CORALVILLE, IA / October 3, 2022 / Viewpoint Molecular Targeting, Inc. (“Viewpoint” or the “Company”), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of [212Pb]VMT-α-NET for treatment of patients with SSTR2-positive unresectable or metastatic neuroendocrine tumors (NETs) (including GEP-NETs or bronchial NETs and pheochromocytomas and paragangliomas).
“Although several exciting new medicines have emerged in the past decade for patients with neuroendocrine tumors, there remains an unmet need for certain patient segments, where survival rates remain low” said Dr Frances Johnson, M.D., COO and co-founder of Viewpoint. Added Michael Schultz, Ph.D., CSO and co-founder of Viewpoint, “we applied for fast track designation based on the compelling results seen in head-to-head animal studies and are appreciative of the FDA being able to review the data expeditiously.” The Company expects the results of those studies to be presented publicly at the upcoming European Association of Nuclear Medicine (EANM) conference to be held October 15-19, 2022 in Barcelona, Spain.
“We are thrilled to receive FDA Fast Track Designation for our leading program,” said Thijs Spoor, CEO of Viewpoint. “This designation will allow us to actively explore the fastest ways to bring our personalized alpha-particle theranostics to patients.”
The FDA Fast Track Designation is one of several approaches utilized by the FDA to expedite development and review of potential medicines for serious conditions and that fulfill unmet medical needs. A potential new medicine may fill an unmet medical need by being the first therapy to address a specific serious condition, offer clinically significant advantages over available therapies, act via a different mechanism of action than available therapies, or have a benefit in patients who are unresponsive to or intolerant of available therapies. Programs that receive Fast Track Designation are entitled to more frequent interactions with the FDA on drug development plan, as well as eligibility for accelerated approval, priority review, and rolling review.
About Neuroendocrine Tumors (NET)
Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. According to cancer.net, it is estimated that more than 12,000 people in the United States are diagnosed with a NET each year. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors and as a result, there are approximately 175,000 people living with this diagnosis.
About Viewpoint Molecular Targeting
Viewpoint Molecular Targeting is a radiopharmaceutical company developing precision oncology therapeutics and complementary diagnostic imaging agents. The Company’s proprietary technology utilizes the isotope lead-212 to deliver powerful alpha radiation specifically to cancer cells via specialized targeting peptides. Viewpoint is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes. This “theranostic” approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments. The Company’s melanoma (VMT01) and neuroendocrine tumor (VMT- -NET) programs are entering Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at several leading academic institutions. The Company has also developed a proprietary lead-212 generator to secure isotope supply for clinical trial and commercial operations. For more information, please visit the Company’s website www.viewpointmt.com.
Viewpoint previously announced on September 29, 2022 that it has entered into a definitive agreement to merge with Isoray, Inc (NYSE AMERICAN:ISR), a medical technology company and innovator in seed brachytherapy. Additional details regarding the contemplated merger along with the merger agreement can be found in Isoray Inc.’s current report on Form 8-K which was filed with the Securities and Exchange Commission on September 28, 2022. The consummation of the merger is subject to approval by the shareholders of both Isoray and Viewpoint along with other customary closing conditions.
This press release contains information that includes or is based upon “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company’s expectations or forecasts regarding future events. These statements can be identified by the fact they do not relate strictly to historical or current facts. They may use words such as “believe,” “potential,” “estimate,” “expect,” “will,” and other terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, forward-looking statements include statements relating to intended future actions; the Company’s expectations about its addressable markets and market share; the consummation of the merger with Isoray and the realization of the anticipated benefits of the combination; the functionality and capabilities of the Company’s therapies; the potential size of the commercial market for the Company’s treatment programs; and the Company’s expectations beliefs, intentions or strategies regarding the future. Any or all of the Company’s forward-looking statements here and elsewhere may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements and from expected or historical results. Many such factors will be important in determining the Company’s actual future results. Consequently, no forward-looking statement can be guaranteed. The Company undertakes no obligation to correct or update any forward-looking statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law. These forward-looking statements (except as may be otherwise noted) speak only as of the date of this press release. Factors or events that could cause the Company’s actual results to differ may emerge from time to time, and it is not possible for the Company to predict all of them.
Investor / Media / Public Relations: Thijs Spoor (319) 665-2150
SOURCE: Viewpoint Molecular Targeting, Inc.
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