On May 31, 2016 Transgene (Paris:TNG) (Euronext Paris: TNG), a company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases, reported that a poster on the ongoing Pexa-Vec Phase 3 trial in first line advanced HCC patients will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting on June 4th, in Chicago, IL, USA (Press release, Transgene, MAY 31, 2016, View Source [SID:1234512908]).

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Date and Time: Saturday, June 4, 2016, 8:00 a.m. – 11:30 a.m. CDT
Abstract Title: PHOCUS: A Phase 3 randomized, open-label study comparing the oncolytic immunotherapy Pexa-Vec followed by Sorafenib (SOR) vs SOR in patients with advanced hepatocellular carcinoma (HCC) without prior systemic therapy.
Abstract Number: TPS4146
Location: Hall A
Poster Board: #130b
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Presenter: Ghassan K. Abou-Alfa, MD – Memorial Sloan Kettering Cancer Center
NCT02562755

The abstract is available via the following link: View Source

PHOCUS trial: study initiated in January 2016 in HCC and actively recruiting

The PHOCUS clinical trial is a multinational, randomized Phase 3 open label study with the oncolytic immunotherapy, Pexa-Vec, in patients with advanced liver cancer, also known as hepatocellular carcinoma (HCC). This trial is being led by Transgene’s partner, SillaJen, Inc. The trial is evaluating the use of Pexa-Vec to treat HCC patients who are eligible for treatment with sorafenib (Nexavar), the only approved drug for advanced HCC.

The study is designed to enroll 600 patients who have not received prior systemic treatment for their cancer. Patients will be randomized 1:1 to one of two treatment groups: one which will receive Pexa-Vec followed by sorafenib and one which will receive sorafenib alone. The study will be conducted at approximately 140 sites worldwide, including in North America, Asia, Australia and Europe. SillaJen, Inc. reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for this global Phase 3 clinical trial. The primary endpoint of the study is overall survival. Secondary objectives include safety, as well as assessments for tumor responses between the two groups as measured by the following endpoints: time to progression, progression-free survival, overall response rate and disease control rate. To learn more about the trial, please visit View Source;rank=15 or www.pexavectrials.com.

About HCC (Hepatocellular carcinoma)

According to recent statistics (GLOBOCAN 2012), there were over 780,000 new cases of liver cancer worldwide in 2012 and over 745,000 deaths due to this disease. In Europe, there were estimated to be over 63,000 new cases and over 62,000 deaths from liver cancer. In the U.S., according to the American Cancer Society, over 35,000 new cases of liver cancer were expected to be diagnosed in 2015 and 24,000 deaths projected from the disease. Hepatocellular carcinoma is estimated to account for over 80% of all liver cancer. Currently there are few treatment options for advanced HCC patients, with only one drug, sorafenib, approved for the treatment of HCC. With a low five-year survival rate, especially for patients diagnosed at later stages of disease, and limited available therapies, new treatments are urgently needed.

About Pexa-Vec

Pexa-Vec (pexastimogene devacirepvec) is an oncolytic immunotherapy armed with a GM-CSF gene that promotes an anti-tumor immune response. Pexa-Vec is designed to selectively target and destroy cancer cells through three different mechanisms of action: the lysis (breakdown) of cancer cells through viral replication, the reduction of the blood supply to tumors through vascular disruption, and the stimulation of the body’s immune response against cancer cells. The lead indication for Pexa-Vec is hepatocellular carcinoma (HCC, liver cancer); trials in other cancer types are underway or planned.

SillaJen, Inc. has partnered with Transgene and Lee’s Pharmaceutical to develop and commercialize Pexa-Vec in major markets outside of the United States. Transgene has exclusive rights to develop and commercialize Pexa-Vec for the treatment of solid tumors in Europe, while Lee’s Pharmaceutical retains exclusive development and commercial rights in Hong Kong and The People’s Republic of China.

About SillaJen, Inc., Transgene’s Partner for Pexa-Vec

SillaJen, Inc. is a private, South Korean based biotechnology company headquartered in Busan South Korea, with satellite offices in Seoul, South Korea and San Francisco, CA. The company is focused on the development and commercialization of oncolytic immunotherapy products using the SOLVETM platform, including its lead product Pexa-Vec, which is currently in Phase 3 trials for the treatment of advanced primary liver cancer. Additional information about SillaJen is available at www.sillajen.com.

On May 31, 2016 Novocure (NASDAQ:NVCR) reported that the United States Food and Drug Administration (FDA) has approved its investigational device exemption (IDE) application to initiate the METIS trial. METIS is a multi-center, phase 3, pivotal, open-label study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC) (Press release, NovoCure, MAY 31, 2016, View Source [SID:1234512907]). 270 patients will be randomized 1:1 to receive either TTFields delivered at an output frequency of 150kHz with supportive care or supportive care alone after radiosurgery. The primary endpoint of the METIS trial is time to first cerebral progression. Secondary endpoints include, among others, time to neurocognitive failure, overall survival and radiological response rate following study treatments.

