Clinical Trial

Compassionate use or Pre-Approval Access to investigational medicines

At VasGene Therapeutics, our mission is wellbeing of patients and their families. We aim to bring medicines that represent transformational advances in the care of cancer patients.

Our team of scientists and clinicians are inspired by the success of their work and the potential of even greater achievements ahead.

We may receive inquiries about our medicine, beyond clinical trials, referred to as “compassionate use”.

Patients with serious illness who have already received standard of care but progressed and do not have any options are likely to seek new therapies.

We ask that the physician in charge of the patient ask for Pre-approval access to investigational drug. Each request will be reviewed by a physician to assure that the eligible patients can receive pre-approval investigational drug.

Decisions for Pre-Approval Access to the investigational medicine will be based on the safe use in the patient, given the investigational nature of these medicines that have not completed clinical trials for the specific disease and state. Next is the likelihood of benefit for the patient based on the clinical results of the investigational medicine. Discussion with the physician managing the patient will help determine if the investigational agent is the best option for the patient. Decisions for drug access will be made in a fair and equitable process. There is no guarantee that each request will be fulfilled.

We must also ensure that by providing the drug outside the clinical trial the completion of the trial, and thus drug development plan, regulatory review and approval is not adversely affected.

Request for Pre-Approval Access must be made by your physician who will request the drug from VasGene Therapeutics Inc. VasGene will respond to the request within 5 business days.

Below are the Eligibility Criteria for the request:

• The illness must be serious or life threatening.

• There are no other viable options (including approved products or active clinical trials).

• There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on what is known at present.

• There is a plan in place to make the medicine, once approved, available commercially.

• Whether or not sufficient quantities of the investigational medicine are available.

• Additional regarding the therapy, its development program, the patient, or other circumstances may impact eligibility.

Investigational drugs available

At VasGene Therapeutics, we are doing everything we can to ensure that patients with serious or life-threatening diseases receive the benefit of our innovative medicines as quickly as possible. We welcome requests for Pre-Approval Access (PAA) from the physicians treating these patients.

Submitting a Request Form
Request forms must be submitted by the healthcare professional. Patient eligibility will be determined by VasGene Therapeutics in accordance with established policies and procedures. VasGene Therapeutics’s acceptance and processing of this application does not guarantee that access to the investigational product will be provided.

DISCLAIMER

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

To the extent statements contained in the following presentation are not descriptions of historical facts regarding the company, they should be considered “forward-looking statements,” as described in the private securities litigation reform act of 1995, that reflect management’s current beliefs and expectations. You can identify forward-looking statements by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “hope,” “hypothesis,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “strategy,” “will,” “would,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. Forward-looking statements contained in these presentations include, but are not limited to, statements regarding: (i) the success and timing of our product development activities and clinical trials; (ii) our ability to develop our product candidates; (iii) our plans to research, discover, evaluate and develop additional potential product, technology and business candidates and opportunities; (iv) our ability to develop and manufacture our product candidates and to improve the manufacturing process; (v) our ability to attract and retain key scientific or management personnel; (vi) the anticipated timing of clinical data availability; (vii) our ability to meet our milestones; (viii) our expectations regarding our ability to obtain and maintain intellectual property protection; and (ix) the impact of capital market conditions on us. Forward-looking statements are subject to known and unknown factors, risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such forward looking statements. Undue reliance should not be placed on forward-looking statements. We undertake no obligation to publicly update any forward-looking statements. The company’s investigational drug products have not been approved or cleared by the FDA.

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