Clinical Trial Results
Clinical Trial Results Overview
Date: 5/10/09
Investigators:
Demian Dressler, DVM
Aarti Sabhlok, DVM. Board Qual., Oncology
Cathy Johnson-Delaney, DVM, Dipl. ABVP
Mark Thomas, DVM, Dipl. ABVP
Trial Protocol
Dogs were qualified for the trial on the basis of not having received chemotherapy, radiation, nor surgery. Concurrent use of NSAID drugs was prohibited, or other medications or therapies that could likely confound results. Flea, tick, and heartworm preventative, vitamins and antibiotics were allowed for health maintenance during the trial period. Similarly, neutraceuticals such as fatty acid supplements, lecithin, or chondroprotective joint supplements were allowed.
Dogs were admitted into the trial, examined, and baseline CBC, Serum Chemistries, Electrolytes, and T4 values were obtained. Biopsies for pathology reports and aspirates for cytology were performed before the use of ApocapsTM. Blood work, cytology, and pathology reports were obtained from Antech Diagnostic Laboratory, an independent commercial veterinary reference laboratory located at 2433 Cove Rd. Southaven MS 38671. Dogs were then given ApocapsTM at a dose of no more than 2 capsules per 40 lbs three times daily on an empty stomach or with a small amount of food. CBC’s, Serum Chemistries, Electrolytes, and T4 values were repeated at 10, 21, and 66 days of use minimally. Serial measurements were taken with a tape measure in two dimensions for external masses, and imaging techniques were used for internal tumors. Owner feedback was obtained to determine the adverse effects observed by owners during the treatment period.
Definitions and details
Confirmed Malignancy: Malignant neoplasia confirmed by biopsy or fine needle aspirate cytology with unaffiliated pathologist review. In the case of the liposarcoma, fine needle aspirate yielding adipocytes combined with rapid growth atypical of lipoma indicated malignancy.
Confirmed Benign Growth: Benign neoplasia confirmed by biopsy or fine needle aspirate. Biopsies and fine needle aspirate cytology were reviewed by unaffiliated pathologist. In the case of fine needle aspirates yielding adipocytes however, the cytology review of fine needle aspirates was conducted by Dr. Dressler.
Indeterminate Growth: Grossly observable masses that were not definitively diagnosed by biopsy or fine needle aspirate cytology.
Tumor: All grossly observed, solid tissue masses in the shape of a directly visible or palpable growth, presumed benign or malignant, or pathologist-confirmed malignancies. Non-neoplastic growths such as abcesses, cysts, etc. were excluded.
Measureable benefit: Determined at least 1 week beyond starting treatment but prior to 66 days of continued use of ApocapsTM. In the case of Confirmed Benign or Indeterminate Growths groups, a measured decrease in size was found during the treatment period. In the case of the Confirmed Malignancies group, the following criteria dictated a measureable benefit was achieved:
- A measured decreases in tumor size was documented during treatment period
- A total cessation of previous known growth was observed during the treatment period
- Survival time of patient exceeded known median life expectancy during or beyond the treatment period
Dogs who were euthanized, or who passed away due to malignant neoplasia or other documented disease were included in the Total Dogs Treated group. Also included in this group were dogs where owners abandoned use of ApocapsTM and opted for surgery. If measureable benefit due to the use of ApocapsTM was not noted in these dogs, they were included in the Total Dogs Treated group but excluded from the Measureable Benefit groups. In other words, they were counted in the group that did not respond to ApocapsTM treatment.
Treatment Period: Up to 66 days of use of ApocapsTM at doses not exceeding 2 capsules per 40 lbs of body weight three times a day. In the case where median survival times exceeded treatment period, treatment was continued beyond median survival times.