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TTFields are low-intensity, alternating electric fields delivered to the region of a tumor. TTFields exert forces on key electrically charged molecules essential to the mitotic process by which all cells divide. Interference with the normal functioning of these key molecules leads to cell death through multiple pathways. Treatment with TTFields, delivered via Optune, is currently approved in the United States and European Union for newly diagnosed and recurrent glioblastoma and in Japan for recurrent glioblastoma. METIS will be Novocure’s first phase 3 pivotal trial outside of glioblastoma. Novocure has ongoing or completed phase 2 pilot trials in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma.

"Novocure remains focused on increasing Optune adoption for glioblastoma and on developing TTFields for a variety of additional solid tumors," said Asaf Danziger, Chief Executive Officer. "We look forward to initiating a phase 3 pivotal trial in brain metastases given the unmet medical need. With the FDA IDE approval in hand, we are now working closely with trial sites and institutional review boards to open sites and enroll patients as quickly as possible."

About Brain Metastases

Metastatic cancer is cancer that has spread from the place where it first started to another place in the body. The exact incidence of brain metastases is unknown because no national cancer registry documents brain metastases, but it has been estimated that 98,000 to 170,000 new cases are diagnosed in the United States each year. Brain metastases cause an estimated 20% of all cancer deaths in the United States annually.

Tumor Treating Fields (TTFields) are not approved for the treatment of brain metastases by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for brain metastases has not been established.

On May 31, 2016 Blue Earth Diagnostics Ltd., a molecular imaging diagnostics company, reported that the U.S. Food and Drug Administration (FDA) has approved Axumin (fluciclovine F 18) injection, 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 (Press release, Blue Earth Diagnostics, MAY 31, 2016, View Source [SID:1234512906]). Axumin is the first FDA-approved F18 PET imaging agent indicated for use in patients with suspected recurrent prostate cancer.

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Prostate cancer is the second leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, recurrence occurs in up to one-third of patients. Recurrent disease is typically detected by a rise in PSA levels but often the location and extent of the disease cannot be detected by conventional imaging. Of those who experience biochemical recurrence, approximately one-third develop metastatic prostate cancer. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labeled with the radioisotope F18, enabling it to be visualized in the body with PET imaging.

"FDA approval of Axumin is a major milestone for Blue Earth Diagnostics, and we hope also for patients and their physicians," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics Ltd. "Axumin is our first approved product and we believe that it will benefit patients who are affected by biochemically recurrent prostate cancer. Axumin will be increasingly available in coming months through the national radiopharmacy network of our exclusive U.S. commercial manufacturer and distributor, Siemens’ PETNET Solutions."

"Approximately 180,000 new cases of prostate cancer are expected to be diagnosed in the United States in 2016, and between 20 to 30 percent of patients receiving primary therapy will develop biochemically recurrent disease," said Brian F. Chapin, M.D., Assistant Professor, Department of Urology, The University of Texas MD Anderson Cancer Center. "There is a need for clinical imaging techniques that can detect and localize suspected recurrent prostate cancer to facilitate the most appropriate patient management decision. Current commercially available imaging techniques have some limitations in terms of identifying recurrent tumors, which may impact subsequent patient management decisions. Additionally, many patient care options for men with suspected recurrent prostate cancer have uncertain benefits that may not justify the risk of side effects. New imaging procedures that can provide reliable information can be useful tools for effective patient management and care."

"An imaging agent with sufficient diagnostic performance to adequately detect and localize recurrent prostate cancer can provide referring physicians with actionable information to guide biopsy and inform management decisions for their patients," said David M. Schuster, M.D., a Georgia Research Alliance Distinguished Cancer Scientist, Associate Professor of Radiology and Imaging Sciences, and Director of the Division of Nuclear Medicine and Molecular Imaging at Emory University School of Medicine. "The fluciclovine molecule in Axumin was originally developed at Emory by Mark Goodman, Ph.D., and detects the upregulation of amino acid transport that occurs in prostate cancer and can potentially identify recurrent prostate cancer more reliably than conventional imaging techniques. The product will be convenient for patients and imaging facilities, as it can be made widely available and the entire imaging procedure can typically be completed in less than 30 minutes."

