Targeted Alpha-Particle Radiotherapy for Cancer
Expanded Access Policy
Our new, proprietary class of theranostics enable the ability to see a specific tumor and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments.
Important information about our Theranostic technology…
We Are Developing a New Class of “Theranostics” to Treat Cancer
Targeted Theranostics Provide the Potential to Improve Efficacy and Minimize Toxicity
Through the use of proprietary, specialized targeting peptides, we are able to diagnose and then deliver our powerful alpha-particle radiotherapy directly to the tumor. Utilizing a radioactive imaging agent, Pb-203, connected to a specific targeting peptide, we have the ability to diagnose the tumor. Following diagnosis, we link our alpha-particle radioactive isotope, Pb-212, to the same targeting peptide to treat and potentially kill the tumor. This two-step, personalized medicine approach offers the ability to understand which patients may respond to our therapy and potentially improve efficacy while minimizing toxicity associated with many other types of cancer treatments.
Access to Investigational Medicines
- To serve patients, Viewpoint engages in clinical research with the goal of obtaining regulatory approval of its products.
- Clinical trials allow Viewpoint to evaluate investigational new treatments in volunteers in order to generate the safety and efficacy information needed to obtain approval of those treatments and make them available to the broader patient population. More information about Viewpoint clinical trials of its investigational products can be found at clinicaltrials.gov.
- Outside of a clinical trial, Viewpoint may provide access to its investigational products as permitted by applicable law and only in the following situations:
- Viewpoint may provide expanded access (sometimes referred to as “compassionate use”) to its investigational products to patients with a serious or immediately life-threatening disease when no comparable or satisfactory alternative therapy options are available in response to a written request from a licensed treating physician and when all of the criteria discussed below are met.
Criteria Used for Considering Requests for Expanded Access
- Viewpoint will evaluate and respond to each expanded access request that it receives on a case-by-case basis based on the following criteria:
- The patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative therapy for the disease or condition.
- There is a compelling medical and scientific rationale for the requested use. Specifically, sufficient clinical evidence of safety and effectiveness in the indication has been established, the potential benefit justifies the potential risks, and the potential risks are not unreasonable within the context of the disease or condition.
- The treating physician and their institution have adequate training, facilities, equipment, and personnel to administer the investigational product.
- The investigational product is under active development in the indication and expanded access will not interfere with the development of the product, including any ongoing or planned clinical trials.
- Viewpoint has adequate supply of investigational product.
- There is a legal and regulatory framework in the country or region that permits and supports expanded access/compassionate use of investigational products, and Viewpoint has the resources and abilities to provide investigational product to such country or region.
Process for Requesting Expanded Access
- Patients interested in seeking expanded access to a Viewpoint investigational product should talk to their physician. To submit an expanded access request or request information about applying for access to one of Viewpoint’s investigational products, treating physicians should contact Viewpoint by phone at 319-665-2150 or by email at ExpandedAccess@viewpointmt.com
- Viewpoint typically will acknowledge receipt of a request for expanded access within three business days.
- Viewpoint experts will carefully review all expanded access requests in consideration of the above criteria.
- All physicians who receive Viewpoint investigational product through expanded access are required to comply with all applicable laws and regulations, and contractual conditions, including those relating to safety and outcomes reporting.
- Additional information regarding Viewpoint’s clinical studies and ongoing expanded access uses of its products can be found on ClinicalTrials.gov using the following hyperlink(s) and ClinicalTrials.gov Identifier(s):
- As authorized by the 21st Century Cures Act, Viewpoint may revise this expanded access policy at any time. Additionally, the posting of this policy by Viewpoint shall not serve as a guarantee of access to any specific investigational drug by any individual patient.