SAN DIEGO, CA, USA I March 07, 2016 I 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 Vical
Vical 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 .
SOURCE: Vical
Post Views: 62
SAN DIEGO, CA, USA I March 07, 2016 I 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 Vical
Vical 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 .
SOURCE: Vical
Post Views: 62
