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Oraya IRay Update 2: INTREPID Two-year Results Meet Primary Clinical Endpoint – Results in At Least 35% Fewer anti-VEGF In

Posted Mar 05 2013 3:51pm

The last time we checked in on Oraya in May 2011, the company had announced it had completed enrollment in its INTREPID clinical trial, being conducted at seven European sites with the enrollment of a minimum of 150 patients. ( Oraya IRay Update: Company Completes Enrollment in European Clinical Trial )

The INTREPID trial is the first sham-controlled double-masked study to evaluate the effectiveness and safety of a one-time radiation therapy in conjunction with as-needed anti-VEGF injections for the treatment of wet AMD. A total of 21 sites in five European countries participated in the trial with a total enrollment of 230 subjects.

During the EURORETINA Congress, held in Milan, Italy, at the end of September 2012, Timothy L. Jackson, PhD, FRCOphth, King’s College Hospital, London, lead investigator for the trial, presented the results during the program’s AMD session. He reported that the trial achieved its primary end point demonstrating a statistically significant reduction in as-needed injections after one year. The actively treated patients required approximately 35 percent fewer injections than the sham group with similar or in some cases, better visual acuity outcomes. No radiation-related adverse events were experienced at the one year end point; including 60 subjects already at two year follow up. In addition, a defined population sub-group comprised of roughly half of the study participants experienced even lower injection rates while exhibiting meaningful vision benefit compared to sham.
Jackson stated that, “The year one results of the INTREPID trial are very encouraging for people with wet AMD—the prospect of fewer eye injections will appeal to all those receiving anti-VEGF therapy, and for certain subsets there is the added advantage of an improved visual outcome. Whilst it will be important to monitor safety over a longer period, the results so far suggest a favorable safety profile.”
Jim Taylor, CEO of Oraya Therapeutics, added, “We are very pleased that the results of the  INTREPID trial have validated the benefits of the Oraya Therapy for patients, clinicians and health  care providers. It is rare to have a new therapy that demonstrates improved patient outcomes while simultaneously offering the potential to significantly reduce treatment burden and costs. To have these benefits validated in a rigorous clinical trial is very rewarding, and we are exceptionally grateful to the patients and clinicians who participated in this important study.”
Then, the following month, at the British and Eire Association of Vitreoretinal Surgeons (BEAVRS) meeting in Dublin, Dr. Jackson presented a further analysis of the INTREPID results, discussing an analysis of the best responders in the INTREPID trial showing that anti-VEGF injections were reduced by 54% in the patient sub-group characterized by the presence of significant fluid and smaller lesion size.
Dr Jackson said: “A post-hoc analysis looked for the best responders to stereotactic radiotherapy and found that they had significant fluid at baseline and a lesion size of 4 mm or less in greatest linear dimension.”
“This dimension corresponds to the diameter of the spot beam (90% isodose) projected onto the retina by the IRay device. The 26% of patients with both of these characteristics not only had a reduction of 54% in the number of PRN injections but also a mean vision superiority of 6.8 ETDRS letters compared to equivalent patients in the control group.”
Dr Jackson added: “The one-year results of the INTREPID study are encouraging for clinicians and for individuals with neovascular AMD. The prospect of needing fewer eye injections will appeal to any patient receiving anti-VEGF therapy, and for certain sub-sets there is the added advantage of an improved visual outcome. The study showed a favorable safety profile for the procedure, and safety review is ongoing to detect any later effects of the radiotherapy treatment.”
Oraya Therapeutics Joins Forces with Optegra Eye Hospital Group
In December 2012, Oraya Therapeutics, Inc. announced that an agreement had been reached with UK specialist eye hospital group Optegra, to establish Optegra as the world’s first clinical centers to offer Oraya Therapy Stereotactic Radiotherapy for the treatment of wet Age-related Macular Degeneration (AMD).
The agreement was reached shortly after Oraya released data from a successfully completed clinical trial (The INTREPID Study) involving 21 sites and conducted in the UK and four other European countries.
Ophthalmic surgeon at Optegra, Andy Luff, commented: “Wet AMD currently affects approximately 260,000 people in the UK2, and it is projected that nearly 40,000 new people will be affected each year. The chronic injection therapies currently in use often require six to eight injections per year placing an unsustainable and costly burden on the National Health Service (NHS), on patients and on their families.”
Gareth Steer, Managing Director for Optegra, said: “Optegra is excited to have been selected to offer the Oraya Therapy as a treatment option that can help to mitigate this critical problem. We are pleased to have the opportunity to work with the innovative and dedicated people of Oraya, and to have the benefit of a scientifically sound clinical trial to support the value and potential of this unique therapy.”
