Study of first phase in oncology: first patient enrolled in first therapeutic applications in human on july 2, 2018

In June 2018, the GHPSJ received authorization from ARS (Agence Régionale de Santé) to establish a biomedical research site within the oncology department to conduct phase I clinical trials.

On July 2, 2018, our medical oncology department enrolled a very first patient in the study of sponsor Genoscience Pharma (N ° clinical trial: NCT03316222) for a first administration in humans of an innovative treatment.

This clinical trial concerns the GNS561 molecule, administered orally with a new mechanism of action for patients with liver cancer.
GNS561 mainly works by causing the death of cancer cells by their depletion of zinc, an essential element for the survival of cancers.
Find all information about this trial by clicking here.

 

https://www.clinicaltrials.gov/ct2/show/NCT03316222?term=genoscience&rank=1

 

Paris Saint Joseph Hospital: The Medical Oncology Department Opens Access to Early Clinical Trials for Patients

The Saint-Joseph Hospital Oncology Department opens its first phase I clinical trial this summer. Opening access to therapeutic innovation in oncology is one of the priorities of the oncology department supported by the Group’s dynamic in terms of research. Bringing quality care, human approach and ethics with high technicality is the new challenge that the hospital group in cancerology wishes to meet.

Saint-Joseph Hospital offers multidisciplinary care to many cancer patients at all stages of their illness with the constant concern of responsiveness, quality of care, innovation, and ethics.

The dynamics of clinical research in oncology is now asserting the possibility for patients who wish to access early Phase I clinical trials for the first therapeutic applications of innovative drugs resulting from laboratory research. This new option complements an already important clinical research program in the hospital in connection with several academic and industrial groups.

The national and international expertise of prof. Eric Raymond, Chief of Medical Oncology and his assistants including Dr. Chantal Dreyer who recently joined the group at the clinical research center led by Dr. Hélène Beaussier are strong assets to attract new researches in this dynamic creates within the hospital group.

The medical oncology department in Saint-joseph hospital has been recently authorized by the High Authority for Health (HAS) for first-in-human clinical trials. This authorization was based on high quality-controlled procedures as well as the availability of material and human resources for the realization of these new innovative therapeutic trials (phase I and translational research). Several international and European academic research groups have already set up early trials on the hospital group, which will allow patients access to these innovations by remaining in their usual care facility.

This is undoubtedly the first experience of an early research center in a Parisian community health center, this activity being hitherto restricted to university and anti-cancer hospital centers. “The Clinical Research Center wishes to distinguish itself in combining innovation with traditional care, respect for people involved in research and ethics. We want to develop a human-centered research focused on the benefit of patients and not a dehumanized research or the sole purpose would be to do more activity ” says Professor Eric Raymond. “These values are shared by the hospital group on a day-to-day basis in patient care and the challenge is now to bring them access to innovation”, says Jean-Patrick Lajonchère, General Manager of the Paris Saint-Joseph Hospital Group.

 

Phase I trials are most often the first administration of a drug to humans. Phase I / II trials are a variation of Phase I trials, allowing a preliminary assessment of efficacy at the selected dose or testing of drug combinations. The interest of these phase I / II trials is to facilitate rapid access to innovative molecules, including so-called “biological” drugs. For more information consult the following links:

Les différentes phases des essais cliniques

Recherche clinique côté patients

Forum of innovative organizations of the GHPSJ

As every year, the CRC participates in the forum of innovative organizations of the establishment.
Three posters describe the new digital tools developed in 2017 and 2018 devoted to clinical research.
A fourth poster presents the internal circuit of phase I clinical trials since obtaining authorization for a biomedical research site from the french authorities.

        

Nuremberg conference

Posted the 16 February 2018

The Nuremberg Code is 70 – the eruption of modern medical ethics

RDV on Friday, February 16, 2018 for the Conference of Bruno Halioua, Physician, Historian, author of The Nuremberg Doctors Trial, (Érès, 2017)

Location: GHPSJ Meeting Room, Notre Dame de Bon Secours, Lv -1.
Schedule: from 13h to 14h.
“On August 19, 1947, Judge Walter Beals, who presided over the Nuremberg doctors’ trial for 139 days, established the criteria for defining “lawful medical experiments “. In this trial, which ended on August 21, 1947, the world discovered the scale and horror of the medical experiments that have been conducted on men, women and children in concentration camps. The ethical issues raised by the prosecution’s medical experts and their responses to the arguments of the accused and their lawyers formed the basis of the Nuremberg Code.
The drafting of the Nuremberg Code is an event of fundamental historical significance both legally and medically. It establishes for the first time the legitimacy of medical experiments, while setting limits to protect those who participate through the introduction of “informed consent”. It announces the birth of modern bioethics.

About the Author
Bruno Halioua is a dermatologist, lecturer in the history of medicine at the University Paris IV-Sorbonne.