Expanded Access Policy
Purpose and philosophy behind the policy
LaNova Medicines is a science-driven biotechnology company focusing on the research and development of innovative antibody drugs for cancer. We are encouraging patients to participate clinical trial for novel therapy, which is the most important and effective way to get access to investigational medicines, however, the investigational medicines might or might not be effective for a particular subject even pre-clinical or preliminary clinical data has shown some promising signal. You can find our clinical stage pipeline from Pipeline-LaNova Medicines including LM-108, our leading molecule CCR8 targeting antibody.
Approach to requests for access to experimental therapies
Participation in clinical trials is the first and most preferable route. Clinical trials are human research studies designed to evaluate whether an investigational medicine is safe and effective for patients. People who choose to participate in clinical trials play a vital role in developing new medicines, which may support approval by regulatory health authorities and make these medicines more broadly available to patients who may need them. To learn more about our ongoing clinical trials, including your potential eligibility to participate, consult with your doctor or visit https://clinicaltrials.gov/ to get the latest information for ongoing clinical trials.
We understand the interest of patients in accessing LM-108 and other novel investigational medicines outside of clinical trials and prior to regulatory approval for potential life-threatening diseases, however we do not currently offer Expanded Access Programs for our investigational medicines as all of them are still in early phase clinical stage.
In very rare and specific circumstances, patients with serious or life-threatening disease may still need access to our investigational medicines. Please consult with your physician, the requests will be reviewed with our physician case by case. Several important medical and logistic criteria need to be met including: The disease is serious or life-threatening; All other available alternative therapies have been exhausted, but the patient may still benefit from further treatment with an investigational medicines; A clinical trial is not available, either because patients are ineligible or because they have no access to the trial; The efficacy and safety data available at the time are of sufficient strength to determine whether the benefit to the patient would likely outweigh the potential risks; and Access is compliant with all applicable laws and regulations. There is an adequate supply of the investigational medicine in local. There is an ongoing clinical trial in local which can support the investigational medicines distribution. Regulatory requirements have been completed based on local IRB requirements, such as compassionate use.
Process for Requesting Access
If you are not eligible for a clinical trial or no appropriate clinical trial exists, and your qualified treating physician believes that an investigational medicine available may be the best and the only treatment option for you, your physician should contact us on your behalf by emailing LM-108EA@lanovamed.com. Our physician will acknowledge the requests within 5 business days of receipt.
The company may request additional information, including patient history, in order to fully evaluate the request.