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Auburn University Scientists to Test Anti-Tumor Properties of New Drug
May 03, 2012

The Auburn University College of Veterinary Medicine and Nuovo Biologics, a biotechnology company, have announced a collaborative research agreement to study a new anti-cancer drug which also has antiviral properties. Scientists with the Auburn University Research Initiative in Cancer at the College of Veterinary Medicine will be working with Nuovo Biologics to examine the anti-tumor properties of this new drug. These studies will look at the drug from the perspective of its interactions with cells, as well as in clinical trials in dogs with malignant melanoma, a form of skin cancer. Preliminary studies have shown that the drug appears to be safe, with no side effects and active against a wide variety of viruses.

"This agreement exemplifies how Auburn University scientists, working with biotech and pharmaceutical industries, can provide expertise to move exciting new discoveries from the laboratory into the clinic," said AURIC director Bruce Smith.

The Auburn University Research Initiative in Cancer, or AURIC, embodies the "One Medicine" concept which links human, animal and environmental health and where discoveries in one species advance health in all species. For more information on the initiative, go to auricoonline.org.

Nuovo Biologics, LLC is a Florida-based animal health company dedicated to the development of drugs, biologics and supplements to enhance animal health and wellness.

Contact: Tara Lanier, 334-844-3698, tara.lanier@auburn.edu


AMERICAN ASSOCIATION OF FELINE PRACTITIONERS (AAFP), 2011 AAFP RESEARCH AWARD
March 05, 2012

Dr. Les Mandelker, DVM of the Community Veterinary Hospital in Largo, FL has been awarded a 2011 AAFP Research Award for a Pilot Study for PANAVIRA™ for the Treatment of Feline Viral Upper Respiratory Disease.

Dr. Lester Mandelker, DVM with Dr. Jay Yourist, PhD, CEO of Nuovo Biologics, and Co-Principal Investigator will conduct this study and present their research findings at the AAFP Annual Meeting at the conclusion of the study.

The study will be conducted at rescue facilities due to the large number of animals in these facilities with Feline Viral Upper Respiratory Disease. Feline URI is perhaps the most frustrating feline illness facing shelter veterinarians, breeders, and rescue organizations. Many cats are silent carriers of the viruses that cause URI. Shelter cats are predisposed to such infections because of their proximity to multiple felines, as opposed to the limited contact in a private household.

Nuovo Biologics, the sponsor of PANAVIRA™, is testing this drug which is a new broad-spectrum antiviral for nonfood animals.


Nuovo Biologics Leases Space
January 02, 2012

Nuovo Biologics, LLC has entered into a lease agreement for 5600 square feet facility in Davie, Florida. The site will have 1700 square feet of sterile manufacturing space, 1100 square feet of cGLP laboratory space, 1200 square feet of cGMP air conditioned warehouse space with the remainder for office and common areas. The Company expects to move into the office and laboratory portion by February 15th, 2012 and have the manufacturing area completed by early in the second quarter of 2012. The custom designed facility will allow Nuovo Biologics to manufacture PANAVIRA™ its signature product, to meet FDA regulations for future studies and clinical trials.

Nuovo Biologics plans to conduct in vitro and laboratory animal research relative to the company's two Investigational New Animal Drug (INAD) numbers and future applications. The Company's long range business plan calls for production under the strictest supervision to meet all FDA regulations. Dr. Neil Ross, Vice President for Product Operations was responsible for the location selection and space design. Dr Ross said, "We are reviewing all the newest technology to allow us to produce PANAVIRA™ in accordance with the FDA's requirements and which will allow us the ability to meet our present and future production needs." The facility will have the capacity and resources for contract manufacture of similar water based sterile pharmaceutical products for veterinary use.

Nuovo Biologics, LLC is a Florida based animal health company dedicated to the development of drugs, biologics and supplements to enhance animal health and wellness.


December 14, 2011

The FDA Center for Veterinary Medicine (CVM) under the Animal Drug User Fee Act (ADUFA), has again granted Nuovo Biologics an extension of the Waiver Sponsor Fees. The current waiver is for FY 2012.

The FDA's decision to grant the fee waiver is based on the assessment that Nuovo Biologics, LLC is pursuing innovative animal drug products and technology in the development on Panavira™ (See Original Waiver of March 9, 2010).


July 27, 2011

Nuovo Biologics, LLC, has received a Minor Use Minor Species Designation (MUMS) for the treatment of local disease in stage II and stage lll oral malignant melanoma in dogs from the U.S. Food and Drug Administration for its drug Panavira™.

In a statement released by the company, Dr. Jay Yourist, CEO of Nuovo Biologics, said "This is a pivotal step in a process to bring Panavira TM to market. It is significant in that the designation qualifies Panavira for seven years of exclusive marketing rights relative to the intended use. We are excited about the prospects of beginning our clinical trials."

Under section 573(c)(1) of the Federal Food, Drug, and Cosmetic Act, this marketing exclusivity begins with the date of approval or conditional approval of Panavira™ for the designated intended use.

PANAVIRA™ is a novel peptide the company believes will prove effective against canine malignant melanoma, along with a host of other viral-related animal diseases. The company has filed several patent applications regarding its Panavira™ product.


 

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