Expanded Access
STATEMENT OF OBI’S POSITION ON EXPANDED ACCESS (COMPASSIONATE USE)
OBI Pharma, Inc. (together with its wholly-owned subsidiary OBI Pharma USA, Inc., “OBI Pharma”) is a clinical stage biotechnology company committed to the development of safe and effective products for use in oncology areas of high unmet medical need. Our goal is to make available access to our unapproved products (investigational products) through participation in clinical trials and through expanded access programs. Expanded access programs allow for the use of investigational products outside a clinical trial when the primary purpose is to treat a serious, life-threatening condition.
In cases where a clinical trial is not an option, and the patient has exhausted all available treatment options, regulators/health authorities may grant permission for us to provide a treating physician with an investigational product pre-approval. Such individual use of an investigational product pre-approval is often called “expanded access” or “compassionate use” though other names may be used. OBI Pharma commonly refers to these requests as “expanded access”.
OBI Pharma is committed to making available our unapproved products (investigational products) through expanded access in cases where:
- the patient’s condition is severe or life-threatening,
- the patient has exhausted all other approved treatment options that the patient is able to tolerate, and
- the patient is ineligible to participate in existing clinical trials.
Access to an investigational product is possible when:
- the investigational product is actively being used in clinical trials and not approved for the indication in the jurisdiction concerned,
- there is sufficient clinical data available for the investigational product and the disease condition to anticipate that any potential benefit from treatment is likely to outweigh any potential risks to the patient,
- there is adequate data to permit selection of an appropriate dose level for the patient,
- there is sufficient product supply to support both the ongoing clinical trials and the expanded access request, and
- the expanded access request will not compromise the integrity of ongoing clinical trials or delay regulatory filings.
OBI Pharma may discontinue expanded‑access supply for an individual patient or program if (i) clinical data reveal an unfavorable risk–benefit profile, (ii) supply becomes unavailable, or (iii) regulatory authorities request suspension.
Our partnership with treating physicians:
The treating physician is solely responsible for overseeing patient treatment and safety. The physician is also solely responsible for obtaining Health Authority and Institutional Review Board approvals and patient consent prior to use.
Learn More:
If you are a physician who is interested in learning more about our investigational products, or participating in our clinical trials, please submit a request to expandedaccess@obipharma.com. We anticipate acknowledging receipt of requests sent to this email within five business days.
If you are a patient who is interested in accessing our investigational products, please speak with your physician. If you have additional questions, please contact expandedaccess@obipharma.com. You may also learn more about ongoing clinical trials by going to www.clinicaltrials.gov.
DISCLAIMER: An existing program does not guarantee availability in all jurisdictions. Various regulatory mechanisms exist in different jurisdictions to provide Early Access to new medicines and as a result, jurisdiction-specific variations for Early Access will occur. Any Early Access to medicines must always comply with the applicable jurisdiction-specific laws and regulations including investigational product importation requirements.