Varian Receives Investigational Device Exemption (IDE) and Prepares for First Ever Clinical Trial of FLASH Therapy

Rhea-AI Summary

Varian (NYSE: VAR) has received an Investigational Device Exemption (IDE) from the FDA for the FAST-01 clinical trial of FLASH therapy, an innovative radiation treatment that delivers ultra-high dose rates, potentially over 100 times faster than traditional methods. The trial aims to enroll 10 patients with bone metastases to evaluate the feasibility, side effects, and pain relief efficacy of this non-invasive approach. Varian's investment in research, including the collaboration with the FlashForward Consortium, underscores their commitment to advancing cancer treatment technologies.

Positive

• FDA approval of IDE for FLASH therapy indicates regulatory support and potential market advancement.
• Collaboration with the FlashForward Consortium enhances research credibility and development.
• Potential for FLASH therapy to significantly improve patient outcomes with reduced toxicity.

Negative

• None.

PALO ALTO, Calif., Oct. 12, 2020 /PRNewswire/ -- Varian (NYSE: VAR) today announced the company has received an Investigational Device Exemption (IDE) from the Food and Drug Administration (FDA) for the first-ever clinical trial of FLASH therapy, an experimental treatment modality delivering radiation therapy at ultra-high dose rates. FLASH therapy, involving ultra-high dose rates, and delivery in typically less than one second, may be over 100 times faster compared to conventional radiation therapy. The study, named FAST-01 (FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases), will involve the investigational use of Varian's ProBeam^® particle accelerator modified to offer this advanced non-invasive treatment option for patients with cancer. 

The concept of ultra-high dose rate radiation delivery has been studied for many years.  Dedicated research and development by Varian has led the advancement to the clinical study stage.  Varian's efforts include investing in bench and preclinical research and supporting the FlashForward^™ Consortium, a 20-member group of institutions from around the world, which includes experts in radiation oncology, translational sciences, and medical physics. 

"FLASH therapy could be one of the most significant advancements in cancer treatment in decades," said Kolleen Kennedy, Chief Growth Officer and President of Proton Therapy Solutions at Varian. "Our progress in advancing FLASH therapy on the ProBeam platform is a testament to Varian's investments in research that improve care for patients with cancer and the importance of our collaboration with clinicians around the world through the FlashForward Consortium."

The FAST-01 Feasibility Study, which is expected to enroll 10 patients with bone metastases, will evaluate clinical workflow feasibility, treatment-related side effects and efficacy of treatment as assessed by measuring trial participants' pain relief.

"Preclinical research of FLASH therapy indicates using ultra-high dose rates may be less toxic overall and enhance sparing of adjacent healthy tissue," added Deepak "Dee" Khuntia, M.D., Senior Vice President and Chief Medical Officer of Varian. "The study is an important proof of concept, especially in deep-seated and not just superficial tumors, that adds to a growing body of data necessary to advance our understanding of how FLASH therapy works."

Varian anticipates enrollment of the first patient in the FAST-01 Feasibility Study by the end of 2020.

About Varian
At Varian, we envision a world without fear of cancer. For more than 70 years, we have developed, built and delivered innovative cancer care technologies and solutions for our clinical partners around the globe to help them treat millions of patients each year. With an Intelligent Cancer Care approach, we are harnessing advanced technologies like artificial intelligence, machine learning and data analytics to enhance cancer treatment and expand access to care. Our 10,000 employees across 70 locations keep the patient and our clinical partners at the center of our thinking as we power new victories in cancer care. Because, for cancer patients everywhere, their fight is our fight. For more information, visit http://www.varian.com and follow @VarianMedSys on Twitter.

Press Contacts
Aimee Corso
Health+Commerce
+1 (310) 780-2661
aimee@healthandcommerce.com

Investor Relations Contact
Anshul Maheshwari
Vice President, Investor Relations
+1 (650) 424-5631
investors@varian.com

View original content:http://www.prnewswire.com/news-releases/varian-receives-investigational-device-exemption-ide-and-prepares-for-first-ever-clinical-trial-of-flash-therapy-301149339.html

SOURCE Varian

FAQ

What is the purpose of the FAST-01 study for Varian's FLASH therapy?

The FAST-01 study aims to evaluate the clinical workflow, treatment side effects, and pain relief efficacy for patients with bone metastases undergoing FLASH therapy.

When is Varian expected to enroll the first patient in the FAST-01 trial?

Varian anticipates enrolling the first patient by the end of 2020.

How does FLASH therapy differ from conventional radiation therapy?

FLASH therapy delivers radiation at ultra-high dose rates in less than one second, potentially over 100 times faster than conventional methods, improving treatment efficiency.

What are the expected benefits of using FLASH therapy according to Varian's research?

Preclinical research suggests FLASH therapy may be less toxic and better at sparing healthy tissue compared to traditional radiation methods.