On June 7, 2016 Blue Earth Diagnostics Ltd., a molecular imaging diagnostics company, and Siemens’ PETNET Solutions, Inc., a wholly-owned subsidiary of Siemens Medical Solutions USA, Inc., reported the commercial availability of Axumin (fluciclovine F 18) injection in the United States (Press release, Blue Earth Diagnostics, JUN 7, 2016, View Source [SID:1234513123]). Axumin is a novel molecular imaging agent indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen (PSA) following prior treatment. Axumin was approved by the U.S. Food and Drug Administration (FDA) on May 27, 2016, and is the first FDA-approved F-18 PET imaging agent indicated for use in patients with suspected recurrent prostate cancer.

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"Blue Earth Diagnostics is extremely pleased to be working with Siemens’ PETNET Solutions, the leading supplier of PET radiopharmaceuticals in the United States; we both share a passion for PET molecular imaging, and for providing imaging tools to improve patient management."
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Axumin will be commercially available this month through Blue Earth Diagnostics’ manufacturer and exclusive distributor in the United States, Siemens’ PETNET Solutions. Initial commercial production of Axumin will be underway at certain Siemens’ PETNET Solutions radiopharmacies, with increasingly broader availability planned in the coming months.

"We are tremendously pleased with FDA’s recent approval of Axumin for suspected biochemically recurrent prostate cancer, and hope that this will make a real difference to patients and their physicians," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics Ltd. "Blue Earth Diagnostics is extremely pleased to be working with Siemens’ PETNET Solutions, the leading supplier of PET radiopharmaceuticals in the United States; we both share a passion for PET molecular imaging, and for providing imaging tools to improve patient management."

"This is a significant milestone for the PET industry, as this is the first proprietary F-18 labeled agent for an oncology indication approved by the FDA. And, being F-18 labeled enables efficient distribution and wide patient access," said Barry Scott, head of Siemens’ PETNET Solutions. "Through our broad network of radiopharmacies we are able to increase access to PET tracers, like Axumin, helping healthcare providers to address society’s most challenging diseases. We are proud to work with Blue Earth Diagnostics as the U.S. commercial supplier making Axumin available to imaging centers and their patients."

Blue Earth Diagnostics and Siemens’ PETNET Solutions welcome visitors to the upcoming SNMMI meeting to visit their exhibit booths. Blue Earth Diagnostics is at Booth 337; Siemens’ PETNET Solutions is at Booth 431.

About AxuminTM (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following initial therapy. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues, and is labeled with the radioisotope F18 for PET imaging. Axumin was approved by the U.S. Food and Drug Administration on May 27, 2016 following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications, such as glioma.

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.

Full Axumin prescribing information is available at www.axumin.com.

About Prostate Cancer/Recurrent Prostate Cancer

Prostate cancer is the second leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, the disease recurs in up to one-third of patients. In some patients recurrent disease is detectable only by a rise in prostate specific antigen (PSA) levels, yet the location of the recurrence cannot consistently be located by conventional imaging, severely limiting treatment guidance for these patients.

On June 6, 2016 Galera Therapeutics, Inc., a clinical-stage biotechnology company developing new treatments for cancer patients, reported the presentation of data from a Phase 1b/2a clinical trial of GC4419, an investigational drug candidate for the reduction of chemoradiotherapy-induced oral mucositis (OM), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (Press release, Galera Therapeutics, JUN 7, 2016, View Source [SID:1234513124]). Study results suggest that GC4419 may reduce the incidence, severity and duration of severe OM in patients receiving chemoradiation therapy for the treatment of head and neck cancer, particularly when GC4419 is administered for the duration of chemoradiation therapy.

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The Phase 1b/2a trial assessed the safety and pharmacokinetics of GC4419, administered intravenously prior to each dose of intensity modulated radiotherapy (IMRT) and cisplatin therapy, in 43 patients evaluable for OM. Study endpoints also included assessments of the incidence, time to onset, duration, and severity of OM and initial tumor outcomes for several dosing schedules of GC4419. The study demonstrated that, compared to historic controls, GC4419 appeared to delay onset, shorten the duration and decrease the incidence of severe OM (defined as WHO Grades 3 and 4 OM). The data also showed that the effect of GC4419 was greater if the treatment was administered for the entire duration of IMRT, with larger reductions in all grades of OM experienced by patients receiving full therapy (6-7 weeks) compared to patients receiving partial therapy (3 weeks). For example, investigators reported that the cumulative overall incidence of Grade 4 OM was 25 percent in patients in the 3 week cohort, while patients receiving full therapy had 0 percent. The median duration of severe OM was 2.5 days in patients receiving full therapy, far shorter than the 3-4 week duration in matched historical controls. Patients who received partial therapy still experienced less than 25 percent of the duration of severe OM than reported for matched historical controls.

