Ayala Pharmaceuticals Inc (ADXS)

[ubmmg]

While searching for a field safety study for AT-014, I have stumbled into another(?) canine trial. Any thoughts?
(there is also listed a safety study followed by this trial -- just scroll down a little).

http://www.petcancercenter.org/Clinical_Trials_Current_Dogs_Bone.html

MULTIPLE LOCATIONS
Study: Evaluation of a recombinant, attenuated Listeria monocytogenes expressing a chimeric human
HER2/neu protein in dogs in the adjuvant setting for osteosarcoma
Recruitment Open until 12/31/2019

Locations:
Colorado State University (Fort Collins, Colorado)
Kansas State University (Manhattan, Kansas)
Tufts University (North Grafton, Massachusetts)
Ohio State University (Columbus, Ohio)
University of Pennsylvania (Philadelphia, Pennsylvania)

Purpose of Study:
This clinical trial seeks dogs with osteosarcoma to evaluate the safety and effectiveness of a new vaccine following standard
of care therapy. Bone cancer or osteosarcoma (OSA) is a common, highly aggressive cancer that frequently affects the
long bones of large breed dogs. Current standard of care therapy consists of surgical limb amputation plus 4 doses of
chemotherapy, given in a vein, every 3 weeks.

The immune system plays an important role in identifying and targeting cancer cells in the body. In this study, we aim to use
a new approach to stimulate the body’s own immune system to attack remaining tumor cells in dogs that have undergone
limb amputation and chemotherapy for the treatment of OSA. We will use a study vaccine, which has been modified to
express a tumor protein (HER-2/neu) that is found in many cancer cells, including canine bone cancer cells and cancer stem
cells. The hope is that when injected into the bloodstream, the vaccine stimulates the immune system to attack cells
expressing the HER-2/neu tumor protein. This approach aims to delay and/or prevent the spread of cancer (metastases)
following removal of the primary bone cancer tumor (limb amputation) and chemotherapy. Interactions with other drugs are
unknown, so it is necessary to disclose any medications (and supplements) your dog is currently taking to the oncologist. It
is strongly encouraged to eliminate all unnecessary medications. .

Inclusion Criteria:
Dogs greater than 50 pounds post-amputation surgery with histological or cytological confirmation of appendicular
osteosarcoma, which includes all long bones of the limbs (radius, ulna, humerus, scapula, femur and tibia) PRIOR to
amputation. Dogs must have measurable disease that is amendable to surgical removal via amputation and no evidence of
metastasis on physical exam, thoracic radiographs, and abdominal ultrasound. Dogs must be newly diagnosed without prior
therapy (conventional or metronomic chemotherapy, ionizing radiation, or bisphosphonates.) Dogs must not have significant
co-morbid illness (including but not limited to renal or hepatic failure, history of congestive heart failure, or clinical
coagulopathy) and certain blood work parameters must be met.

Exclusion Criteria:
Dogs less than 50 pounds with osteosarcoma on non-long bones including ribs, metatarsus, metacarpus, carpal and tarsal
bones, and digits. Dogs with evidence of metastasis or who have already undergone amputation or who have prior therapy
for osteosarcoma are excluded. Dogs with significant co-morbid illness (including but not limited to renal or hepatic failure,
history of congestive heart failure, or clinical coagulopathy) or who do not meet blood work parameters will be excluded.

Potential Medical Benefits:
Potential delay of metastatic disease.

Potential Medical Risks:
Fever, lethargy, gastrointestinal upset (vomiting, diarrhea, inappetence), cardiac arrhythmias, hyper/hypotension, low
platelet counts (blood clotting cells), high or low white blood cell counts, anemia (low red blood cells), worsening kidney
function, elevated liver enzymes, rash, sepsis, even death. This is an experimental drug that may affect your dog in ways
unknown.

Owner Responsibilities:
If you allow your dog to participate in this study, you will be responsible for having the limb amputated at UC Davis, bringing
your dog to all required study appointments, recording their rectal temperature 12 hours after your pet receives each
vaccine, reporting any side effects, and covering costs of the initial examination with the UC Davis Oncology Service, the
screening diagnostic tests, which includes blood and urine collection and analysis, chest x-rays and abdominal ultrasound
and amputation, the four doses of carboplatin (as well as the associated tests, which includes bloodwork and chest x-rays),
any costs associated with management of side effects from the Standard Therapy Phase of this study (amputation and
carboplatin chemotherapy)..

Cost:
Partially funded (owner cost >$1000).