LISCure Biosciences는 미충족 의료 수요가 높은 질병에 대한 마이크로바이옴 기반 신약 개발에 주력하는 임상 단계 제약사입니다.
- 2024.04.03
- 관리자
Expanded Access Policy:
LISCure
Biosciences is a clinical-stage pharmaceutical company focusing on the
development of microbiome-based novel drugs
against diseases with high unmet medical needs.
There may be patients facing serious or
life-threatening diseases who may not qualify for an ongoing clinical trial,
but who may benefit from an investigational drug. For these patients, the
patient’s physician may choose to request access to an investigational drug
outside of a clinical trial through an expanded access program.
The following criteria and applicable
regulations should be taken into account:
· Patient has a serious or
immediately life-threatening disease or condition.
· There is no comparable
or satisfactory alternative therapy to diagnose, monitor, or treat the disease
or condition.
· Patient enrollment in a
clinical trial is not possible.
· There are sufficient
clinical data available from its existing clinical trials to
anticipate that the
potential benefits justify the
potential risks to the patient
· Providing the
investigational drug will
not interfere with clinical
trials that could support a investigational product’s development
or marketing approval for the treatment indication.
At this time, LISCure Biosciences does
not open expanded access program as we are
in early stage of development. We believe that participating
in our clinical trials is the most appropriate way to access our
investigational drugs because the clinical trials are the
most effective way of generating safety and efficacy data for review and
decision making by regulatory authorities. When more clinical data is
available, LISCure Biosciences continues to evaluate it and assess the criteria
for expanded access program and will update this policy from time to time.
If you are a patient or healthcare provider interested in
learning more about our investigational drugs and participating in our clinical
trials, please contact us at: clinical@liscure.bio . LISCure will
acknowledge receipt of your inquiries within 5 business days of receipt.