The following Talking Points are submitted to help in understanding our USDA approved immunomodulator for domestic animals under the Veterinarian Biological Product License dated April 29, 2002. The product is currently manufactured by the Colorado Serum Company under the name Pulmo-Clear and prescribed by Veterinarians per label for use in treating Equine Lower Respiratory Disease.
Pulmo-Clear has been used off-label by various veterinarians to treat other previous non treatable conditions in both large and small animals. The results are treated as antidotal and were not part of a clinical trial or supported by the manufacturer, Colorado Serum Company.
The active ingredient in Pulmo-Clear is the only known biological response modifier that affects and modulates both the innate and adaptive immune systems without negative side effects. It does this by resetting the immune system so that the body can heal itself. It also works to make other treatments more effective.
Conditions Treated by Pulmo-Clear™
Based on the research work, trials and antidotal evidence in humans and some antidotal evidence in animals, we believe Pulmo-Clear™ can be used to therapeutically treat the following partial list of conditions:
Respiratory disease and pneumonia
Various Therapeutic Resistant Cancers
Parvo in dogs
Chronic AutoImmune Diseases
Primary immunodeficiencies
Chronic Pain
Irritable Bowel Syndrome (IBD) and Ulcerative Colitis
Tick-borne diseases
Enlarged Heart (Dilated Cardiomyopathy) in Dog
Current status of Pulmo-Clear
The patent and intellectual property for Pulmo-Clear™ were purchased in 2005 by private individuals to facilitate work on the human product. The human product, NPIS40/INFEPERIUM, is owned by a separate legal entity from Pulmo-Clear.
One of the original patent holders on the Vet product, Dr. Kenneth Willeford from Mississippi State University is also working on the serum for humans, which is finished and approved for human use in research for homeopathic treatment in South Africa and has started the process for approval in Mexico. It has been proven effective in treating previously non-treatable chronic diseases.
Since both animals and humans have the same innate and adaptive immune systems, we believe what we have discovered for humans to be true for animals. Both the human and vet product have the same active ingredient.
Pulmo-Clear™
Pulmo-Clear™ is an aid for the treatment of ELRD (Equine Lower Respiratory Disease).
Efficacy studies demonstrate that Pulmo-Clear™, when used with adjunctive therapy, successfully clears Equine Lower Respiratory Disease (ELRD), leading to increased recovery rates and reduce recovery times in affected horses. In fact, combined data from field studies show that Pulmo-Clear helps promote an overall ELRD recovery rate as high as 86 percent.
To address the faulty or improper immune response to the agents that cause ELRD, Pulmo-Clear™ works to modulate the immune system - allowing the horse improved recovery from the clinical conditions associated with the disease.
Note: The addition of Pulmo-Clear™ to antimicrobial therapy increased the recovery rate from 37.5% to 77.5%
In dose response studies, endoscopic scores were part of clinical evaluations for each presenting horse. A diagnosis of lower airway disease was based upon history, clinical examination and endoscopic findings of exudates in the trachea. An endoscopic score was used to describe the amount, physical characteristics, and location of the tracheal exudates. Higher endoscopic scores indicated more severe disease.*
*Data on file with USDA
** p<0.05 versus placebo group
Contraindication: Corticosteroids and other drugs which may cause immunosuppression are not recommended for use with this product.
Directions: Store at 2° to 7° C. Do not freeze. Use entire contents when first opened. Do not vaccinate within 21 days before slaughter.
Precautions: Anaphylactoid reaction may occur following administration of products of this nature. If noted, administer adrenalin or equivalent.In the event of accidental human exposure, consult a physician.
Dosage and Administration:
Inject one 2ml. dose deep intramuscularly in the neck. Repeat this dose in 7-10 days in the opposite side of the neck. Moderate exercise aids in preventing or reducing local reaction. Discontinue use if a severe local reaction occurs. Pulmo-Clear™ is restricted to use by or under the direction of a Veterinarian. Pulmo-Clear™ is a biological product.
General Information:
This product is a patented sterile filtered fraction of serum from pre-tested goats. Fraction is purified and standardized to assure uniformity of product. Response in treated horses is of an immunomodulating nature.
Directions when to vaccinate: Do not vaccinate within 21 days before slaughter.
Precautions: A systemic anaphylactic reaction is always possible after administration of a product of this nature. Discontinue use of this product and administer adrenalin or equivalent if an anaphylactic reaction occurs.Protein-containing serum origin products may cause local reactions. These can include local swelling with increased heat at the injection site. Studies have demonstrated that these reactions are transient and usually recede within 48-72 hours. Rarely they may last longer. Moderate exercise aids in preventing or reducing local reaction. Discontinue use if a severe local reaction occurs.
Indications and Information: Proper diagnosis, selection of treatment modalities, and follow-up examinations for Lower Respiratory Disease in equines require veterinary expertise. Therefore, it is recommended that Pulmo-Clear™ be used by or under the supervision of a veterinarian.
Pulmo-Clear™ is recommended for use as an aid in combination with adjunctive therapy in treatment of horses with lower respiratory disease. This problem often occurs in athletic horses involved in racing, rodeo, jumping, endurance and other stressful exercise. When horses become ill, performance is reduced and they are usually removed from competition, often for an extended time period.
Efficacy testing included evaluation of recovery as measured by improvement in clinical signs and reduction and/or elimination of exudate of the trachea and lower respiratory tract by bronchoscope exam. These tests demonstrated a significant reduction in recovery time for horses receiving Pulmo-Clear™ and adjunctive therapy when compared with horses receiving only adjunctive therapy.
Field safety testing included groups of horses from 6 months to 15 years of age.
Contraindication: Corticosteroids and other drugs which may cause immunosuppression are not recommended for use with this product.
USDA Code: 9360.00
U.S. Vet. License No. 188
Pulmo-Clear™ comes in a package consisting of 10 vials filled with 2 ml each.
