Prescott, AZ. – (January 24^th, 2012)   Imulan BioTherapeutics, LLC (IMULAN) has strengthened their intellectual property position from a recently awarded composition of matter patent.  The patent was issued on IMULAN’s licensed T-cell receptor (TCR) peptide therapeutics, which are classified as immuno-biologics.  IMULAN holds the global veterinary license to the TCR peptides, which are undergoing formal trials for canine atopic dermatitis and feline stomatitis.   Although IMULAN has remained focused on atopy and stomatitis, they are preparing to evaluate the TCR peptides for keratoconjunctivitis sicca (dry eye), feline leukemia virus and feline immunodeficiency virus infections, fungal infections, and cancer. 

The TCR peptides modulate the immune system and have been shown to restore normal T-helper cell function in a variety of models.  T-helper cells can be classically divided into 3 subsets (Th1, Th2, and Th17) and produce cytokines which further drive immune responses.  When T-helper cell activity gets out of balance, this can lead to a variety of diseases and conditions.  IMULAN’s TCR peptides have several key properties, including a long duration of effect, convenient subcutaneous administration, ease of manufacturing, and proposed applications for veterinary dermatology, ophthalmology, infectious disease, immune mediated disorders, and oncology.

The T-cell receptor peptides were discovered by immunologists examining how the immune system shifted with aging, infection, and other events.  The same work revealed a series of autoantibody derived peptides that could reverse or restore the normal immune balance.  This same immune shift is now known to occur in a variety of animal diseases including atopic dermatitis, stomatitis, infections, cancer, and a certain immune mediated disorders.  IMULAN has identified a lead TCR peptide for canine atopic dermatitis, feline stomatitis, infections, and cancer.

About IMULAN: IMULAN develops unique, precision immune regulating compounds for veterinary medicine.  IMULAN’s primary focus is on immunological strategies to treat infectious, autoimmune, and immune mediated diseases in small and large animal medicine.  For more information, visit www.IMULAN.com.

Daniel Gingerich DVM, IMULAN’s Chief Scientific Officer stated, “We are pleased to receive a grant from the American Kennel Club to continue our work in canine atopy.  The therapeutic vaccine appears to be a very promising approach in dogs with moderate to severe atopy.  The vaccine works by modulating over-responsive immune cells, thereby approaching the skin condition at the underlying immunological source of the problem.”

Canine atopic dermatitis is a prevalent condition in dogs affecting up to 5% of the dog population.  Atopic dermatitis in dogs is comparable to human atopic dermatitis and eczema, including alterations in immune profiles and sensitivity to allergens.  Clinical signs of atopic dermatitis include pruritus (itching) and an increase in topical skin infections such as staphylococcal pyoderma.  The T-cell receptor peptides are a new class of immunobiologic that modulates T-helper cell function and increases cell mediated immunity.  IMULAN’s TCR peptides have also been evaluated in models of retroviral infection, fungal infection, feline stomatitis, and canine dilated cardiomyopathy.  

About IMULAN: Imulan develops unique, precision immune regulating compounds for veterinary medicine.  IMULAN’s primary focus is on immunological strategies to treat infectious, autoimmune, and immune mediated diseases in small and large animal medicine.  IMULAN has active therapeutic programs for atopic dermatitis and feline stomatitis using their T-Cell receptor peptide platform.  For more information about Imulan, please visit www.IMULAN.com.

Prescott, AZ. – (January 12^th, 2011)   Imulan BioTherapeutics, LLC (IMULAN) has identified a new biomarker for atopic dermatitis.  Using dogs as the atopic model, IMULAN found a highly significant (p<0.001) increase in expression of the biomarker in atopic dermatitis subjects compared to normal subjects.  IMULAN’s Enzyme Linked Immunosorbent Assay (ELISA) found a 16-fold increase in median serum titers in atopic dogs versus normal dogs. The results are being prepared for publication.  The ELISA test is based on IMULAN’s T-cell receptor peptide platform, which is also being used to develop an immuno-therapeutic for atopic dermatitis in dogs.  IMULAN proposes to eventually commercialize combined diagnostic and therapeutic products for canine atopic dermatitis.  Patent disclosures have been filed by IMULAN regarding the unique biomarker identified in the study.

Daniel Gingerich DVM, IMULAN’s Chief Scientific Officer stated, “It has been confirmed that T-cell abnormalities represent an underlying immunological defect in atopic dermatitis. This new diagnostic detects hyper-reactivity to the dogs’ own T-cell receptors, which appears to be a characteristic of atopic dermatitis.”

Canine atopic dermatitis is a prevalent condition in dogs affecting 5% or more of the dog population.  Atopic dermatitis in dogs is comparable to human atopic dermatitis and eczema, including alterations in immune profiles and sensitivity to allergens.  Clinical signs of atopic dermatitis include pruritus (itching) and an increase in topical skin infections such as staphylococcal pyoderma.

