Field safety experience with an autologous cancer vaccine in tumor-bearing cats: a retrospective study of 117 cases (2015-2020).

OBJECTIVES: The aim of this study was to determine the frequency and severity of adverse events (AEs) reported from use of an adjuvanted whole-cell autologous cancer vaccine in cats with solid tumors under field conditions. METHODS: The case accession database at Torigen Pharmaceuticals was searched to identify client-owned cats that underwent biopsy or surgical resection of their primary tumor, had histologic confirmation of neoplasia and received at least one subcutaneous dose of an adjuvanted whole-cell autologous cancer vaccine. Records were reviewed for any reported AEs. RESULTS: In total, 117 cats met the inclusion criteria and received 422 doses of autologous cancer vaccine. Six (5.1%) cats had seven reported AEs, with the majority of these (85.7%) being characterized as grade 1 or 2 (mild) and resolving without medical intervention. CONCLUSIONS AND RELEVANCE: AEs were infrequent in cats treated with an adjuvanted whole-cell autologous cancer vaccine under typical field use conditions. This form of active cancer immunotherapy appears to be well tolerated by cats and may represent a treatment option for owners who are concerned about AEs associated with chemotherapy or radiotherapy. Additional studies are warranted to determine the efficacy of this form of individualized immunotherapy in cats with solid tumors.

Non-lesional cerebellar damage in patients with clinically isolated syndrome: DTI measures predict early conversion into clinically definite multiple sclerosis.

Background: Today, no specific test for the diagnosis of multiple sclerosis (MS) is available due to the lack of characteristic symptoms at beginning. This circumstance also complicates estimation of disease progression. Recent findings provided evidence for early, non-lesional cerebellar damage in patients with (clinically definite) relapsing-remitting MS. Objective: To investigate if microstructural cerebellar alterations can also serve as early structural biomarker for disease progression and conversion from clinically isolated syndrome (CIS) to MS. Methods: 46 patients diagnosed with CIS and 26 age-matched healthy controls were admitted to high-resolution MRI including diffusion tensor imaging (DTI) to examine atrophy and microstructural integrity of the cerebellum. Microstructural integrity of cerebellar white matter was assessed by fractional anisotropy (FA) as derived from DTI. Results: Although all 46 patients of our CIS cohort showed no cerebellar lesions in structural MRI (T1w, T2w, FLAIR), their mean cerebellar FA was already reduced compared to healthy controls. Significant FA reduction at follow-up DTI 6 months after baseline examination was observed. In 16 patients that converted to MS, we found a correlation between initial cerebellar FA and conversion latency (R = 0.71, p < 0.002). Initial cerebellar FA under FAcrit = 0.352 predicted conversion into relapsing-remitting MS within 24 months (FAcrit: mean cerebellar FA of patients with early MS, determined in another study). Conclusion: DTI seems to reflect early tissue injury in beginning MS, when atrophy and lesions are not yet detectable. Decreased cerebellar FA in patients with CIS might indicate an active and unstable disease stage, resulting in a shorter conversion time into MS.

Impact of changed legislation on skin tests: the present and future.

PURPOSE OF REVIEW: To discuss the impact of current European Union regulations on the availability of commercially available skin test allergens in European member states. RECENT FINDINGS: European Union legislations now define diagnostic allergens to be medicine requiring market authorization of every individual diagnostic allergen with obligations including clinical trials, application dossiers, a regular update of the dossiers, handling of variation processes and ongoing stability testing of the source material and periodic safety update reporting. The financial expenses of the initiation and maintenance of approvals for diagnostic allergens far exceed their related revenues. Thus, the numbers of authorized test allergens are steadily decreasing. SUMMARY: The current European Union regulations are anticipated to have an immense impact on in-vivo allergy diagnosis in Europe. Available skin test allergens decreased to less than half of what has been before in recent years. EAACI has addressed both the EU and EMA to resolve this situation.