Tiziana Life Sciences LTD

“Tiziana Life Sciences is dedicated to developing new therapies that have a positive impact on patient health, and to serving patients, patient families and patient communities through education, empathy, and awareness. Consistent with Tiziana Life Sciences’ mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies. We believe this approach will serve patients who could be helped by the therapies we are developing. At the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. In these circumstances, Tiziana Life Sciences will consider providing a requesting physician with pre-approval access to a specific Tiziana Life Sciences investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following: - The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option; - The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition; - A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available; - Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and - Adequate supply of the investigational drug is available. We continually evaluate the benefit-risk profile of each of our investigational drugs based on evolving clinical data. Each compound under development is different and the fact that one investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different, or that a different investigational drug will be made available under our policy. Requests will be considered on a case-by-case basis. Tiziana Life Sciences is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; Tiziana Life Sciences may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by Tiziana Life Sciences, whose decisions are final. Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to ea@tizianalifesciences.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 5 business days after receipt.”

Qualitative improvements in PET imaging seen in 80% of non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access patients receiving intranasal foralumab for at least 6-months. FDA Allowance for an additional 20 Patients to be enrolled in the intranasal foralumab Multiple Sclerosis Expanded Access Program will allow further data collection and analysis.

Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed intranasal foralumab to be used under an Expanded Access (EA) IND in its first patient with moderate Alzheimer’s disease. Expanded access IND’s provide a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials.

At present, 10 patients with na-SPMS have been dosed in an open-label intermediate-size Expanded Access (EA) Program with an additional 20 patients recently allowed to enter the program by the FDA. All patients in this expanded access program have either improved or stabilized on treatment with foralumab.

Qualitative improvements in PET imaging seen in 80% of non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access patients receiving intranasal foralumab for at least 6-months. FDA Allowance for an additional 20 Patients to be enrolled in the Intranasal Foralumab Multiple Sclerosis Expanded Access Program.

Fully 70% of patients with nonactive secondary progressive multiple sclerosis (SPMS) who received foralumab nasal spray in an expanded access program (EAP) experienced a lessening in fatigue levels after six months of treatment. That’s according to early findings from the EAP — a program that enables patients with serious or life-threatening conditions to have access to an experimental therapy outside of clinical trials — as reported by Tiziana Life Sciences, foralumab’s developer. Meanwhile, the U.S. Food and Drug Administration has allowed the company to expand its EAP from 10 participants to a total of 30 — meaning that patients who are ineligible for the trial might be able to receive the medication in this compassionate use program. “Tiziana is glad to provide patients with [nonactive] SPMS who do not qualify to be enrolled on our Phase 2 trial … the possibility to receive open-label treatment with … foralumab. As there are no FDA approved treatments for [nonactive] SPMS, an EA program gives these patients access to this novel drug,” Cerrone said in that release.