On June 7, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported that an article on the use of PV-10 for in-transit melanoma has been published by the Journal of Surgical Oncology (Filing, 8-K, Provectus Pharmaceuticals, JUN 7, 2016, View Source [SID:1234513115]). It expands on a presentation on the same topic given at the Royal Australasian College of Surgeons 85th Annual Scientific Congress, which was held 2-6 May 2016, in Brisbane, Australia.

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Titled "Intralesional PV-10 for In-Transit Melanoma—A Single Centre Experience," the article reports on use of PV-10 in the management of in-transit melanoma at the Peter MacCallum Cancer Centre, in East Melbourne, Victoria, Australia. The article was authored by Jocelyn Lippey et al. using retrospective analysis of data from nineteen patients receiving PV-10 at the center between 2010 and 2014.

Dr. Lippey reported, "After a median follow up of 11.7 months, disease control was achieved in 63% of patients. Five patients (26%) achieved a complete response, another five (26%) patients achieved a partial response, and two patients had stable disease (11%) at the time of last follow-up. Seventy-four percent (14/19) of patients had a clinical response at time of first follow-up (median time 21 days); range 8–91 days. Younger patients and those with smaller lesions were more likely to respond to treatment." The median age of patients in this series was 80 years.

Dr. Lippey also noted, "Ten patients did not have all lesions injected, primarily due to the number of lesions present. A bystander response was noted in un-injected lesions in 50% of patients who did not have all their lesions directly injected."
Eric Wachter, CTO of Provectus commented, "The results reported here are consistent with other evaluations of PV-10 in melanoma, and highlight both the rapid ablative properties and the immunologic features of PV-10 as an investigational ablative immunotherapy."

About the Peter MacCallum Cancer Centre
Peter MacCallum Cancer Centre is Australia’s only public hospital solely dedicated to cancer treatment, research and education. The hospital treats more cancer patients each year than any other hospital and the highly skilled medical, nursing and allied health team is backed by the largest cancer research group in Australia. Peter Mac has five locations across the state and provides services to patients from across Victoria and Australia and overseas. Multi-disciplinary teams, consisting of medical, surgical and radiation oncologists, nurses, radiation therapists and allied health professionals, develop comprehensive and coordinated treatment plans, ensuring patients get treatment and a team tailored to their individual needs. For more information, visit View Source

On June 7, 2016 Theragenics Corporation, a medical device company serving the cancer treatment and surgical product markets, reported it has reached an agreement with Nihon Medi-Physics Co., Ltd. ("NMP") for the distribution and sale of Theragenics’ brachytherapy seeds in Japan (Press release, Theragenics, JUN 7, 2016, View Source [SID:1234513117]). In 2003, NMP sold the first I-125 seeds for the treatment of early stage prostate cancer in Japan after the procedure was approved there. Under the agreement, Theragenics will become NMP’s exclusive radioactive seed supplier for Japan, and NMP will be Theragenics’ exclusive distributor for the sale of radioactive seeds in Japan. Manufacturing and marketing authorization in Japan for Theragenics’ AgX100 I-125 product was received in March 2016. Shipment of the AgX100 products to Japan commenced on June 3, 2016.

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"Theragenics remains committed to prostate brachytherapy around the world," stated Frank J. Tarallo, Chief Executive Officer of Theragenics Corporation. "We are honored to partner with Nihon Medi-Physics, a leader in supporting prostate brachytherapy in Japan since the first implant there in 2003."

Mr. Tarallo continued, "Japan is an exciting market with the potential to grow. Theragenics has been a recognized leader in prostate brachytherapy with over 35 years’ experience in the manufacture and supply of seeds. Our brachytherapy products have been used to treat over 175,000 men and are now used to treat prostate cancer in 16 countries around the world. Our expertise, product quality and innovation combined with NMP’s knowledge of the market will create a dynamic partnership serving physicians and patients in Japan."

Hisashi Shimoda, President and Representative Director of Nihon Medi-Physics Co., Ltd. commented, "We are pleased by our new alliance with Theragenics Corporation, a major brachytherapy seed supplier. We believe that Theragenics’ brachytherapy products will enhance our capabilities to meet the needs of healthcare providers in Japan. With our new Theragenics alliance, NMP will be able to offer a more diversified mix of products and services, boosting our ability to improve the quality of life of as many prostate cancer patients as possible."