GC4419 had a safety profile consistent with the IMRT and cisplatin regimen. The most common adverse events were attributable to chemotherapy or head and neck cancer. The plasma half-life of GC4419 was approximately 1.5 hours, with minimal accumulation after repeated dosing. Only 4.3 percent of patients required breaks in IMRT of 5 consecutive fractions or more, as opposed to 15% in published reports of other studies of OM in comparable patients. Patients followed for up to 12 months after completion of IMRT have showed no evidence of tumor protection from GC4419 treatment, with follow-up ongoing.

"We are pleased to share the promising results of the Phase 1b/2a trial, which offer early insight into the potential safety profile and clinical benefit of GC4419 in reducing severe oral mucositis in patients with head and neck cancer," said J. Mel Sorensen, MD, President and CEO of Galera. "These findings support the continued clinical development of GC4419, as well as our pipeline of breakthrough drugs targeting oxygen metabolic pathways. Enrollment in a randomized Phase 2 trial of GC4419 is currently underway. In addition, we are conducting IND-enabling work on orally active dismutase mimetics."

About Oral Mucositis (OM)
OM is a common debilitating side effect of radiation treatment in head and neck cancer (HNC) patients. Severe OM, defined as Grade 3 or 4 OM on the World Health Organization Oral Mucositis Scale, occurs in 60 to 80 percent of HNC patients who receive radiation therapy. Importantly, severe OM may result in interruptions in radiation treatment, which can compromise the otherwise good prognosis for tumor control in many of these patients. In addition, patients suffer significant pain, may develop serious infections, and may be unable to eat solid food or even drink liquids. Further, the costs of managing these side effects are substantial, particularly when hospitalization and/or surgical placement of PEG tubes to maintain nutrition and hydration is required. There is currently no drug approved to prevent or treat severe OM in head and neck cancer patients.

About GC4419
GC4419 is a superoxide dismutase mimetic, a small molecule drug that selectively targets the superoxide pathway by supplementing the activity of the superoxide dismutase enzyme family to accelerate the conversion of superoxide to hydrogen peroxide. This mechanism is thought to block the large burst of superoxide induced by radiotherapy, the initiating step in the development of OM, and has been shown to be protective of normal tissue but not tumor. In preliminary clinical studies, GC4419 markedly delayed the onset, shortened the duration and decreased the incidence of severe OM when administered intravenously prior to each dose of intensity modulated radiotherapy (IMRT) and cisplatin. GC4419 has now entered randomized Phase 2 development for the reduction of severe OM associated with chemoradiotherapy in head and neck cancer.

On June 7, 2016 Oxford University Innovation reported that it will be renamed Oxford University Innovation, in order to enhance the already strong links between Oxford University Innovation and the University1 (Press release, Oxford University Innovation, JUN 7, 2016, View Source [SID1234520264]). This will strengthen awareness of the company and its services within the wider University, and better portray the University’s ownership of the company.

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With a record 16 spinout companies launched and more than 450 academic consultancy contracts signed in the last 12 months, innovation activity in Oxford University is successful, growing, and making a significant contribution to the local economy. Professor Ian Walmsley, Pro-Vice-Chancellor (Research and Innovation) at the University of Oxford, added his voice to the recent Oxfordshire Green Paper2 concerning the future of the region, saying: "We are very pleased that the key regional leaders have joined to frame a vision for the future of Oxfordshire that brings together their aspirations for economic growth with improved quality of life and how innovation can contribute to achieving this vision."

Support for enterprise and innovation is at the heart of the University’s Strategic Plan3. The Oxford University Innovation Working Group4 recognised the vital role of Isis Innovation in technology transfer as a key service to Divisions, and made recommendations to establish still firmer connections. Various practical steps have already been taken to meet this objective, including establishing regular staffing at hotdesks in University departments. The new company name and branding – being introduced later this month – will further reinforce this.

An additional, secondary, consideration was the similarity of the current name to so-called Islamic State, which caused occasional business issues such as emails being blocked. However, the overriding reason for change – clearer definition of the link to the University – was compelling in its own right, and received unanimous support in our consultation process.

Managing Director of Isis Innovation, Linda Naylor, said, "Commercialising University research and expertise is important to enable wider society to benefit from the work of our world-leading academics. By changing our name to Oxford University Innovation the breadth of support from the University for entrepreneurial researchers will be more visible. We will also benefit from the global brand recognition of the University, allowing us to attract more clients and investors for the Intellectual Property-based technologies and for the many services that we provide to increase engagement with researchers. More successful engagements will contribute to greater impact from researchers’ work as well as greater financial returns to the University and individual researchers."

Further new initiatives supporting innovation within the University will be announced over the coming months.

