On May 25, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported to share news of the publication of a study from researchers at Winship Cancer Institute of Emory University (Winship) evaluating Axumin (fluciclovine F 18) PET imaging in men with recurrent prostate cancer (Press release, Blue Earth Diagnostics, MAY 25, 2021, View Source [SID1234580533]). The randomized, prospective study showed that Axumin-guided post-prostatectomy radiation therapy increased biochemical event-free survival rates in men with recurrent disease. Among 165 patients whose prostate cancer had returned following surgical removal of their prostate, 75.5% whose treatment integrated Axumin PET imaging were event-free after three years, compared to 63% for whom only conventional imaging techniques were used to plan treatment. The increased event-free survival rate persisted after four years of follow-up, at 75.5% vs. 51.2%, respectively. Provider-reported genitourinary or gastrointestinal side effects were similar between the two study groups. Axumin, a novel amino acid-based radiopharmaceutical, is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

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The manuscript, "EMPIRE-1: Randomized Trial Comparing Conventional- vs Conventional plus Fluciclovine (18F) PET/CT Imaging-Guided Post-Prostatectomy Radiotherapy for Prostate Cancer," was published online in The Lancet on May 7, 2021 (DOI: View Source(21)00581-X). The manuscript will also appear in an upcoming print issue. The EMPIRE-1 (Emory Molecular Prostate Imaging for Radiotherapy Enhancement) trial (NCT01666808) is the first randomized trial of men with recurrent prostate cancer to show that treatment based on advanced molecular imaging with 18F-fluciclovine PET can improve event-free survival rates. The Phase 2/3 trial was led by Winship radiation oncologist and prostate cancer specialist, Ashesh B. Jani, MD, MSEE, FASTRO, and Winship nuclear medicine specialist David M. Schuster, MD, FACR.

"We are extremely pleased that these exciting results, from Emory University’s independent study of how PET imaging with Axumin can influence radiation therapy treatment outcomes, have been made available to the physician community through publication in the well-respected medical journal, The Lancet," said David Gauden, D. Phil., President of R&D and CSO of Blue Earth Diagnostics. "We sincerely congratulate the researchers on the design and execution of this important study. Axumin was invented at Emory to enable PET visualization of increased amino acid transport that occurs in prostate and other cancers. Blue Earth Diagnostics subsequently developed and advanced Axumin through U.S. and EU approvals for PET imaging of recurrent prostate cancer. Axumin PET imaging has informed healthcare decisions for more than 125,000 men with recurrent prostate cancer across the United States, where it is available at 1,300 imaging centers and widely reimbursed. In Europe, Axumin availability and reimbursement continue to expand, with additional access anticipated this year. The commercial success of Axumin has set the stage for applying Blue Earth’s proven expertise in developing and commercializing innovative radiopharmaceutical technology to new products and indications. We are committed to improving the lives of patients through innovative diagnostic solutions that empower the evolution of care for men with recurrent prostate cancer, and we look forward to helping even more patients in the future."

"The decision to offer post-prostatectomy radiation is complex, because conventional imaging can leave unanswered questions on the best approach for treatment planning," said co-principal investigator Ashesh B. Jani, MD, MSEE, FASTRO, Winship Cancer Institute of Emory University, Atlanta, Ga. "This research has found that integrating advanced PET imaging using 18F-fluciclovine into the treatment planning process allows us to do a better job of selecting patients for radiation therapy, guiding radiation decisions and planning, and ultimately, keeping our patients’ cancer under control. The group getting treatment guided by 18F-fluciclovine PET had a ‘cancer control rate’ of 75.5% at both three and four years; the group receiving treatment guided by conventional imaging had a ‘cancer control rate’ of 63% at three years and 51.2% at four years."