On June 7, 2016 Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, reported that it has presented new prospective data for its MammaPrint 70-gene breast cancer recurrence assay at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, Agendia, JUN 7, 2016, View Source [SID:1234513121]).

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Results from the Prospective study Of MammaPrint in breast cancer patients with an Intermediate recurrence Score (PROMIS) show that MammaPrint can provide clear guidance on whether a patient should receive chemotherapy, compared to the indeterminate results from 21-gene assay (OncotypeDx). MammaPrint provides a definitive, binary High or Low Risk result for a patient’s cancer recurring and thus whether the patient needs more aggressive, or less aggressive therapy.

Between 38-67% of women tested in different studies using the 21-gene assay were classified as having an intermediate/indeterminate Recurrence Score (between 18 and 30).1 PROMIS evaluated 840 estrogen receptor (ER)-positive, lymph node (LN) positive or LN negative women across 58 US institutions who had previously received an intermediate/indeterminate risk score from the 21-gene assay. Patient samples were re‑tested using MammaPrint to refine the risk classification and provide additional treatment guidance.

Of the 840 intermediate risk patients, MammaPrint reclassified 55% (466) of these patients as High Risk and 45% (374) as Low Risk of the individual’s cancer recurring. No correlation between definitive MammaPrint results or the indeterminate 21-gene assay Recurrence Score could be identified, reinforcing the discordance between these assays and inability to use the results interchangeably. MammaPrint was shown to provide additional prognostic information independent from clinicopathological factors to support the treatment decision.

Based on the outcome of the MammaPrint test, 34% (282/840) of physicians changed their treatment decisions, preventing both under and over treatment: 37% (171/466) of the high risk patients had chemotherapy added to their treatment recommendation and 29% (108/374) of the low risk patients had chemotherapy removed from their treatment recommendation. Of the MammaPrint Low Risk patients who were previously indicated to receive chemotherapy based on the 21-gene assay results, 76% of patients (108/142) decided to forego chemotherapy, preventing unnecessary overtreatment in this group.

Medical oncologist Dr. Michaela Tsai from the Virginia Piper Cancer Center, Minneapolis, MN and primary author of the PROMIS poster commented, "Of 466 intermediate patients reclassified as High Risk by MammaPrint, 342 have an Recurrence Score ≤25 and were not recommended for chemotherapy by St. Gallen Guidelines (Goldhirsch, Winer et al. 2013), risking up to a 73% chance of under-treatment." She also noted, "79% of physicians reported that they had greater confidence in their treatment recommendations with MammaPrint."

Dr. William Audeh, Chief Medical Officer of Agendia said: "The clinical performance of MammaPrint and its ability to accurately inform and guide treatment decisions has been definitively proven by the recent presentation of the MINDACT trial at the 2016 AACR (Free AACR Whitepaper) meeting. This unique phase III prospective, randomized, controlled study provides the highest level of clinical evidence to MammaPrint above any other genomic assay for making adjuvant therapy decisions in early-stage breast cancer."

MINDACT included 6,693 patients and is a phase III, prospective, randomized controlled, clinical trial comparing the use of MammaPrint 70-gene assay with clinicopathological criteria (current standard of care) for selecting early-stage breast cancer patients who should be treated with adjuvant chemotherapy.

"The PROMIS trial showed the positive impact a binary test could have in the clinical setting by providing a clear risk assessment of the patient to physicians" said Mark Straley, Chief Executive Officer at Agendia. "MammaPrint is the only FDA-cleared assay for early-stage breast cancer patients of all ages, further validating the quality and clinical utility of the test."

1 Lo, Mumby et al. 2011, Sulayman, Spellman et al. 2012, Stemmer, Klang et al. 2013, Sparano, Grey et al. 2015

On June 7, 2016 Transgenomic, Inc. (TBIO), (NASDAQ: TBIO), reported that it is unveiling new data at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting further confirming the utility, speed and efficiency of its ICE COLD-PCR (ICP) technology for liquid biopsy detection of tumor mutations (Press release, Transgenomic, JUN 7, 2016, View Source [SID:1234513122]). The company is distributing a new educational handout at the meeting highlighting expanded concordance data showing that ICP plasma-based liquid biopsies detect all of the mutations identified using conventional tissue samples and also detect additional tumor alterations missed by conventional methods. Another educational handout presents data showing how use of ICP with Thermo Fisher’s Veriti thermal cycler expedites the testing of liquid biopsy samples, producing accurate results rapidly and efficiently.

