Vical Highlights Successful Outcome of Phase 1 Trial of VL-2397 Novel Antifungal During its Research and Development Day

Vical Incorporated (Nasdaq:VICL) today held its virtual Research and Development day for investors and analysts. The company provided an update on its internal programs VL-2397 for invasive aspergillosis (IA) and the HSV-2 therapeutic vaccine.

VL-2397 – Invasive Aspergillosis

• The Phase 1 trial of its novel antifungal, VL-2397 was a randomized, double-blind, placebo-controlled trial  designed to evaluate safety, tolerability and pharmacokinetics of single and multiple ascending doses of intravenous VL-2397 in 96 healthy volunteers. Results point to a favorable safety and pharmacokinetic profile for VL-2397.
• The full data set will be presented on June 2 as one of four presentations at the ASM Microbe 2017 conference. In preclinical studies, VL-2397 has demonstrated rapid and potent antifungal activity against a range of invasive fungal pathogens, including frequently-occurring Aspergillus species, azole-resistant Aspergillus fumigatus, Candida glabrata and Cryptococcus neoformans.
• Our current plan is to conduct a Phase 2 efficacy study to evaluate VL-2397 for the treatment of invasive aspergillosis and we are working with our clinical experts and the FDA towards this objective. The FDA has granted Vical QIDP, Orphan Drug and Fast Track designations to VL-2397 for the treatment of invasive aspergillosis. Under the QIDP designation we have been able to interact intensively with the FDA on the design of the Phase 2 trial. We are exploring an expedited development pathway for VL-2397.
• The VL-2397 program featured a presentation titled “Impact of Changing Epidemiology in Invasive Aspergillosis” presented by Dr. Haran Schlamm, MD, infectious disease specialist and former Senior Medical Director at Pfizer, responsible for clinical development, medical and regulatory affairs for Pfizer’s antifungal portfolio.

HSV-2 – Therapeutic VaccineThe HSV-2 program featured a presentation titled “Is a Therapeutic Vaccine Poised to Create a Paradigm Shift in the Management of HSV-2” by Dr. Anna Wald, MD, MPH, Professor, Department of Medicine, Epidemiology and Laboratory Medicine at the University of Washington and Lead Investigator in the ongoing Phase 2 trial. The event also provided a comprehensive overview of Vical’s product pipeline which included a detailed review of our HSV-2 program given by Dr. Anza Mammen.

A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial [phone] (preferred) or [phone] (toll-free) and enter replay passcode 9084195. The call will also be archived through the events page at www.vical.com. For further information, contact Vical’s Investor Relations department by phone at [phone] or by e-mail at [e-mail].

About VicalVical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. Additional information on Vical is available at www.vical.com.

 

Contact:	
Tony Ramos
		[phone]
		Website:  www.vical.com