Edition 5 June 2022

An Unseen Cost of the Ukraine War

Previously Ukraine was a highly attractive location for clinical trials offering numerous distinct advantages for International Sponsors. However, research in Ukraine has become nearly impossible due to the war, which has already resulted in over 200 attacks on medical facilities. The medical infrastructure of Ukraine is being destroyed, which means that potentially life-saving research is being disrupted. Cromos Pharma’s CEO, Vlad Bogin, was interviewed by Spotlight on America as part of its investigative report on the situation with clinical trials in Ukraine. Please read the story and watch the video here.

Conducting Clinical Trials in the Czech Republic

The Czech Republic is a well-established location for the conduct of clinical trials with a strong track record in producing high quality data. In recent years it has developed a reputation as an attractive location for niche clinical trials including those for gene and cell therapies, as well as for rare diseases. The Czech Republic offers numerous distinct advantages for International Sponsors including excellent recruitment potential, centralized Universal Healthcare System, large network of public hospitals and clinics, and full compliance with ICH-GCP.

For more details on clinical trials in Czech Republic, please read our country profile here .

Myeloma Survival

A new potential standard of care for patients with relapsed multiple myeloma has resulted from the Phase III Ikema clinical trial. Scientists have found that Sarclisa, in combination with carfilzomib and dexamethasone (Kd), helps to prevent disease progression among patients with multiple myeloma for nearly three years. The new treatment apporach demonstrated a median progression free survival (mPFS) of 35.7 months, compared to 19.2 months in patients treated with Kd alone. This study shows unprecedented results for Sarclisa making it potentially the best in class anti-CD38 antibody. Read more here.

Vaccine Candidate against three Mosquito-borne Encephalitis Viruses

Three mosquito-borne encephalitis viruses: eastern equine encephalitis virus (EEEV), western equine encephalitis virus (WEEV) and Venezuelan equine encephalitis virus (VEEV) can potentially be prevented by the WEVEE vaccine, as shown by a recent Phase I clinical trial. EEEV, WEEV and VEEV are spread to humans through mosquito bites. These diseases are rare but can lead to severe neurological damage or death. The vaccine candidate was developed by NIAID VRC, part of the US National Institutes of Health. Studies have proven the safety of the vaccine, as well as good tolerability and high efficacy against all three viruses. Read the article here.

Antiviral Drug Development Awarded by NIH

The National Institute of Allergy and Infectious Diseases (NIAID) awarded $577 million to create 9 Antiviral Drug Discovery Centers for Pathogens of Pandemic Concern. The program is initiated as a part of the Antiviral Program for Pandemics (APP).

The main goal of the project is to prevent future pandemics caused by various viruses. The research will include the development of COVID-19 antivirals, as well as antivirals targeting specific viral families with high potential to cause a pandemic. “The COVID-19 pandemic has highlighted the need for new antiviral drugs, especially those that could easily be taken by patients at home while their symptoms are still mild,” said NIAID Director Anthony S. Fauci, M.D. Read more here.

Retinal Cell Map for the Treatment of Blinding Diseases

Scientists from the National Eye Institute (NEI) have identified 5 subpopulations of retinal pigment epithelium (RPE). Researchers used Artificial Intelligence to analyze images of RPE, at single-cell resolution, to create a reference map that locates each subpopulation within the eye. “The findings will help us develop more precise cell and gene therapies for specific degenerative eye diseases,” said the study’s lead investigator, Kapil Bharti, Ph.D., who directs the NEI Ocular and Stem Cell Translational Research Section. Read the full article here.

Clinical Trials Navigator

AmerisourceBergen (AB) has introduced a new suite for biopharmaceutical clinical trial recruitment, called ‘Clinical Trial Navigator’. It uses such tools as digital site selection, patient detection and enrollment for oncology trials.

Biopharmaceutical firms can enter crucial protocol criteria within the Clinical Trial Navigator suite to detect appropriate practice sites, and their ideal subject populations. This practice will help biopharmaceutical companies gain a holistic view of independent specialty practices and their patient populations. Read more here.

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