IMULAN’s Stomatitis Immunotherapeutic Shows Promise

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.

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LeukoSTAT Supplement Focuses on the Critical Care Environment

April 01, 2010 - IMULAN BioTherapeutics’ new product leukoSTAT, is the first veterinary nutritional product containing the Immune Selective Anti-Inflammatory Derivatives (ImSAID ). This new technology uses naturally occurring amino acid complexes which evolved to regulate leukocytes, the source of all inflammatory processes. These specific amino acid sequences in leukoSTAT have been shown in numerous published studies to attenuate the over activation of the immune system, the underlying cause of all acute and chronic inflammatory conditions. IMULAN intends to evaluate leukoSTAT in a variety of settings to better understand its broad applications in veterinary medicine.

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

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IMULAN Launches LeukoSTAT™; ImSAIDS® – Based Technology

(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.

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IMULAN to Present Feline Stomatitis Data at 2009 Veterinary Dental Forum

St. Joseph, MO. – (October 21st, 2009)   Imulan BioTherapeutics, LLC (IMULAN) has been selected to present their most recent findings on feline stomatitis at this year’s Veterinary Dental Forum.  The session entitled “T-Cell Receptor Peptide Technology for Feline Stomatitis” will be presented by Dr. Craig Woods.  The T-Cell Receptor (TCR) technology, a biologic immune modulator, is being developed by IMULAN for immune based disorders including stomatitis.  Feline stomatitis, often referred to as lymphocytic plasmacytic stomatitis or gingivostomatitis, is a disorder that results in oral inflammation.  The TCR technology affects T-helper cells, which are immune cells implicated in feline stomatitis. 
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. ###
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IMULAN Expands Veterinary apSTAR Cancer Program

Imulan BioTherapeutics, LLC has extended the term of their exclusive license agreement with ImmunoPhotonics Inc.; for the veterinary cancer laser system based on on-going clinical trials in dogs and cats. The new portable laser device, termed apSTAR (Autologous Patient Specific Tumor Antigen Response), uses a specific wavelength to activate an immune response against the tumor cells. IMULAN’s subsidiary, Veterinary Cancer Therapeutics, is focused on hemangiosarcoma, fibrosarcoma, mast cell tumors, melanoma, osteosarcoma, and other prevalent cancers in dogs, cats and horses. In previous in vivo cancer models, apSTAR has shown the ability to induce long term tumor immunity and improve primary and metastatic tumor regression.Immunophotonics, Inc. was established in 2008 by a team of experts in laser physics and immunotherapy as a US-based research-oriented company whose main objective is to develop and introduce Laser-assisted Immunotherapy, a promising new treatment method for metastatic tumors.

Imulan develops unique, precision immune regulating compounds for infectious, autoimmune, and immune mediated diseases in small and large animal medicine. For more information about Imulan, please visit ,a href=”http://www.imulan.com”>www.imulan.com.

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IMULAN to Present Feline Stomatitis Data at 2009 Veterinary Dental Forum

St. Joseph, MO. – (October 21st, 2009)   Imulan BioTherapeutics, LLC (IMULAN) has been selected to present their most recent findings on feline stomatitis at this year’s Veterinary Dental Forum.  The session entitled “T-Cell Receptor Peptide Technology for Feline Stomatitis” will be presented by Dr. Craig Woods.  The T-Cell Receptor (TCR) technology, a biologic immune modulator, is being developed by IMULAN for immune based disorders including stomatitis.  Feline stomatitis, often referred to as lymphocytic plasmacytic stomatitis or gingivostomatitis, is a disorder that results in oral inflammation.  The TCR technology affects T-helper cells, which are immune cells implicated in feline stomatitis. 

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.