"The question that we wanted to answer in this study was whether the treatment plan effect informed by 18F-fluciclovine PET imaging had a positive effect in the lives of patients," said David M. Schuster, MD, FACR, Professor of Radiology and Imaging Sciences and Director of the Division of Nuclear Medicine and Molecular Imaging, Emory University. The EMPIRE-1 trial allowed us to determine whether using 18F-fluciclovine PET imaging influences patient outcomes for the better, and the significant results confirm that it does."

Authors on the The Lancet manuscript were: Ashesh B. Jani, Eduard Schreibmann, Subir Goyal, Raghuveer Halkar, Bruce Hershatter, Peter J. Rossi, Joseph W. Shelton, Pretesh R. Patel, Karen M. Xu, Mark Goodman, Viraj Master, Shreyas S. Joshi, Omer Kucuk, Bradley Carthon, Mehmet A. Bilen, Sherrie Cooper, Bridget Fielder, Olayinka A. Abiodun-Ojo, Vishal R. Dhere, and David M. Schuster. All authors are affiliated with Winship Cancer Institute of Emory University, Atlanta, Georgia.

About the EMPIRE-1 trial

The EMPIRE-1 (Emory Molecular Prostate Imaging for Radiotherapy Enhancement) trial (NCT01666808) study was a single-center-open-label, Phase 2/3, randomized controlled trial. It enrolled 165 patients (median age 61 years; inter-quartile range 55-68 years) whose cancer recurred after having undergone prostatectomies, but who later showed abnormal PSA blood test scores, indicating that their cancer had returned. All patients underwent conventional imaging (bone scan, CT or MRI) for initial treatment planning. Patients were then randomized 1:1 into two groups: the first receiving radiation therapy based on the initial treatment plans; the second receiving 18F-fluciclovine PET scans with treatment re-evaluated based on those findings. After three years, the study showed patients who were treated based on incorporating the 18F-fluciclovine PET imaging results had a higher event*-free survival rate (p=0.003), which persisted after four years (75.5% in the 18F-fluciclovine PET imaging arm, versus 51.2% in the conventional arm; p<0.0001). Provider-reported genitourinary or gastrointestinal side effects were similar between the two study groups.

*Events defined as biochemical or clinical recurrence or progression, or initiation of systemic therapy.

NOTE: This content is intended to provide information about Blue Earth Diagnostics’ business in the United States and Europe. Approval status and product label for Axumin varies by country worldwide.

For U.S. Readers:

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION ABOUT AXUMIN
INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On May 25, 2021 MaaT Pharma reported that final results from its Phase 1/2 ODYSSEE clinical trial have been published in the journal, Nature Communications (Press release, MaaT Pharma, MAY 25, 2021, View Source [SID1234580549]). The data demonstrated that the company’s initial product candidate, MaaT011, an autologous fecal microbiota transfer treatment, was safe and effective in fully restoring the gut microbiota in the 20 per-protocol analysis set of acute myeloid leukemia (AML) patients . In addition, the MaaT011 treatment showed short- and long-term signs of positive clinical outcomes including the reduction of both intestinal inflammation and gut carriage of antibiotic resistance genes. Topline data from the study had been previously presented in a poster presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018.

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Follow-up results from the trial also showed that only 17% (3/18) of the AML patients who received the MaaT011 intervention and subsequent allogeneic hematopoietic stem cell transplantation (allo-HSCT) developed gastrointestinal- graft -versus-host disease (GI-GvHD), a serious complication often resulting in high morbidity and mortality rates of up to 80%, suggesting a potential long-term protective effect of MaaT011 in these patients. The overall survival (OS) rate in the trial was 92% at six months and 72% at two years, which compares favorably with previously published studies in which the two-year OS ranged from 41.9% to 60% in this setting[1].

