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BREAKING NEWS: USDA ACCEPTS EFFICACY CLAIM FOR POLYPRENYL IMMUNOSTIMULANT


The USDA has accepted our data on the efficacy of POLYPRENYL IMMUNOSTIMULANT in reducing severity of feline rhinotracheitis. Remember that our license was issued as “conditional”?  To get the conditional license, we have satisfied very stringent requirements to SAFETY, and now the USDA has confirmed that we have met another MAJOR condition – CLINICAL EFFICACY.

WHAT DOES THIS MEAN FOR VETERINARIANS?  It means that after the USDA has reviewed data from several clinical trials, they support the claim that of POLYPRENYL IMMUNOSTIMULANT is SAFE and EFFICACEOUS in reducing the severity of rhinotrachetis.

WHAT DOES THIS MEAN FOR CAT PARENTS?  

It brings an extra peace of mind to know that the US Government known for its high standards and rigorous reviews of medicines has agreed that POLYPRENYL IMMUNOSTIMULANT is a SAFE and EFFECTIVE product.


Dr. Tanya Kuritz Joins Sass & Sass, Inc.


December 30, 2013.  Sass & Sass, Inc. is pleased to announce that in January 2014 Dr. Tanya Kuritz is joining the company as a full-time Chief Operating Officer. While she has been a co-founder and a member of our Board of Directors, she has been focusing on her career at Oak Ridge National Laboratory for the past 19 years. Dr. Kuritz brings a wealth of experience and expertise, and as we continue growing she will now dedicate all her time and talent to R&D and leadership at Sass & Sass, Inc.

Dr. Kuritz certainly knows a thing or two about R&D, management and leadershipShe invented the approach and presented proof of principle for using a plant photosystem as biological prosthesis in macular degeneration. She is a recognized expert in algal biotechnology, and has authored and co-authored numerous research papers and patents. Her management experience is evidenced by the success of many international conversion projects and R&D projects in biotechnology.

Over the past 4 years at ORNL, Dr. Kuritz has been managing a nationwide, multi-million dollar Technical Assistance Program providing assistance and training in energy efficiency and conservation, for which she has earned awards, numerous accolades and achieved a recognized impact in the area.

At Sass & Sass, Inc., Dr. Kuritz will oversee all aspects of regulatory affairs, be responsible for the research and development of new applications and products, manufacturing and for collaborative efforts, as well as developing and scaling up various production and business processes.

We are excited to have her at one of the top management position of COO (finally) and about new opportunities that will come with her leadership. Welcome Dr. Kuritz!


Distribution Now Handled by VetImmune


July 7, 2013.  Sass & Sass, Inc. is glad to announce that starting August 2013, distribution of Polyprenyl Immunostimulant will be done by VetImmune, LLC, a company dedicated to providing quality products for companion animals.  Please contact VetImmune with all inquiries regarding distribution and sales of Polyprenyl Immunostimulant. 


USDA ISSUES CONDITIONAL LICENSE FOR POLYPRENYL IMMUNOSTIMULANT


OAK RIDGE, TN, September 28, 2012–The U.S. Department of Agriculture has issued a veterinary biologics establishment license for the Sass & Sass, Inc. facilities in Oak Ridge, TN and a conditional license for Polyprenyl Immunostimulant to Sass & Sass, Inc.
 
Polyprenyl Immunostimulant is the first treatment intended to aid in the reduction of clinical signs resulting from a feline rhinotracheitis virus infection in cats 8 weeks of age or older.  Studies of the product efficacy and safety were performed in collaboration with Dr. Alfred M. Legendre of the University of Tennessee, Knoxville.
 
Feline viral rhinotracheitis is an upper respiratory or pulmonary infection also known as feline influenza.  It is caused by feline herpesvirus Type 1. This disease is highly contagious and has been reported in domestic and wild cats worldwide.  It is ubiquitous in multi-cat environments, including catteries and shelters.  Complications of feline rhinotracheitis are numerous and may include blindness and death.  Feline viral rhinotracheitis is responsible for half of all respiratory diseases in cats, making it one of the most compelling feline diseases.
 