The FDA-approved prescribing information provides summaries from two clinical studies of Axumin, including an evaluation of Axumin images from 105 patients by three independent readers who were unaware of the clinical details of each patient or whether the biopsy of the prostate gland was positive or negative for cancer. On average, a correct image finding was identified in 77% of patients (range: 75%-79%). For cancer outside the region of the prostate, a correct image finding for cancer was identified in an average of 90% of patients (range: 88%-93%). The results seem to be affected by PSA levels with, in general, lower PSA levels in patients with negative scans than in those with positive scans. In patients with PSA levels ≤ 1.78 ng/mL, 15 of 25 had a positive scan, with 11 confirmed as positive by histology; 71 of 74 patients with PSA levels > 1.78 ng/mL had a positive scan, of which 58 were confirmed as positive (see full U.S. prescribing information at www.axumin.com).

Axumin will be commercially available through the national radiopharmacy network of the company’s exclusive U.S. commercial manufacturer and distributor, Siemens’ PETNET Solutions. Initial commercial production of Axumin is underway at certain regional radiopharmacies, and increasingly broader availability is planned in coming months.

Both Emory University and inventor Goodman, Professor of Radiology and Imaging Sciences and Director of the Radiopharmaceutical Discovery Lab at Emory, are eligible to receive royalties for this technology.

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 / 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.

About Positron Emission Tomography (PET) Imaging

Positron emission tomography (PET) is an imaging test that uses a special type of scanner in conjunction with a radiolabeled tracer (a molecular imaging agent) to visually examine biochemical processes in the body. PET scan images depict biological function and are complementary with technologies which show anatomical information, such as computed tomography (CT) scans or magnetic resonance imaging (MRI).

On May 31, 2016 Blaze Bioscience, Inc., the Tumor Paint Company, a biotechnology company focused on guided cancer therapy, reported that the company’s Senior Vice President of Development, Dennis Miller, Ph.D., will present at the American Society of Surgical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting, taking place in Chicago, IL on June 3-7, 2016 (Press release, Blaze Bioscience, MAY 31, 2016, View Source [SID:1234512904]).

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The poster presentation, titled "Phase 1 Dose Escalation and Expansion Safety Study of BLZ-100 in Pediatric Subjects with Primary Central Nervous System Tumors," will highlight the company’s first study in the pediatric population.

Details of the poster presentation are as follows:
Trials in Progress Presentation – Pediatric Oncology Session
Date: Monday, June 6, 2016
Time: 8:00 AM – 11:30 AM CDT
Location: Hall A Poster
Number: 274b
Abstract Number: TPS10584

About BLZ-100
BLZ-100 is the first product candidate from Blaze’s Tumor Paint platform and consists of an Optide (optimized peptide) and a fluorescent dye, which emits light in the near-infrared range. Tumor Paint products are designed to provide real-time, high-resolution intraoperative visualization of cancer cells, potentially enabling more precise, complete resection of cancer throughout surgery. Preclinical utility of Tumor Paint technology has been demonstrated in a wide range of cancer types. BLZ-100 is an investigational agent currently in multiple Phase 1 proof-of-concept clinical studies to evaluate the safety and imaging characteristics of BLZ-100 in solid tumors, including brain, breast, lung, prostate, and colorectal cancer. More details about on-going trials are available at www.blazebioscience.com or www.clinicaltrials.gov.

On May 31, 2016 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported details relating to two poster presentations at the upcoming 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7 in Chicago, Illinois (Press release, Onconova, MAY 31, 2016, View Source [SID:1234512903]).

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Rationale and Mechanism of Action for Rigosertib/Azacitidine Combination Therapy

Poster Presentation with Discussion*
Abstract Number: 7020
Title: Rigosertib (RIG) in combination with azacitidine (AZA) to modulate epigenetic effects and to overcome clinical resistance to hypomethylating agents (HMA) in myelodysplastic syndromes (MDS).
Session Name: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date: Monday, June 6, 2016
Time and Location: 8:00 AM — 11:30 AM, McCormick Place, Hall A
Presenter: Pratima Chaurasia, PhD, Icahn School of Medicine at Mount Sinai

*Poster discussion session on Monday, June 6, 2016 from 11:30 AM — 12:45 PM

Design of Phase 3 INSPIRE Trial for Second-line Higher-risk Myelodysplastic Syndromes

Poster Presentation
Abstract Number: TPS7077
Title: INSPIRE: A randomized phase III trial of intravenous rigosertib in patients with higher-risk myelodysplastic syndromes (HR-MDS) after failure of hypomethylating agents (HMAs)—Study design informed by subgroup analyses of ONTIME.
Session Name: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date: Monday, June 6, 2016
Time and Location: 8:00 AM — 11:30 AM, McCormick Place, Hall A
Presenter: Guillermo Garcia-Manero, MD, MD Anderson Cancer Center, Houston, TX