Expanded Access Policy
At SonALAsense, our mission is to develop sonodynamic therapy (SDT) as a new modality to defeat cancer and create cancer survivors. We understand the urgent and extreme circumstances patients and their families face. SonALAsense is a new small company with limited financial resources.
1. Clinical Trials
SonALAsense is committed to helping those affected by DIPG and rGBM and is actively conducting clinical trials to determine the safety and benefit of SDT, which uses SONALA-001 (our drug) and an MR-guided focused ultrasound device. It is critical that those affected by DIPG and rGBM are evaluated per the clinical study protocols and that we take the appropriate safety measures with patients who are at the heart of our cause and efforts.
Participating in a clinical trial is the most appropriate way to access our investigational therapies. SonALAsense is required to evaluate its drug in clinical trials to determine safety and effectiveness. To participate in a SonALAsense study, individuals must meet certain inclusion and exclusion criteria. Please click on the links below to see ongoing SonALAsense studies:
Diffuse Intrinsic Pontine Glioma (DIPG) Clinical Study (SDT-201): https://clinicaltrials.gov/ct2/show/NCT05123534
Recurrent Glioblastoma (rGBM) Clinical Study (SDT-202): https://clinicaltrials.gov/ct2/show/NCT05370508
2. Expanded Access for SONALA-001
Wherever possible, use of an investigational medicinal product by a person affected by cancer as part of a clinical trial is preferable because clinical trials generate data regarding the efficacy and safety of the investigational medicinal product. Those data help inform whether the benefits of the investigational medicinal products outweigh the risks, whether it should be approved by the regulatory authorities leading to wider availability and, if approved, when and how it should be used.
As it relates to individuals, single patient expanded access, sometimes called “compassionate use”, is the use by an individual patient of an investigational medicinal product outside of a clinical trial that is intended to treat a serious or life-threatening condition.
In very specific cases, we may be able to provide access to our investigational drug outside of our clinical trials if certain conditions are met. Single Patient Expanded Access may not always be available as each patient is unique and this will be at the discretion of a physician based on many factors and conditions. To be eligible for access to the investigational medicine, a physician must apply and certify that the patient for whom the application is being submitted meets the following criteria:
Diagnosed with a serious, life-threatening or severely debilitating disease;
Unable to participate in SonALAsense clinical trials;
Have no comparable or satisfactory alternative treatment option available;
The risk/benefit profile of the investigational drug is favorable in light of the sufficient safety and efficacy information and the treating physician’s assessment of the patient’s medical condition.
Physicians may contact SonALAsense for further information at email@example.com. It is important to remember that SONALA-001 is an investigational medicine and the MR-guided focused ultrasound device used in the SonALAsense clinical trials is an investigational device. Neither have received regulatory approval; thus, their potential risks and benefits are not yet established. Physicians and patients should consider all possible benefits and risks when seeking access to an investigational medicinal product.
SonALAsense may revise this policy at any time and changes will be posted on this website.