Studies indicate that Polyprenyl Immunostimulant can reduce the severity and duration of signs of rhinotracheitis, including rhinitis and conjunctivitis.  The product is administered orally, and is recommended for use in cats at eight weeks of age or older to aid with the control of disease associated with feline rhinotracheitis virus infection.
 
USDA granted the conditional license following the acceptance of data supporting product safety and a reasonable expectation of efficacy.  The safety data included results of studies that evaluated the product both under normal conditions and in field safety trials in 390 cats in 10 states. Under the conditional license, the product may be distributed as authorized in each state, and used by, or under the supervision of, veterinarians.  

Sass & Sass, Inc. is a research-driven biotechnology company with a focus on the development and manufacturing of novel immunomodulatory treatments.  Polyprenyl Immunostimulant is a veterinary biologic which is capable of regulating immune response in viral diseases and immune disorders, including herpes and others.  Sass & Sass, Inc. holds a US Patent for the composition and methods, and another patent application is pending.  Sass & Sass, Inc. has developed process and manufactures Polyprenyl Immunostimulant from domestic raw materials; all phases of manufacturing, packaging and control are conducted by Sass & Sass, Inc. at its facility in Oak Ridge, TN.  The company has been working with the University of Tennessee Veterinary Teaching Hospital on clinical trials for feline viral rhinotracheitis, feline infectious peritonitis, and other diseases.


September 2009 - Another study, and press coverage


Dr. Alfred M. Legendre was interviewed for the “L'Action Veterinaire” a French weekly journal for veterinarians on the treatment of FIP with Polyprenyl Immunostimulant.

Sass & Sass, Inc. started field safety study in New Mexico.


August 2009 - Pre-License Facility Inspection


Sass & Sass, Inc. passed a pre-licensing facility inspection by US Department of Agriculture.

Journal of Feline Medicine and Surgery published a paper “Effect of Polyprenyl Immunostimulant on the survival times of three cats with the dry form of feline infectious peritonitis“ (J Fel Med Surg 11:624-626) by Drs. Alfred M. Legendre and J.W. Bartges.  Abstract - Feline infectious peritonitis (FIP) is considered a fatal disease. Three cats with dry form FIP were treated with Polyprenyl Immunostimulant. Two of the three cats are still on treatment and are alive and well 2 years after diagnosis. The third cat survived 14 months but was treated for only 4.5 months. Further studies are necessary to assess the potential of the Polyprenyl Immunostimulant.


July 2009 - Field Safety Study Begins


In July of 2009, Sass & Sass started a field safety study for Polyprenyl Immunostimulant.


October 2008 - USDA Conditional License


October 2008 - USDA Agrees to Grant Conditional License to Sass & Sass, Inc. for its Polyprenyl Immunostimulant.

On October 9, 2008, Sass & Sass, Inc., a research-driven biotechnology company, received notice from the United States Department of Agriculture (USDA) that the latest data for its trials of Polyprenyl Immunostimulant in cats with feline rhinotracheitis (herpes virus) are “suggestive of reasonable expectation of efficacy” and, along with earlier data, “provide adequate support for the efficacy aspect necessary for a conditional license” which will be granted upon completion of field safety trials and other standard compliance requirements.  The conditional license, when granted, will provide the Company full access to the U.S. market.

Polyprenyl Immunostimulant is a veterinary biologic with immunomodulatory properties capable of controlling a variety of viral diseases and immune disorders, including herpes and others.  Sass & Sass, Inc. holds a US Patent for the composition and methods and another patent application pending.  Sass & Sass, Inc. has developed process and manufactures Polyprenyl Immunostimulant from domestic raw materials; all phases of manufacturing, packaging and control are conducted by Sass & Sass, Inc. at its facility in Oak Ridge, TN .   The company has been working with the University of Tennessee Veterinary Teaching Hospital on animal trials for herpes, feline infectious peritonitis, and for other diseases.