Venatorx Pharmaceuticals is focused on conducting clinical studies and obtaining regulatory approval of investigational medicines in support of its mission to develop safe and effective treatments for infectious diseases. The best way for patients to get access to investigational medicines is by taking part in clinical trials. Please search ClinicalTrials.gov for publicly available information related to Venatorx’s ongoing clinical trials.
It is recognized that not all patients are eligible to enroll in clinical trials. Venatorx will consider requests so that patients with an immediately life-threatening condition or serious disease or condition who have exhausted other appropriate treatment options may, under the conditions described below and in accordance with applicable local law, have appropriate access to its investigational medicines in development before they are commercially available. Use of an investigational product outside the scope of a clinical study is often referred to as expanded access (sometimes called compassionate use).
Expanded access is allowed in some countries under local laws and regulations and must be conducted in compliance with applicable requirements. The requirements are different across countries and the type of use that is allowed (i.e., for individual patients or groups of patients) varies.
Venatorx will consider making available, for expanded access use for individual patients, an investigational medicine in response to an unsolicited written request from a licensed physician who is in a treatment relationship with the patient/s. Expanded access requests must be sent to firstname.lastname@example.org.
Venatorx considers the following factors when reviewing expanded access requests:
- The investigational medicine is being studied in humans under an appropriate regulatory authorization or all investigational studies of the product have been completed.
- The patient is suffering from a serious disease or condition, or whose life is immediately threatened by their disease or condition.
- Whether potential alternative treatment options are available or have been used previously with the patient.
- Patient ineligibility for participation in any ongoing clinical study of the investigational product.
- An assessment of the potential patient benefit justifies the potential risks of treatment.
- Available clinical information on the drug’s use.
- Meets any other relevant medical criteria for expanded access of the investigational product, as established by Venatorx.
- Providing the investigational medicine for expanded access or compassionate use will not interfere with development of the product.
- There are enough supplies of the investigational medicine to support the request as well as the ongoing and planned clinical trials.
- The physician attending to the patient/s for whom expanded access is sought agrees to comply with all applicable legal and regulatory requirements in relation to the request and any requirements in terms of medical criteria (e.g., clinical monitoring of the drug use), safety reporting or other data provision which Venatorx may require.
Certain expanded access and treatment studies, which involve the collection of safety and efficacy data, must be registered on ClinicalTrials.gov or other clinical trial listing website/s. The results of those studies must be made publicly available in accordance with the Venatorx standards on public disclosure.