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TBIO President and CEO Paul Kinnon commented, "As the highest profile cancer meeting of the year, ASCO (Free ASCO Whitepaper) is an excellent venue for presenting our expanded concordance study data further confirming the accuracy and superior performance of ICE COLD-PCR liquid biopsies for tumor detection and monitoring. We also are unveiling new study data highlighting the speed and efficiency of our ICP enrichment technology when used with a leading thermal cycler. We believe ICP’s accuracy, versatility and ease of use have the potential to enable wide adoption of routine genomic testing in cancer research and patient care, and the new data we are discussing at ASCO (Free ASCO Whitepaper) further supports the technology’s near-term clinical and commercial potential."

At the ASCO (Free ASCO Whitepaper) meeting, Transgenomic is distributing an educational report, "CRC Concordance Update – Stage IV CRC Sample Analysis with ICE COLD-PCRTM," which describes the results of an expanded concordance study assessing the ability of its multiplexed ICE COLD-PCR technology to detect a key tumor mutation in matched plasma samples compared to detection in the same patients using tissue and plasma samples analyzed using conventional Sanger sequencing methods. The expanded study included 32 patients with late stage colorectal cancer. Use of ICP-enriched testing resulted in an overall 96.9% concordance rate, with a 94.7% concordance rate for the mutation positive samples. In addition, actionable mutations were detected in two patient samples analyzed using ICP-enriched methods that were missed using conventional PCR with Sanger sequencing. Notably, the missed mutations were detected by ICP in both the plasma and tissue samples from these patients.

The researchers conclude that the high concordance rates achieved in the study and the ability of the ICP-enriched approach to detect relevant mutations missed by conventional methods support the clinical validity and utility of ICP-based liquid and tissue biopsies for mutation detection and monitoring in cancer patients.

Anil Vachani, MD, MS, Associate Professor of Medicine at the Hospital of the University of Pennsylvania and the Veteran’s Administration Medical Center and an investigator working with TBIO, commented, "The ability to accurately and efficiently detect tumor mutations from non-invasive blood-based patient samples is essential for realizing the potential of precision medicine approaches to transform cancer treatment. I welcome studies that increase our confidence in the validity of new technologies such as ICE COLD-PCR to help enable use of targeted and other precision treatment approaches."

A second TBIO educational handout, "Simple and Effective Clinical Testing Protocol Using ICE COLD-PCRTM across Targeted Cancer Gene Panels using the Veriti Thermal Cycler and Sanger Sequencing," details a new study that demonstrates how combining multiplexed ICE COLD-PCR with the Thermo Fisher Veriti thermal cycler expedites mutation detection and monitoring using liquid biopsy samples. It shows that with the Veriti thermal cycler, ICE COLD-PCR amplifications can be grouped based on temperature and primer annealing parameters to enable multiple amplicon enrichments in a single thermal cycler run. By combining the flexibility of the Veriti thermal cycler, the superior enrichment power of ICP and the rapid turnaround time of Sanger sequencing, liquid biopsy test results were generated in about four days, compared to total turnaround times of about four weeks for conventional tissue biopsies. Rapid results are an important advantage in cancer clinical testing and patient monitoring, where critical patient treatment decisions increasingly rely on up-to-date genomic data.

The study researchers note too that these results provide an opportunity for molecular diagnostic laboratories to reevaluate the use of Sanger sequencing for confirmation of mutation detection results from next-generation sequencing (NGS) platforms, and point out that by using this protocol, Sanger platforms can also be re-considered for front line mutation detection, with the potential to produce accurate results more rapidly and cost effectively than NGS platforms.

ICE COLD-PCR achieves its ultra-high sensitivity through selective amplification of mutant DNA. The result is up to a 500-fold increase in sensitivity in identifying mutations with the most precise sequence alteration detection rates available. ICP was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology to Transgenomic.

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.