may be interested in taking part as investigators.”
The U.S. Food and Drug Administration (FDA) has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) approval assuming a successful outcome of a single Phase 2 trial carried out in accordance with a protocol and statistical analysis plan consistent with the Agency's advice. The final determination whether the drug is approvable will be made by FDA after review of all relevant data.
The LUI is a provision of the Limited Population Pathway established under the 21st Century Cures Act of 2016. Vical plans to initiate a single Phase 2 trial for the treatment of invasive aspergillosis in acute leukemia patients and allogeneic hematopoietic cell transplant (HCT) recipients in the first quarter of 2018.
VL-2397 is Vical’s novel antifungal compound that was licensed from Astellas Pharma in 2015. VL-2397 was isolated from a leaf litter fungus collected in a Malaysian national park and represents the first agent in a potentially new class of antifungal drugs. The FDA has granted Vical Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designations for VL-2397 in the treatment of invasive aspergillosis.
About Invasive Aspergillosis
Invasive aspergillosis is a life-threatening infection that typically affects immunocompromised patients, including those with acute leukemia and recipients of allogeneic HCT or lung transplants. Infection typically starts in the lungs and rapidly disseminates to other tissues. More than 200,000 cases of invasive aspergillosis are diagnosed annually worldwide.
Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, including antiviral and antifungal candidates in clinical development. Additional information on Vical is available at www.vical.com.
The Mycoses Study Group Education & Research Consortium is a non-profit organization dedicated to providing continuing medical education and scientific/medical thought leadership for evidence-based medicine in the diagnoses, prevention, treatment and maintenance of patients at risk for or afflicted with invasive fungal infections. This organization will also serve as a resource and support for patients and caregivers who are affected by these serious rare diseases. This group’s mission includes setting the annual educational and research agendas for mycology and providing top-quality continuing education initiatives to MSG-member institutions and to other institutions and practitioners throughout the United States and globally.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include anticipated developments in clinical programs, including the plans, timing of initiation, and enrollment for clinical trials, and expected benefits of the collaboration between Vical and MSGERC. Risks and uncertainties include whether Vical or others will continue development of VL-2397; the risk that the collaboration between Vical and MSGERC is terminated earlier than expected or does not result in expected benefits to the development of VL-2397; the risk that the FDA does not grant LUI approval of VL-2397 following the results of Vical’s planned Phase 2 clinical trial; whether Vical will be able to obtain regulatory allowances or guidance necessary to proceed with proposed clinical trials or implement anticipated clinical trial designs; whether on-going or planned clinical trials will be initiated or completed on the timelines Vical currently expects; whether any product candidates will be shown to be safe and efficacious in clinical trials; the fact that results from the planned Phase 2 clinical trial of VL-2397 may be inconsistent with the results from prior preclinical studies and clinical trials; whether Vical will have access to sufficient capital to fund its planned development activities; whether Vical will seek or gain approval to market any product candidates; and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.