Safety Group: Adverse effects were measured via serial CBC, Serum Chemistries, T4 (before starting ApocapsTM, and at days 10, 31 and 66 of use). Owner-reported history and intermittent physicals contributed to the assessment. The majority of these dogs displayed orthopedic difficulty, which was a potential Apocaps TM application of interest to the investigators. Owner-reported benefit was determined by owner comments relating to relief of orthopedic discomfort. There was no placebo group.
Pending Group: Dogs currently enrolled in trial and being treated who have not yet completed 66 days of treatment.
Lost to Follow Up: Investigators were unable to contact owners of dogs already enrolled in trial.
Pilling Difficulty: Dogs with behavioral traits making dosing of ApocapsTM incomplete.
Adverse Effects: clinically relevant abnormalities detected on CBC’s, Serum Chemistries, Electrolytes, or T4 values. Also used was owner information such as reported lethargy, anorexia, decreased appetite, vomiting, diarrhea, or other undesirable effect. These were attributed to the effect of Apocaps temporally, or by excluding commonly known side effects of diseases ongoing during the trial period. This commonly known side effect exclusion was determined on the basis of knowledge shared among experienced licensed veterinarians.
Data Summary
Group: # Patients # Measureable Benefit
Pathologist-Confirmed Malignancy 11 4
% of group with Measureable Benefit: 36.4
Confirmed Benign/Indeterminate 11 5
% of group with Measureable Benefit: 45.5
# Patients # Adverse Effects
Safety/Orthopedic Benefit 9 2
% of dogs with Adverse Effects: 6.4
# Patients # Reports of Orth. Benefit
Safety/Orthopedic Benefit 9 7
% owners report. Orth. Benefit: 77.8
Miscellaneous Groups # Patients
Dogs Lost to Follow Up 8
Dogs with Pilling Difficulty 1
Dogs In Trial but Incomplete 3
Dogs Completed Trial with Data Pending 3
Totals
Total Dogs Treated 28
Total Dogs Enrolled in Trial 46
Individual Patients by Outcome
CONFIRMED MALIGNACY
Measureable Benefit Diagnosis
Sebastian Hanno Fibrosarcoma
Bump Snyder Lymphosarcoma
Kai Deshon Hemangiosarcoma
Mac Mounts Liposarcoma
No Benefit Diagnosis
Rosie Hall Lymphosarcoma
Chester Bear Auletta Lymphosarcoma
Chomo Jalbert Oral malignant melanoma
Dotty Figuera Grade 3 mast cell tumor
Wylie Gable Epitheliotropic lymphosarc.
Duck Bachman Hemangiopericytoma
Muttley Chiesa Ameloblastoma
CONFIRMED BENIGN/INDETERMINATE
Measureable Benefit Diagnosis/Description
Ehu Kong Plasmacytomas, Lipoma
Buddy Molina Splenic mass, liver nodules
Excalibur Ah Koi Cutaneous Hemangiosarc.
Kawena Pate Lipoma
Lia Larson Presumptive hemangiosarc.
No Measureable Benefit Diagnosis/Description
Sunshine Farber Lipomatous growths SQ
Pua Grodin Mammary Duct. Adenoma
Adam Hyatt Cutaneous Hemangiosarc.
Michellin Hyatt Hemagioma
Buddy D’Orsay Skin growth, bone mets
Puma Jones Invasive nasal sinus tumor
SAFETY/ORTHOPEDIC
No Adverse Effects Reported Orthopedic Benefit?
Mai Tai Marteney Yes
Jasmine Thomas Yes
Baby Perkins Yes
Blue Melzer Yes
Jake Nelson Yes
Roxy Heller Yes
Scout Clark Yes
Adverse Effects Description
Daisy Frahm Vomiting, diarrhea, anorexia
Lakota Wick Vomiting, anorexia
MISC. GROUPS
Dogs with Pilling Difficulty
Bert Lucia
Dogs in Trial but Incomplete Group
Jeb Hayes
Pono Martinson
Dasher Creton
Dogs Completed Trial with Data Pending
Patient data not received for 3 dogs at this time
