Spanish Agency of Medicines and Medical Devices

• From sushi and sashimi (Japan) to poke bowls (Hawaii) and ceviche (Peru), consumption of raw or undercooked fish and other seafood is becoming increasingly popular.
• Appealing as such dishes can be, they can also increase the risk of exposure to fish-borne parasites.

Tiny but troublesome stowaways

• Diagnoses of infection with Opisthorchis, a family of flatworms, are the most common, but they occur mainly in East and Southeast Asia.
• Of more global concern are those caused by some nematodes of the family Anisakidae, particularly species of the genera Anisakis, Pseudoterranova and Contracaecum.

From marine mammals to human stomachs

• The genus Anisakis comprises nine species, three of which (Anisakis simplex, Anisakis pegreffii and Anisakis physeteris) have been confirmed as zoonotic pathogens.
• These nematodes infect a wide range of marine organisms; fish and cephalopods serve as intermediate hosts, while dolphins, whales, seals and other marine mammals are the final hosts.
• Adult worms are found in the mucous membrane that lines the stomachs of marine mammals.

Stomach pain and worse

• The most typical symptoms of gastric anisakiasis include abdominal pain, nausea and vomiting within hours of ingesting the larvae.
• Other symptoms can include allergic reactions and even anaphylactic shock.
• Some workers in the fishing industry as well as cooks and other professionals who regularly deal with fish may suffer from occupational allergic anisakiasis.

Ceviche, sashimi and even pickled anchovies

• These are regions where we traditionally eat raw or undercooked fish dishes such as sushi and sashimi, ceviche and carpaccio, pickled or pickled anchovies, Hawaiian-style salmon lomi-lomi and salted herring.
• The species that are most frequently parasitised include salmon, tuna, squid, cod, hake, mackerel, mackerel, horse mackerel, blue whiting, sardines and anchovies.
• While the worms can resist pickling and smoking, semi-preserves such as anchovies and traditionally salted dried fish such as cod or mojamas involve processes that kill the parasite.
• While such methods aren’t an option for fans of sushi, sashimi, and ceviche, freezing is.

• Nes-Ziona, Israel, Feb. 23, 2023 (GLOBE NEWSWIRE) --  Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the expansion of the Company’s Phase I/II of AllocetraTM in patients with advanced solid malignancies.
• The Phase I/II multi-center clinical trial (clinicaltrials.gov Identifier: NCT05581719) has been designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra™ alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors.
• Einat Galamidi, MD., Vice President, Medical of Enlivex, stated "We are pleased with the AEMPS’ regulatory clearance to expand our clinical trial into Spain.
• We believe that AllocetraTM has the potential to provide a paradigm shift in treatment of advanced solid tumors, and we look forward to data readouts, including safety and potential indication of effect in patients, currently expected during 2023 and 2024.”

• “This CTA marks the second regulatory clearance for DB-OTO and what we believe to be the first in Europe for any gene therapy targeting otoferlin.
• “We believe DB-OTO has transformative potential for individuals with otoferlin-related hearing loss, and we intend to initiate the clinical trial in the first half of 2023.
• The Phase 1/2 dose escalation clinical trial is designed to evaluate the safety, tolerability and efficacy of DB-OTO in pediatric patients with congenital hearing loss due to an otoferlin deficiency.
• The Company intends to provide an update on the design of the clinical trial in mid-2023.

• Viralgen is now licensed for the commercial manufacturing of recombinant adeno-associated virus (rAAV) gene therapies up to 2,000 liters and has completed seven successful runs at this maximum scale.
• This first phase of the expansion of the new facility, which has added 300,000 square feet of clinical and commercial rAAV manufacturing, is now complete.
• The new facility currently has three independent state-of-the-art quality control labs and commercial manufacturing suites with 500- and 2,000-liter single-use bioreactors.
• Viralgen is a fully integrated company, which supplies research, cGMP and commercial grade material from 250 to 2,000 liters in scale, including process development, formulation and filling.