"The publication of peer-reviewed data in this renowned journal is a validation of the scientific rigor behind MaaT Pharma’s full-ecosystem restoration approach. The initial positive data from ODYSSEE paved the way for our enema and capsule formulations, MaaT013 and MaaT033, respectively, which are derived from pooling the intestinal microbial ecosystems of healthy donors. The full results from the study support our premise that a full-ecosystem microbiome therapeutic that can restore the high diversity and richness of the gut microbiota can provide a positive impact for patients with liquid tumors, including possibly in a prophylactic setting," commented John Weinberg, MD, Chief Medical Officer of MaaT Pharma. "We recently announced positive results for MaaT013 from our Phase 2 HERACLES clinical trial in graft-vs-host disease and our oral formulation, MaaT033, is currently being evaluated in a Phase 1b clinical study in acute myeloid leukemia patients; we expect to complete that trial in the fourth quarter of this year."

The standard treatment regimen for AML relies on intensive induction chemotherapy and treatment with antibiotics, which has been shown to dramatically alter the rich and diverse composition of the gut microbiome. As a result, host-microbiome interactions can be disrupted, resulting in pathological conditions including uncontrolled local immune responses, systemic inflammation, and increased incidence of comorbidities and complications. The study demonstrated that MaaT011 treatment successfully reestablished the disrupted gut microbiota back to baseline levels, qualitatively and quantitatively. Moreover, it drastically reduced proinflammatory bacteria that have been shown to dominate after intensive chemotherapy.

Professor Mohamad Mohty, MD, PhD, Professor of Hematology at Sorbonne University and Head of the Hematology and Cellular Therapy Department at the Saint Antoine Hospital in Paris, and senior corresponding author of the article added: "The results from the ODYSSEE study are profound because they suggest that restoring a functional gut microbiome ecosystem in heavily pre-treated acute myeloid leukemia patients can improve their outcomes. It is also impressive that MaaT011 treatment could likely reduce the risk of GvHD in the patients that received stem cell transplantation compared to standard expectations in this population."

The article titled, "Restoration of gut microbiota diversity with autologous fecal microbiota transfer in acute myeloid leukemia patients " summarizes the findings of the ODYSSEE trial (NCT02928523), a Phase 1/2 single-arm, multicenter, prospective, interventional trial in hospitalized patients with AML or high-risk myelodysplastic syndrome (MDS). A total of 25 patients were treated with MaaT011 and the efficacy results published were from those 20 patients that met the per-protocol analysis profile.

The Nature Communications publication is available online.

About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is a rare and aggressive cancer of the myeloid cells – immune cells that fight bacterial infections, defend the body against parasites, and prevent the spread of tissue damage – that progresses quickly and aggressively, and usually requires immediate treatment. The risk of developing AML increases with age; it is most common in people over 75 years.

On May 25, 2021 United Therapeutics Corporation (Nasdaq: UTHR) reported that Mr. James Edgemond, Chief Financial Officer and Treasurer of United Therapeutics, will provide an overview and update on the company’s business during a fireside chat session at the Jefferies Virtual Healthcare Conference (Press release, United Therapeutics, MAY 25, 2021, View Source [SID1234580565]).

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The session will take place virtually on Tuesday, June 1, 2021, from 3:30 p.m. to 3:55 p.m., Eastern Daylight Time, and can be accessed via a live webcast on the United Therapeutics website at View Source An archived, recorded version of the session will be available approximately 24 hours after the session ends and can be accessed at the same location for 90 days.

On May 25, 2021 Tavanta Therapeutics, a specialty pharmaceutical company, reported that the first patient has been dosed in a recently initiated global Phase 3 clinical trial evaluating TAVT-45 (abiraterone acetate) Granules for oral suspension (TAVT-45 granules), a novel and proprietary formulation of abiraterone acetate. In agreement with the U.S. Food and Drug Administration (FDA), the safety and efficacy of TAVT-45 Granules is being studied in a single Phase 3 trial as a treatment for metastatic castrate sensitive prostate cancer (mCSPC) and metastatic castrate resistant prostate cancer (mCRPC) (Press release, Tavanta Therapeutics, MAY 25, 2021, View Source [SID1234580581]). TAVT-45 Granules was designed as an alternative for patients who have difficulty swallowing (dysphagia), which can be a side effect of some cancer treatments and occurs more frequently in elderly patients. TAVT-45 was also developed to address some of the limitations of current abiraterone treatment, including low bioavailability, high variability in systemic exposure, and large food effect.