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IMULAN Prepares To Initiate Trials For Atopic Dermatitis In Dogs

IMULAN BioTherapeutics, LLC announced they are prepared to commence with regulated trials to complete work on the T-Cell Receptor peptide immunomodulator, for atopic dermatitis in dogs. Canine atopic dermatitis is a very prevalent condition in dogs, thought to affect up to 5 percent of the dog population. Clinical signs of atopic dermatitis include pruritus (itching) and an increase in topical skin infections such as staphylococcal pyoderma. The T-Cell Receptor peptides have previously shown significant improvement in dogs with severe atopic dermatitis.

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.”

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IMULAN Licenses Breakthrough Cancer Technology from IMMUNOPHOTONICS

 

St. Joseph, MO. – (June 9th, 2009)   Imulan BioTherapeutics, LLC (Imulan) announced they have licensed the exclusive global veterinary rights to a breakthrough, patented laser technology from ImmunoPhotonics Inc. for cancer treatment.  The new laser device, termed apSTAR after Autologous Patient Specific Tumor Antigen Response, induces a potent immunological response to tumor cells and their antigens, thereby provoking long term tumor immunity and improving primary and metastatic tumor regression.  Imulan recently announced the formation of Veterinary Cancer Therapeutics, their oncology division, which has already started establishing cancer centers around the country using the apSTAR medical device technology.

 Dr. Craig Woods, CEO of Imulan and Veterinary Cancer Therapeutics, stated, “We are very excited to be working with ImmunoPhotonics to advance this oncology breakthrough.  With this collaboration, we are standing on the edge of changing the general approach to cancer treatment.  The data are astonishing and should have a major impact for veterinarians in the near future.  apSTAR will help shift the emphasis towards immune-based therapies and away from cytotoxic drug or radiation therapy for many types of cancer.”

Dr. Tomas Hode of ImmunoPhotonics, Inc. stated, “We are very pleased to have formed this collaboration with IMULAN. Our method is showing wonderful results and is very soon ready to be released on the market. IMULAN is a company with a very strong portfolio and is a frontrunner in the field, so we could not have found a better partner with whom to launch this exciting new product.”

About apSTAR: apSTAR is a patented medical device technology that employs a specific laser wavelength to liberate tumor specific antigens and activate an immune response against the tumor cells.  Numerous published studies have shown apSTAR to improve the rate of primary and metastatic tumor regression and induce long term tumor immunity.  The apSTAR device is available on a limited basis in the United States, with full scale production scheduled for later this year.

About ImmunoPhotonics, Inc: Immunophotonics, Inc. was established in 2008 by a team of experts in laser physics and immunotherapy as a US-based research-oriented company with a main objective to develop and introduce Laser-assisted Immunotherapy, a promising new treatment method for metastatic tumors. 

 

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IMULAN Reports Positive Findings for Canine Dilated Cardiomyopathy

St. Joseph, MO. – (May 12th, 2009)   Imulan BioTherapeutics, LLC (IMULAN) announced encouraging echocardiographic findings from a recent pilot trial using their T-Cell Receptor (TCR) peptides for canine dilated cardiomyopathy.  The study was supported by a grant from the American Kennel Club Canine Health Foundation and conducted by veterinary cardiologists in dogs with stable but confirmed dilated cardiomyopathy.  Previous work in mice and turkeys demonstrated IMULAN’s TCR peptides have profound effects on infectious and drug-induced cardiomyopathy, and appear to induce remodeling of cardiac tissue by modulating the immune system.  Larger studies are being designed to further investigate these findings.

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.

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IMULAN Receives AKC Grant to Develop Atopic Dermatitis Diagnostic

Prescott, AZ and St. Joseph, MO. – (April 1, 2009)   Imulan BioTherapeutics, LLC (IMULAN) announced they received a grant from the American Kennel Club Canine Health Foundation entitled “Development of a Diagnostic Method for Canine Atopic Dermatitis”.  This grant is based on IMULAN’s T-Cell Receptor (TCR) peptide technology platform, the same platform being used to develop a therapeutic vaccine (immunomodulator) for canine atopic dermatitis.  Recently, IMULAN completed a study demonstrating that vaccination with their TCR peptides significantly improved the clinical status of dogs with severe atopic dermatitis.

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.

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