In commenting on the choice of Optegra and the UK for the global introduction of the therapy, Jim Taylor, CEO of Oraya Therapeutics, said: “We are exceptionally proud and pleased to have partnered with Optegra, an organization that shares our values regarding the importance of good science, a focus on services that offer better patient outcomes and greater cost effectiveness, and with a commitment to the highest standards of quality and patient care. Bringing the therapy to the UK also provides us the opportunity to address a recognized and urgent need within the NHS for better therapeutic solutions, and we look forward to working with Optegra and the NHS to expand the access and availability of this important therapy in the months ahead.”
Finally, at the end of February 2013, the company announced that one of the patients who successfully was treated for wet age-related macular degeneration (AMD) with Oraya Therapy during the INTREPID clinical trial has released data showing he has experienced significant, sustained vision improvement more than two years after treatment in his right eye, without any subsequent anti-vascular endothelial growth factor (anti-VEGF) injections or other treatment. The patient, well-known British author Jonathan Gathorne-Hardy, also said he had experienced significantly reduced central vision in his left eye following standard anti-VEGF treatments over the same time period.
Oraya president and CEO Jim Taylor commented, “These life-changing results for patients with wet AMD further underline the efficacy of Oraya Therapy, and are the real source of motivation behind all that we do. With the ability to improve the vision of wet AMD patients with fewer injections – and in this case no injections at all – Oraya Therapy can offer a more convenient, effective and cost-effective treatment for this debilitating disease.”
Mr. Gathorne-Hardy was one of 230 patients enrolled in the multi-national INTREPID study evaluating the 20-minute, non-invasive therapy. He has wet AMD in both eyes, and received he Oraya Therapy at King’s College Hospital, London on his right eye in August 2010. After one year, the visual acuity in his right eye was significantly improved, with a vision gain of nine letters on his visual acuity score, and after two years has stabilized at an acuity better than before the Oraya Therapy. He has not received any subsequent anti-VEGF injections into the eye or any other treatment. In contrast, the central vision of Mr. Gathorne-Hardy’s left eye, diagnosed in 2008 and treated solely with the standard anti-VEGF injections, was significantly reduced.
All patients in the INTREPID trial previously had received at least three anti-VEGF injections in the prior year and required further anti-VEGF treatment. Within two weeks of receiving the injection, one-third of the subjects received a sham exposure and the remainder received a radiation dose of either 16 or 24 Gray (Gy). They were then followed monthly and treated with anti-VEGF (Lucentis) as needed according to specified reinjection criteria.
Results of the trial showed that further injections were reduced by 32 percent in the radiotherapy groups compared with the control group. These radiotherapy groups were twice as likely to receive no injection over the course of a year and were approximately half as likely to need four or more injections over the course of a year. Also, post-hoc analysis looked at the best responders to stereotactic radiotherapy and identified a group of patients which experienced a 54 percent reduction in the number of injections and a mean visual superiority of 6.8 ETDRS letters compared to equivalent patients in the control group.
“The results of the INTREPID study which have been reported to date are encouraging for clinicians and for individuals with wet AMD. The prospect of maintaining vision while needing fewer eye injections will appeal to any patient receiving anti-VEGF therapy, and for certain subsets in the trial there is the added advantage of an improved visual outcome,” said Timothy L. Jackson, PhD, FRCOphth, King’s College Hospital, London, lead investigator for the trial.
The Oraya Therapy is now available at the Optegra Surrey Eye Hospital in Guildford, United  Kingdom, establishing Optegra as the world’s first clinical centre to offer Oraya Therapy.
Tim Clover, CEO of Optegra, said: “Optegra treats many patients with AMD and knows the frustration of managing this disease. We are committed to encouraging new therapies that ill have a positive impact on patients. Oraya Therapy offers a real benefit to patients and Optegra is proud and excited to be selected as Oraya’s launch partner. We are pleased to have the opportunity to work with the innovative and dedicated people of Oraya, and to have the benefit of a scientifically sound clinical trial to support the value and potential of this unique therapy.”
Status of U.S. Clinical Trials:
When asked about progress towards U.S. clinical trials, Jim Taylor, CEO of Oraya responded with this, “On the topic of (the) U.S., the results from the INTREPID trial provide us a clear understanding of the trial design most appropriate and suitable for the FDA process; and with a high probability of success. The company is currently raising the capital needed to support the initial commercialization efforts in Europe, and that funding might also support the implementation of the US trial. Decisions on when to initiate the US trial will be based on the availability of that financing.”

For a full report on the Oraya IRay system and how it works, see my first writeup from November 2009: Oraya IRay In-office Stereotactic X-ray Treatment for AMD: A First Report


Reference Links: 
Company News ReleasesSept 20, 2012
http://www.orayainc.com/wp-content/uploads/2012/09/Oraya-EURETINA-release-FINAL.pdf

November 22, 2012
http://www.orayainc.com/wp-content/uploads/2012/11/ORAYA-_BEAVRS_PR_22Nov2012_FINAL.pdf  
Dec. 11, 2012
http://www.orayainc.com/wp-content/uploads/2012/02/OrayaOptegraReleaseFINALGlobal.pdf
Feb 27, 2013
http://www.orayainc.com/wp-content/uploads/2013/03/Intrepid_Results_FINAL_022713.pdf


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