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Single-Patient EA Policies/Criteria

https://laminarpharma.com/lipid-research_/#clini

Single-Patient EA Policies/Criteria

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.

Available Therapies via Single-Patient EA

Expanded Access

• 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.
   

Single-Patient EA Policies/Criteria

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.

Available Therapies via Single-Patient EA

Expanded Access

• 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.
   

Single-Patient EA Policies/Criteria

Policy Statements
Any use of the Lantern Pharma investigational product LP-184 outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including Lantern Pharma policies and procedures.
In general, where permitted by local regulation, the investigational product LP-184 supplied via Expanded Access may no longer be provided by Lantern Pharma when it becomes available via the local healthcare system.
Lantern Pharma may decide not to provide LP-184 under this policy if the Company does not intend to market the product in the country.
Expanded access requests will be considered on a case-by-case basis in a fair and equitable manner.

A. Patient Eligibility Criteria

To be eligible for access to the investigational product LP-184, patients must meet the following criteria:
• Suffer from a serious or immediately life-threatening histopathologically confirmed recurrent IDH wild type supratentorial GBM.
• Have undergone appropriate standard treatments without success and no alternative treatment is available or exists to treat the disease or condition.
• Are ineligible for participation in any ongoing clinical study of LP-184, which includes lack of access due to geographic limitations.
• The patient’s condition is such that there is evidence of a projected benefit from the use of LP-184 and the benefit outweighs the known or anticipated risks.
• There is adequate information to support appropriate dosing for a special population of patients such as pediatric, elderly, renal or hepatic disease, etc.
• Any other pertinent medical criteria for access to LP-184, as established by Lantern Pharma’s clinically or medically responsible individual.

B. Investigational Product Criteria

In addition to the patient eligibility requirements, the investigational product LP-184 must meet the following criteria:
• LP-184 is under investigation in one or more clinical studies.
• There is sufficient evidence to expect that LP-184 will have an acceptable safety profile for the intended patient population.
• The provision of LP-184 will not interfere with or compromise the clinical development of the product.
• There is adequate supply of the investigational product to support expanded access.

C. Treating Physician Criteria and Responsibilities

The physician(s) attending to the patient(s) who is/are receiving the investigational product LP-184 through compassionate use access is (are) properly licensed and fully qualified to administer the product. The physician must agree in writing to comply with:
• Any applicable country-specific legal and regulatory requirements related to providing an investigational product under Expanded Access.
• Any Lantern Pharma requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property.

Available Therapies via Single-Patient EA

LP-184

Disease/Category-Specific EA Policies/Criteria

https://www.leaptx.com/for-patients

Single-Patient EA Policies/Criteria

LMI is not offering expanded access to PI-2620 or other products at this time.

Single-Patient EA Policies/Criteria

Expanded Access Program Policy for LNS8801
LNS8801 is currently being developed for the treatment of advanced cancer and has fast track designation for the treatment of patients with metastatic or unresectable melanoma who have progressed on or after anti–programmed cell death receptor or ligand (anti–PD-1/L1) therapy. Linnaeus Therapeutics (Linnaeus) understands that advanced cancer patients with limited therapeutic options may desire to try promising experimental therapies such as LNS8801. 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 Linnaeus’s ongoing clinical trials.

It is recognized that not all patients are eligible to enroll in clinical trials. Linnaeus may consider requests for expanded access (sometimes called compassionate use) at this time due to limited drug supply.

Linnaeus hopes that in the near future it will be able to regularly consider requests so that patients in the United States 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.

For more information regarding Linnaeus’ current and future expanded access policies please contact, medinfo@linnaeustx.com. Linnaeus anticipated being able to response to inquiries within one week.

Available Therapies via Single-Patient EA

LNS8801 - advanced cancers

Single-Patient EA Policies/Criteria

SCOPE
This policy applies to provision of access to Lion TCR’s investigational product(s) that is not approved for any purpose in the country from which the request is intended to be used. This also includes the time period between regulatory approval of an investigational product and its commercial availability in a country.

POLICY STATEMENTS
Any use of Lion TCR’s investigational product(s) outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including our policies and procedures.
In general, where permitted by local regulation, the investigational product supplied via Expanded Access may no longer be provided by Lion TCR when it becomes available via the local healthcare system.
Lion TCR may decide not to provide an investigational product under this policy if the Company does not intend to market the product in the country.

A treating physician, who is able to comply with the requirements that are stated in this document, may request information about how to apply for access to Lion TCR's investigational products by contacting the Company at clinicaltrials@liontcr.com . We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 5 business days after receipt.
Lion TCR is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; Lion TCR may require more detailed information in order to fully evaluate a request. Requests will be considered on a case-by-case basis.

Lion TCR will consider providing a requesting physician with pre-approval access to a specific investigational drug outside of a clinical trial, when the following conditions are met:

A. Patient Eligibility Criteria
To be eligible for access to an investigational product, patients must meet the following criteria:

• Suffer from a serious or immediately life-threatening disease or condition.
• Have undergone appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.
• Are ineligible for participation in any ongoing clinical study of the investigational product, which includes lack of access due to geographic limitations.
• The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational product and the benefit outweighs the known or anticipated risks.
• Any other pertinent medical criteria for access to the investigational product, as established by the Lion TCR clinically or medically responsible individual.

B. Investigational Product Criteria
In addition to the patient eligibility requirements, the investigational product must meet the following criteria:

• The product is under investigation in one or more clinical studies.
• There is sufficient evidence to expect that the investigational product will have an acceptable safety profile for the intended patient population.
• The provision of the investigational product will not interfere with or compromise the clinical development of the product.

 
C. Treating Physician Criteria and Responsibilities
The physician(s) attending to the patient(s) who is/are receiving an investigational product through compassionate use access is (are) properly licensed and fully qualified to administer the product. The physician must agree in writing to comply with:

• Any applicable country-specific legal and regulatory requirements related to providing an investigational product under Expanded Access.
• Any requirements from Lion TCR in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property.

Available Therapies via Single-Patient EA

LioCyx-M for hepatocellular carcinoma

Disease/Category-Specific EA Policies/Criteria

https://drive.google.com/file/d/1d9bjsBW4w7WpsBFcXEZT8fwd8OvB8GAx/view

Available Therapies via Single-Patient EA

Currently, Lisata does not make its unapproved drugs available on an expanded access basis. Lisata does, however, encourage interested individuals to contact the Company regarding potential participation in its clinical trials.

Single-Patient EA Policies/Criteria

At Lumicell, our focus is on the development of pegulicianine. The goal of our current clinical study program is to enroll patients and obtain clinical data on pegulicianine that is required by the US Food and Drug Administration (FDA) and other regulatory authorities for review and approval of marketing applications for this investigational agent. We believe that focusing on clinical studies is the most appropriate way to achieve this goal; therefore, we do not currently offer access to pegulicianine outside of clinical studies and, at this time, we have no Expanded Access program (sometimes referred to as “compassionate use” or “pre-approval access”).
For information on participating in and status of pegulicianine clinical trials, please see: https://clinicaltrials.gov/ct2/home
If you have additional questions regarding this policy, please speak with your health care provider or contact: info@lumicell.com