About IMULAN: Imulan develops unique, precision immune regulating compounds for veterinary medicine.  IMULAN’s primary focus is on immunological strategies to treat infectious, autoimmune, and immune mediated diseases in small and large animal medicine.  IMULAN has active therapeutic programs for atopic dermatitis and feline stomatitis using their T-Cell receptor peptide platform.  For more information about Imulan, please visit www.IMULAN.com.

IMULAN’s Stomatitis Immunotherapeutic Shows Promise

St. Joseph, MO. – (June 22nd, 2010)   Imulan BioTherapeutics, LLC (IMULAN) announced encouraging early results from clinical trials on their T-Cell Receptor (TCR) therapeutic vaccine for feline stomatitis.  Feline stomatitis, also referred to as gingivostomatitis, is an immune mediated inflammatory condition affecting the oral cavity.  The TCR therapeutic vaccine is an immune modulating biologic that re-programs specific immune cells (T-cells) implicated in feline stomatitis.  IMULAN’s TCR therapeutic vaccine is currently being evaluated in a multi center, double blind clinical efficacy study in cats with stomatitis.

Dr. Daniel Gingerich, IMULAN’s Chief Scientific Officer stated, “Although specifics of the clinical findings are not being released, interim analysis of data from case reports received thus far are very encouraging.  The interim data are an internal milestone to allocate our resources towards focusing on our TCR vaccine program, designed to qualify for regulatory approval for feline stomatitis.”

Dr. Craig Woods, CEO of IMULAN added, “For too long, feline stomatitis has been treated with immunosuppressive drugs like steroids, which can result in diabetes and increase the risk of infections.  Since stomatitis is an immune mediated disorder, our team has focused on modulating the immune system, not suppressing immune function.  In fact, our T-cell receptor therapeutic has been shown to increase cell mediated immunity which may play a role for cats with underlying viral diseases.  If successful, this approach will usher in a brand new approach to this frustrating condition.”

About the TCR peptides: T-Cell Receptor peptides are immune modulating biologics designed to restore immune function and normalize cytokine profiles by precisely regulating T-helper cell activity.  The peptides are undergoing formal approval process for atopic dermatitis and feline stomatitis but have also evidenced promise for viral infections, cardiac disease, and fungal infections.  T-Cell receptors are the gateway to the immune system, and are responsible for recognizing substances such as peptides.  Once a T-cell receptor is activated, it triggers a cascade of cellular events that produce a systemic immune response.

About IMULAN: Imulan develops unique, precision immune regulating compounds for veterinary medicine.  IMULAN’s primary focus is on biological strategies to treat infectious, autoimmune, and immune mediated diseases in small and large animal medicine.  For more information about Imulan, please visit www.IMULAN.com.

IMULAN is now focusing on critical care applications for leukoSTAT, an environment which often has limited options to support patients. The ImSAIDs have been previously evaluated in a variety of in vivo critical care models, including sepsis (e.g. SIRS) and inflammation of the pancreas, lungs, intestines, nervous system, and joints. leukoSTAT comes in highly palatable, small, chewable tablets so that the animal can easily ingest the amino acid complex and immediately begin the process of rebalancing the immune system.

IMULAN holds the veterinary patent rights to the ImSAIDs technology platform and will be identifying partners that want to use this technology for nutraceutical use.

Imulan develops immune regulating, naturally-occurring substance for veterinary medicine. Imulan’s primary focus is to combine peptide pharmacology with immunology to manage inflammatory, infectious and immune mediated diseases in companion and production animals. Please visit www.IMULAN.com to learn more.

ImSAIDs and leukoSTAT are trademarks of IMULAN BioTherapeutics, LLC

Media Contact:
IMULAN BioTherapeutics, LLC
Heather Hurst
816-749-4016

(November 12, 2009) – Imulan BioTherapeutics, LLC (IMULAN) announced the release of LeukoSTAT™; a nutritional product containing a newly recognized class of naturally occurring amino acid complexes referred to as ImSAIDs (Immune Selective Anti-Inflammatory Derivatives). Originally discovered as important components of saliva, ImSAIDS have been shown to target leukocytes, thereby going right to the source of inflammation regardless of the cause, making it a useful product for the veterinarian. ImSAIDs have demonstrated positive effects in models of pancreatitis, sepsis, asthma, anaphylaxis, allergic reactions and spinal trauma.

Dr. Craig Woods, CEO of IMULAN, stated, “We are seeing science move away from traditional drugs which focus on blocking enzymes such as cyclo-oxygenase, towards totally natural technologies as exemplified by the ImSAIDS. Researchers can now develop products which modify the cells that make the enzymes, essentially going right to the source of the problem. This becomes a much more powerful and comprehensive tool with broad applications.”

Imulan develops immune regulating, naturally-occurring substance for veterinary medicine. Imulan’s primary focus is to combine peptide pharmacology with immunology to manage inflammatory, infectious and immune mediated diseases in companion and production animals.

