ltci: treatment aid for feline leukemia (felv), and fiv infections

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LTCI HAS ARRIVED TREATMENT AID FOR FeLV / FIV INFECTIONS

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LTCI IndicationsLTCI is an approved treatment aid for cats infected with Feline LeukemiaVirus (FeLV) and/or Feline Immuno-deficiency Virus (FIV) and the associated symptoms of lymphopenia, opportunistic infection, anemia, granulocytopenia, and thrombocytopenia.LTCI ImmunopharmacologyLymphocyte T-Cell Immune Modulator is a potent regulator of CD-4lymphocyte production and function and increases IL-2 production in animals.FeLV and FIV Field TrialLTCI has been evaluated in FeLV and FIV symptomatic cats. In a 23 cat study, three weekly injections of LTCI significantly increased lymphocyte counts and increased the quality of life as determined by clinical scores (Fig. 3). Study summary available at www.IMULAN.com.Additional efficacy studies are in progress.

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Page 1: LTCI: Treatment Aid for Feline Leukemia (FeLV), and FIV Infections

LTCI HAS ARRIVED

TREATMENTAID FORFeLV / FIVINFECTIONS

Page 2: LTCI: Treatment Aid for Feline Leukemia (FeLV), and FIV Infections

LTCI Indications

LTCI is an approved treatment aid for cats infected with Feline Leukemia Virus (FeLV) and/or Feline Immuno-deficiency Virus (FIV) and the associated symptoms of lymphopenia, opportunistic infection, anemia, granulocytopenia, and thrombocytopenia.

Lymphocyte T-Cell Immunomodulator (LTCI)

LTCI increases the production of IL-2. IL-2 is known to stimulate cytotoxic T-cell responses against viruses.

...LTCI has been shown to increase IL-2 production in the Jurkat cell line (Fig. 1). Jurkat cells are a standard cell line used to study T-cell

signaling and leukemia.

1 10 10001000

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1.8 48 hr. incubation

24 hr. incubation

LTCI Concentration (Log)

Abs

orba

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)Fig. 1: IL-2 ProductionIL-2 Production

It is now accepted that T-cells participate in the production of red and white blood cells and platelets. LTCI, a T-cell immune modula-tor, has been shown to increase RBC counts in severely anemic cats and increase lymphocyte counts.

Additionally, LTCI treatment was shown to significantly increase platelet recovery in a chemotherapy induced thrombocytopenia model in mice (Fig. 2).

Hematopoietic Properties Fig. 2: LTCI Stimulated Platelet Recovery

LTCI

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LTCI Immunopharmacology

Lymphocyte T-Cell Immune Modulator is a potent regulator of CD-4 lymphocyte production and function and increases IL-2 production in animals.

Page 3: LTCI: Treatment Aid for Feline Leukemia (FeLV), and FIV Infections

Clients depend on safe products for their pets. Veterinarians demand

safe products for treating ill patients. LTCI has completed formal

safety testing. The homology of LTCI among mammalian species,

as well as, the absence of any observed adverse events in several

animal species, suggests that LTCI has a very low toxicity profile.

LTCI Safety Data

LTCI Efficacy Data

Fig. 3: Treatment Effects of LTCI After Three Injections

p=0.003

p=0.001%

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Clinical ScoreLymphocyte Count

LTCI Has Been Shown to:

• Increase CD-4 lymphocyte function

• Increase CD-4 lymphocyte numbers

• Increase IL-2 production

• Increase red cell counts in severely anemic cats

FeLV and FIV Field TrialLTCI has been evaluated in FeLV and FIV symptomatic cats. In a 23 cat study, three weekly injections of LTCI significantly increased lymphocyte counts and increased the quality of life as determined by clinical scores (Fig. 3).

Study summary available at www.IMULAN.com.Additional efficacy studies are in progress.

Long Term DataThe long-term benefits of treatment have not been clinically established. However, several animals in the field trial that received monthly or bimonthly injections have remained symptom free for long periods. Two patients in the trial also became negative for virus by PCR analysis of bone marrow aspirate.

Lymphocyte T-Cell Immunomodulator has received a conditional license from the United States Department of Agriculture. Additional efficacy and potency studies are in progress. LTCI is manufactured by T-Cyte Therapeutics, Inc and is exclusively distributed by IMULAN BioTherapeutics.

Page 4: LTCI: Treatment Aid for Feline Leukemia (FeLV), and FIV Infections

IMULAN BioTherapeutics, LLC is a privately held bio-science company pioneering the development of precision immunomodulators for veterinary medicine. We are dedicated to delivering innovative immune based treatments for a variety of challenging and life threatening animal diseases.

Our policy is to provide veterinarians access to condi -tionally approved products for diseases where no current approved therapy is available. Using our technology platforms, IMULAN is rapidly developing new, �rst-in class biologics, that target fundamental aspects of disease by modulating the immune response and in�ammation.

IMULAN has Global Animal Health Rights to the Following Technology Platforms:

Lymphocyte T-Cell Immunomodulator (LTCI) is a poly -peptide that regulates lymphocyte and cytokine production. LTCI has been conditionally approved for FeLV and FIV infections.

Immune Selective Anti-In�ammatory Derivatives (ImSAIDs) are peptides that modulate the immune response to reduce in�ammation without the side e�ects of steroids and non-steroidal anti-in�ammatory drugs. Ongoing work in feline asthma and sepsis.

TCR Peptide Vaccines are small peptides that modulate T-helper cell activity. In a variety of studies, TCR peptides have shown the ability to restore cell mediated immunity, normalize Th1/Th2 balance, and reduced morbidity asso ciated with infections. Ongoing work includes feline immune mediated in�ammation, canine atopic dermatitis and pyoderma and canine dilated cardiomyopathy.

Clinical Signs:The most important monitoring method is clinical improve -ment. Each patient should be monitored for clinical signs associated with their infection(s) and a scoring system may be established to monitor patient progress. IMULAN has a standard evaluation form that can be provided upon request.

Complete Blood Counts (CBC): Monitoring of blood cell parameters, especially lympho -cyte and red cell counts is recommended to evaluate the subject’s progress. CBCs may be done every 2-4 weeks for patients that have lymphopenia and/or anemia.

LTCI Use and Monitoring

Company

© 2008 IMULAN BioTherapeutics, LLC

IMULAN is Dedicated to Providing Innovative Solutions to Complex Animal Diseases

IMULAN recommendsthe following generaltreatment schedule.

Month 1: Weekly injectionsMonth 2: Every other weekMonth 3+: Every 4-6 weeks or as necessary

The veterinarian may have to adjust treatment schedules based on individual patient response.

toll free (877) 892-9595visit www.IMULAN.com