PILOT STUDY

Seeking diabetic dogs

We’re enrolling diabetic dogs in a pilot study for a 1-time treatment that could potentially reduce their dependence on insulin — meaning your dog could require fewer insulin injections, or no injections at all.

Gene transfer has been documented to treat diabetes in rats, mice and dogs. Some dogs treated with gene therapy have been followed for up to 8 years, with no evidence of adverse events associated with this treatment. Although gene transfer has been used successfully and safely in treating 8 research dogs with diabetes, this novel treatment has not been provided to treat privately-owned dogs living in their home environments. This is considered by the Food and Drug Administration (FDA) to be an investigational drug.

Additional information on gene transfer:

• Gene transfer for diabetes refers to the delivery of a specific virus containing an insulin gene.

• The virus used to bring the insulin gene inside cells is called a “vector”. In this study the viral vector is specifically an adeno-associated virus (AAV) which has not been shown to cause illness in humans or dogs.

• To create a gene transfer “vector,” the AAV virus genes are removed and replaced with the normal insulin gene.

• When the AAV vector carrying the normal insulin gene is injected into a dog’s vein, the vector is attracted to the liver. In the liver, the vector transfers the insulin gene into the liver cells. This new source of insulin (called recombinant insulin) is released from the liver cells into the dog’s bloodstream in response to the dog’s blood glucose levels.

• If the production of insulin is high enough, your diabetic dog might not require insulin injections.

An AAV vector containing an insulin gene, has been administered to 8 research dogs and hundreds of mice and rats with diabetes without adverse events. However, this study protocol may involve risks that are currently unforeseeable.

Placement of a small catheter in one of your dog’s veins may cause minor discomfort for a few seconds and/or result in temporary bruising of the skin. Administration of the vector is not expected to cause discomfort. If your dog becomes sick after being discharged from the clinic, you should inform the study veterinarian as soon as possible.

It is possible that your dog will require fewer insulin injections or no injections at all.

The costs of the procedures, tests, assessments, hospitalization and treatments required for the study and listed above under each scheduled study visit are covered by the study and must be performed by the study clinic only.

However, complications may happen during the study treatment because of your pet’s disease, as a result of treatment for the disease, or for unrelated reasons. You are responsible for all costs of tests and treatments, except those specifically mentioned as being included in the study.

Because the results of gene transfer treatment using an AAV vector may be permanent, and because it is important for us to observe your dog for any long-term treatment effects, your dog should be intermittently monitored for the remainder of its life. The study is scheduled to last through the Day 365 visit, approximately 1 year after the initial treatment. Any follow up visits after the Day 365 visit will be arranged by Endsulin. This study may also be stopped at any time by the study veterinarian or the study Sponsor without your consent because:

• The Principal Investigator (study veterinarian) feels it is necessary for your pet’s health or safety. Such an action would not require your consent, but you will be informed if such a decision is made and the reason for this decision.

• You have not followed study instructions.
• The Sponsor or the Principal Investigator has decided to stop the study.

If you decide to have your pet participate, you are free to withdraw your pet from the study at any time. Withdrawal will not negatively interfere with your pet’s future care.

Ask about enrolling a dog:

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GINGER GANT
Executive Administrator
+1–608-234-2958
ginger@endsulin.com