Visit www.IMULAN.com or www.LeukoSTAT.com for more information.

About Feline Stomatitis: Feline stomatitis is a frustrating and prevalent condition in cats.  Although there is no known single cause of this condition, the outcome is inflammation of the oral cavity and gingival tissue.  The inflammation is a result of immune cells infiltrating the tissue and is thought to be an imbalance in a specific type of lymphocyte, called the T-helper cell.  Treatment for feline stomatitis is often limited and may consist of steroids, antibiotics, anti-inflammatories, and/or surgery.

About the TCR peptides: T-Cell Receptor peptides are immune modulating biologics designed to restore immune function and normalize cytokine profiles by precisely regulating T-helper cell activity.  The peptides are undergoing evaluation for atopic dermatitis, feline stomatitis, and various other disorders including viral infections, cardiac disease, and fungal infections.

About IMULAN: Imulan develops unique, precision immune regulating compounds for veterinary medicine.  IMULAN’s primary focus is on biological strategies to treat infectious, autoimmune, and immune mediated diseases in small and large animal medicine.  In 2008, IMULAN licensed Lymphocyte T-Cell Immunomodulator as a conditionally approved treatment aid for cats infected with feline leukemia and immunodeficiency virus.  For more information about Imulan, please visit www.IMULAN.com.

T-Cell Receptor peptides target T-helper cells: immune cells that are key players in atopic and allergic dermatitis. T-helper cells are central regulators of immune function and their imbalance is implicated in a variety of disorders including atopy, asthma, stomatitis, and various infections.

Dr. Daniel Gingerich, CSO of IMULAN, stated, “We are excited to begin our final phase of work that will be used in support of a product approval. We are currently setting up multiple centers around the country to participate in our clinical program and to help acquire the necessary data for submission.”

Dr. Craig Woods, CEO of IMULAN, states, “This is an exciting time for IMULAN, a small biopharmaceutical company focused on major diseases in veterinary medicine such as allergic skin disorders. We believe our immune modulating approach will be far superior to traditional immunosuppressive drugs and advance a brand new technology platform to market.”

Dr. Daniel Gingerich, CSO of IMULAN stated, “For the first time, we may have documented the clinical relevance of the link between immune modulation and therapeutic intervention in canine cardiomyopathy. Our findings suggest an improvement in cardiac function after immunization with our peptides, an effect that has been observed with other species. Although preliminary findings are encouraging, more work will be needed to confirm our findings and elucidate the optimal approach to this devastating disease.”

Dr. Craig Woods, CEO of IMULAN went on to state, “There is growing evidence that certain cardiac diseases are accompanied by changes in lymphocyte populations. Lymphocytes, which produce a variety of cell signals, may directly influence cardiac fibroblasts and thereby affect cardiac compensation. We are hopeful that this research will lead to major cardiovascular breakthroughs within the next few years.”

Dr. Christine Haakenson, Director of Research Program Development, AKC Canine Health Foundation stated, “I look forward to following the development of this research into a treatment that will improve the life of dogs inflicted with dilated cardiomyopathy.”

About the TCR peptides: T-Cell Receptor Peptide Vaccines are immune modulating biologics designed to regulate T-helper cell activity, including restoring immune function in aged animals and normalizing Th1/Th2 cytokine signaling profiles. The TCR peptide platform is being developed for cardiovascular, infectious disease, and immune mediated diseases. Recently, evidence is implicating the immune system as playing a role in cardiomyopathy which could lead to a new class of compounds to treat this disease.

Dr. Daniel Gingerich, CSO of IMULAN stated, “We are grateful to the American Kennel Club for their research support for diseases like atopic dermatitis. This project will examine immunological markers in blood to try and better identify patients with atopic dermatitis. If successful, IMULAN’s atopic dermatitis diagnostic could be available from IMULAN’s reference laboratory early next year.”

Dr. Craig Woods, CEO of IMULAN went on to state, “The TCR peptides appear to have a dual purpose, which can be diagnostic and therapeutic in application, similar to antigens. Creating a diagnostic for atopic dermatitis is an exciting prospect for veterinary medicine, one which may be useful in identifying the optimal treatment program for each patient.”

About Canine Atopic Dermatitis: Canine atopic dermatitis is a very prevalent condition in dogs, thought to affect up to 5% of the dog population. Dogs with atopic dermatitis are comparative to human atopic dermatitis, including alterations in immune profiles and sensitivity to allergens. Clinical signs of atopic dermatitis include pruritis (itching) and an increase in topical skin infections such as staphylococcal pyoderma.

About the TCR peptides: T-Cell Receptor peptides are immune modulating biologics designed to restore immune function and normalize cytokine profiles by precisely regulating T-helper cell activity. The peptides are undergoing formal approval process for atopic dermatitis and feline stomatitis but have also evidenced promise for viral infections, cardiac disease, and fungal infections.