Vical Initiates Phase 1 Trial of Novel Antifungal Compound VL-2397

Vical Incorporated (Nasdaq:VICL) today announced the initiation of a Phase 1 clinical trial of the company’s novel antifungal, VL-2397. The randomized, double-blind trial will evaluate safety, tolerability and pharmacokinetics of VL-2397 at single and multiple ascending doses in healthy volunteers at a single U.S. clinical site.

VL-2397 represents a potential new class of antifungal compound to address invasive aspergillosis, which causes significant morbidity and mortality in immunocompromised patients, including transplant recipients. In preclinical studies to date, it has demonstrated faster antifungal activity than marketed drugs and activity against azole-resistant fungal pathogens. Current treatment options have limited efficacy, as approximately 50-60% of allogeneic hematopoietic stem cell transplant recipients with invasive aspergillosis infections die within 12 weeks. Over the past 30 years, only one new class of antifungal drugs (echinocandins) has been introduced.

“The initiation of this trial represents an important milestone for Vical by expanding our infectious disease pipeline outside the area of vaccines,” said Vijay Samant, Vical’s Chief Executive Officer. “We are pleased that our team was able to design and initiate this trial so quickly after licensing this compound from Astellas.”

The U.S. Food and Drug Administration (FDA) recently granted Vical orphan drug and qualified infectious disease designation (QIDP) for VL-2397 for the treatment of invasive aspergillosis.

Vical intends to develop VL-2397 as a treatment for invasive aspergillosis and for infections caused by other pathogenic fungi, which may represent a meaningful commercial opportunity within the $4 billion global market for systemic antifungals.

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.

Forward-Looking StatementsThis 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 statements about the potential uses and benefits of VL-2397, the parameters and timing of the Phase 1 trial, the potential market opportunity for VL-2397 and Vical’s development plans and strategy with respect to VL-2397. Risks and uncertainties include whether Vical or others will continue development of VL-2397; whether planned clinical development of VL-2397 will continue as expected, or at all; whether the results of  clinical studies will be consistent with prior preclinical studies or will otherwise merit further development; whether Vical or its collaborative partners will seek or gain approval to market any product candidates, including VL-2397; whether Vical will be able to realize any of the potential benefits of orphan drug designation for VL-2397; 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.

 

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