Patient Enrollment

Functional Characteristics

of sNK Cells

NK101 is in the experimental stage and we have little data with respect to the treatment of patients suffering from cancer. Based on the four patients treated to date, no adverse safety events have been observed, but it is too early to assess the overall safety profile or whether NK101 will ultimately prove effective in the clinical treatment of solid tumors, particularly in the brain. A member of our clinical team can discuss the clinical results that have been observed with in patients that has received NK101 as you evaluate whether to proceed with this therapy as a palliative treatment option in Cancun.  

It is important to understand that NKore is not treating patients in Cancun, we are only referring patients to the Rehealth Clinic, (www.rehealth.com) a licensed treatment facility, for their evaluation to determine whether treatment with NK101 would be appropriate both clinically and in accordance with the palliative care requirements in Mexico.

NKore, as the owner of the product, has a contractual relationship with Rehealth for the manufacturing of the product in Cancun, and various administrative services, but Rehealth provides all clinical services. Accordingly, the $85,000 fee that Tracy mentioned would cover the following costs for Paddy’s initial infusion in Cancun: (1) the fees payable to the clinical team at the Rehealth Clinic in connection with the infusion of NK101, including the pre-treatment patient evaluation and the two post-infusion follow up visits that will be scheduled; (2) any applicable service fees or costs associated with the production or clinical use of NK101; (3) the fees payable to Dr. Jewett’s lab at UCLA in connection with the testing of Paddy’s immune cell function following this infusion; and (4) the transportation costs between the airport in Cancun, your hotel, and the Rehealth Clinic consistent with the treatment protocol. You will be required to incur other incidental costs associated with Paddy’s care in Cancun, including airfare to and from Mexico, hotel, meals, and any medical or transportation costs other than those payable to the Rehealth Clinic during your visit. If a positive clinical response is observed and Paddy elects to receive one or more subsequent infusions, those would be billed at $50,000 each and cover the same services.

Steps for Patient Enrollment

Step by Step: Patient Enrollment

• Our patient liaison will conduct a preliminary conversation with the patient and obtain the requisite HIPPA release forms;

• An initial review of the patient medical records will be conducted by a member of the Medical Advisory Board (MAB); 

• If the preliminary assessment is that the patient meets the inclusion/exclusion criteria, schedule a video call with the patient and the member of the MAB to discuss the therapy, the treatment protocol and other relevant information related to treatment;

• If the patient desires to move forward, provide access to the patient’s medical records to the clinical team in Cancun for their preliminary assessment with respect to the treatment of the patient;

• Engage the patient’s treating oncologist or a member of the patient’s clinical team to discuss the therapy and the prior clinical history;

• If the patient desires to move forward after consultation with his/her treating oncologist, convene a meeting of the MAB for presentation of the patient’s medical history in a format similar to a tumor review board and solicit a recommendation to proceed with the referral to Cancun;

• Assuming a favorable recommendation from the MAB, inform the patient and have Tracy coordinate the referral to the clinical team in Cancun, schedule the dates for treatment, obtain informed consents, coordinate the payment of fees, and assist in the logistics for treatment.