Physicians and Patients

Physicians and Other Healthcare Professionals

For information on the NanOlogy investigational drugs or clinical trial programs, please contact NanOlogy at 817-900-4002 or send an email to nanology@dfb.com.

Below is a list of organizations that provide helpful information for patients, caregivers, and healthcare providers.

Expanded Access Policy

Expanded Access, sometimes called “compassionate use,” is defined by FDA as the use outside of a clinical trial of an investigational medical product. It was established to allow patients with serious or life-threatening conditions, who do not meet the enrollment criteria of clinical trials in progress, potential access to investigational medical products.

NanOlogy is highly focused on successfully advancing our investigational drugs through the regulatory process as we know this will provide access of our drugs to the most patients in the shortest timeframe. In addition, the safety and efficacy of local delivery of our investigational drugs, as well as optimal techniques for local delivery, have not been fully established. As such, NanOlogy does not routinely offer Expanded Access to our investigational drugs but rather encourages patients to speak with their physicians about eligibility to enroll in any of the NanOlogy clinical trials that may positively impact the patient’s illness.

On an exceptional basis, however, NanOlogy may consider requests from US-licensed physicians for their patients who have exhausted all viable alternative therapies. Requests for Expanded Access must come from the treating physician via email to: nanology@dfb.com. NanOlogy will seek to respond to such requests within 10 business days.

Factors that NanOlogy Will Consider:
  • The clinical situation of the patient for whom the treating physician seeks access, including whether all approved therapy or clinical trial options have been exhausted
  • Whether the treating physician believes that the potential benefits of our investigational drug will outweigh any potential risks to the patient
  • The ability of the treating physician to adequately communicate to the patient the potential risks and benefits of the proposed use of our investigational drug so that the patient can provide informed consent and the willingness of all parties to sign a release for such use
  • The ability of the treating physician to deliver our investigational drug locally utilizing techniques such as ultrasound guided injection that are being established in our clinical trials
  • The likelihood that regulatory authorities and institutional review boards (IRB’s) will review and approve expanded access for the patient in a timely fashion
  • The commitment of the treating physician to obtain IRB approval and maintain an investigational new drug (IND) application
  • The impact of providing access to an investigational drug on the development program for that drug, resource limitations, and available supply of the investigational drug
  • Other factors NanOlogy may deem appropriate in our sole discretion

NanOlogy reserves the right to revise or discontinue this policy without notice.

(817) 900-4002
3909 Hulen Street
Fort Worth, Texas 76107