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Lantheus (LNTH) Grants AHN Exclusive Rights for Use of Microbubbles in Combination with Ultrasound Assisted Gene Therapy for Development of Proposed Treatment for Xerostomia

April 30, 2021 8:33 AM

Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced a strategic collaboration with Allegheny Health Network (AHN), a western Pennsylvania healthcare delivery system headquartered in Pittsburgh, PA. Under the agreement, Lantheus’ microbubbles will be used in combination with AHN’s ultrasound-assisted non-viral gene transfer (UAGT) technology for the development of a proposed treatment for xerostomia.

Xerostomia, a lack of saliva production leading to dry mouth, has a variety of causes, including radiotherapy and chemotherapy, the chronic use of drugs and rheumatic and dysmetabolic diseases. It is also a common side effect of ionizing radiation used to treat head and neck cancer.1

A proof of concept Phase 1 clinical trial sponsored by a third party showed that Aquaporin-1 (AQP1), a trans-membrane protein that facilitates water movement across lipid layers, restored saliva flow in a human population using an adenovirus-based vector encoding AQP1 to a single previously irradiated parotid gland.2 The results from this study led AHN to research using UAGT technology targeting the salivary gland, which combines the use of nonviral DNA vector and lipid microbubbles with a low-frequency acoustic field to create a ‘sonoporation’ effect allowing gene transfer to the cells of the salivary gland without the introduction of viral antigens.3

According to Mark Trombetta, MD, Director of Clinical Program Development for the AHN Cancer Institute, a radiation oncologist and co-investigator in the network’s study of UAGT, thousands of cancer patients suffer from radiation-induced xerostomia, which can cause severe tooth decay, chronic oral pain, loss of taste, inability to eat properly and increased oral infections. Once xerostomia begins, it is a permanent condition.

“We believe that UAGT may provide long-term relief of radiation-induced xerostomia, with adjustable dosing and potential for booster doses over time,” said Warren Swegal, MD, an AHN head and neck surgeon and clinical lead of the network’s UAGT program. “No other existing treatment offers a long-lasting solution for this life-altering condition, and we are thrilled to be able to further develop and improve the therapy by leveraging Lantheus’ proven microbubble technology.”

“We are excited to support AHN in its efforts to progress this innovative development program. Xerostomia is a chronic and debilitating condition with limited treatment options for patients,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. “We believe our microbubble combined with AHN’s UAGT technology have the potential to make a difference in the lives of these patients.”

Lantheus will supply its microbubbles and activation devices to AHN. AHN will be solely responsible for all development work, future regulatory submissions and commercialization. The deal terms include a transfer price and royalties.

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