On June 7, 2016 Celgene Corporation (NASDAQ:CELG) reported the presentation of a study comparing treatment patterns, healthcare costs and overall survival between African American and Caucasian Medicare beneficiaries with newly diagnosed multiple myeloma (Press release, Celgene, JUN 7, 2016, View Source [SID:1234513105]). The study, which was presented by Dr. Sikander Ailawadhi of the Mayo Clinic at a poster session during the 52nd ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, Ill, discussed disparities observed in treatment initiation between the two studied populations and the impact of these disparities on patient outcomes.

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"African Americans may be more at risk for developing multiple myeloma than Caucasians, however, they often can have a better prognosis when they get the proper care," said Dr. Manali Patel of the Stanford Cancer Center and an investigator in the study. "Through studies like this, we are trying to better understand potential modifiable drivers of these disparities to improve outcomes for African Americans living with multiple myeloma."

The study found that elderly African Americans with multiple myeloma had lower rates of receiving access to autologous stem cell transplant (3% vs 6%, p < 0.01) and novel combination therapies (66% vs 74% among patients with pharmacological therapy, p < 0.01) compared to Caucasians with the disease. The median times from diagnosis to therapy initiation (2.3 vs 1.7 months, p < 0.05) and novel therapy initiation (5.3 vs 3.1 months, p < 0.05) were also significantly longer for African Americans than Caucasians. The study found, however, that overall survival (OS) was comparable between African Americans and Caucasians (26.7 vs 30.0 months, p = 0.27) and total healthcare costs were similar across cohorts, although African Americans had higher costs for hospitalizations, emergency visits, and skilled nursing facility.

The study evaluated 2,200 Caucasian and 536 African American multiple myeloma patients in the Surveillance, Epidemiology, and End Results Program (SEER) Medicare database from 2007 and 2011, with the index date being defined as the first date of diagnosis with multiple myeloma. Patients were required to be continuously enrolled in Medicare Part A, B, and D for six months before (baseline period) and at least six months after the index date (study period), unless they died.

"Treatment disparities exist between African American and Caucasian patients suffering from multiple myeloma," said Dr. Mohamad Hussein, Vice President of Global Medical Affairs for Celgene. "At Celgene, we believe it is imperative to improve education, awareness and treatment access among African Americans, particularly since they are more predisposed to being diagnosed with the disease."

Researchers determined that differences in disease aggressiveness and other clinical characteristics at baseline between African Americans and Caucasians should be explored in future studies as they can impact treatment outcomes.

Multiple myeloma is the second most common form of blood cancer in the United States, and the most common blood cancer among African Americans. African Americans are twice as likely to be diagnosed with multiple myeloma. Novel therapeutic advances made in multiple myeloma over the past decade have significantly improved outcomes for patients when they receive access to timely care and treatment.

To address this disparity in multiple myeloma, Celgene created the "Standing in the Gaap for African Americans with Multiple Myeloma" program in 2015 to raise awareness about how multiple myeloma affects African Americans differently and to improve the quality of care they receive. In addition to addressing treatment disparities and access for African Americans with multiple myeloma, the program is committed to understanding the genetic differences between African American patients and other patients to better guide current treatment decisions and future research. In addition, the program aims to improve enrollment of African American multiple myeloma patients in clinical trials, which is critical to accelerating knowledge gathering and new discoveries for this highly fatal disease.

On June 7, 2016 TapImmune, Inc. (OTCQB: TPIV), a clinical stage cancer immunotherapy company, reported that the Company has exercised its option agreement with Mayo Clinic and signed a worldwide license agreement to a proprietary HER2neu vaccine technology (Press release, TapImmune, JUN 7, 2016, View Source [SID:1234513125]). The license gives TapImmune the right to develop and commercialize the technology in any cancer indication in which the Her2neu antigen is overexpressed. This technology, developed in the laboratory of Keith Knutson, Ph.D. at Mayo Clinic, has completed Phase 1 clinical trials in HER2neu breast cancer patients.

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TapImmune recently announced positive Phase 1 clinical data for the technology in HER2neu breast cancer. The trial demonstrated that the experimental therapy was safe, well-tolerated, and provided a robust immune response across a broad patient population. Therefore, TapImmune plans to initiate a Phase 2 clinical trial at the start of 2017. Under the license agreement the Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration covering the clinical trial will be transferred to TapImmune.

Dr. Glynn Wilson TapImmune’s CEO stated "This agreement confirms our intent to further develop and commercialize TPIV 100 and TPIV 110, our novel HER2neu vaccine technology. The HER2neu antigen is a well-established therapeutic target. Our immediate plans are to complete development of a Phase 2 vaccine formulation and to establish clinical protocols for Phase 2 studies. We are excited by the recent Phase 1 data and our future clinical programs will be aimed at developing this leading vaccine candidate as a stand-alone therapy or in combination with other immunotherapies."

Mayo Clinic and Dr. Knutson have a financial interest in the technology described in this press release. Revenue Mayo receives is used to support its not-for-profit mission in patient care, education and research.