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"We are excited to be the first clinical trial site to dose a patient in this trial" said Dr. Robert Given, a urological oncologist at Urology of Virginia and a study investigator. "The current standard of care treatment requires patients to ingest multiple large tablets, and under strict fasting conditions due to the risk of increased and highly variable abiraterone exposures with food. In contrast, TAVT-45 Granules has the potential to provide the more than 3.2 million prostate cancer patients in the United States,1 specifically those with dysphagia, with an alternative option that would reduce pill burden."

This single Phase 3 registrational trial (NCT04887506) is a global, randomized, multi-center, open-label trial designed to evaluate the pharmacodynamic effect and safety profile of TAVT-45 Granules compared to Zytiga tablets, in combination with prednisone, in patients with mCSPC and mCRPC. The primary objective of the trial is to establish therapeutic equivalence between TAVT-45 Granules and Zytiga tablets. The secondary objective is to characterize the multiple-dose pharmacokinetic profile of TAVT-45 Granules in a cohort of patients. Tavanta has met and aligned with the FDA regarding the design of the single trial required for registration. The trial, which aims to recruit a total of 108 patients, is expected to complete enrollment within the second quarter of 2022.

"As one of the most frequently diagnosed cancers in men in the United States,2 prostate cancer affects a large population of men with unmet medical needs, like dysphagia, and not all can be met with current treatment options," said Lynne Powell, chief executive officer of Tavanta Therapeutics. "Dosing the first patient in this pivotal TAVT-45 study reinforces Tavanta’s commitment to provide an alternative formulation of abiraterone acetate for prostate cancer patients. Importantly, this novel formulation may support improved bioavailability and reduced systemic variability using a lower dose of drug compared to the standard of care, which may ultimately help patients achieve better clinical outcomes."

Powell added, "Tavanta is advancing a diverse pipeline of specialty drugs designed to bring clinically meaningful benefits to patients with unmet medical needs. We are excited that TAVT-45, our most advanced product candidate, has reached this important clinical development milestone."

About TAVT-45 Granules
TAVT-45 Granules is an enhanced formulation of abiraterone acetate for the treatment for prostate cancer. TAVT-45 Granules was designed to be an improved formulation of the commercially available Zytiga (abiraterone acetate) tablets and developed using the High Throughput (HT) Matrix Screening Platform at Tavanta. When reconstituted with water or juice to yield an oral suspension, TAVT-45 Granules may increase the bioavailability of abiraterone and therefore allow a lower dose to be administered while also providing an alternative to patients who suffer from dysphagia or have difficulty swallowing tablets. In addition to the multiple large tablets required daily, other limitations of Zytiga include the requirement to be taken on an empty stomach and the high variability in systemic exposure. This high variability in systemic exposure has been shown to result in patients with low abiraterone plasma concentrations and exposure, which can lead to suboptimal clinical outcomes.3,4 It is anticipated that TAVT-45 treatment may be given regardless of food consumption and may result in less patients having sub-optimal abiraterone trough plasma concentrations.

On May 25, 2021 Knight Therapeutics Inc. (TSX: GUD) ("Knight") a pan-America (ex-USA) specialty pharmaceutical company, reported that Samira Sakhia, President and Chief Operating Officer, is scheduled to present at the Jefferies 2021 Virtual Healthcare Conference on Wednesday, June 2, 2021 at 10:30 AM ET (Press release, Knight Therapeutics, MAY 25, 2021, View Source [SID1234580629]). A live webcast of the event will be available at the following link: Event. A copy of the presentation will be available at www.gud-knight.com.

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