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 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 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 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 (Press release, Provectus Pharmaceuticals, JUN 7, 2016, View Source [SID:1234513114]). 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."

The article can be found at View Source

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 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, reported the initiation of patient enrollment at Memorial Sloan Kettering Cancer Center (MSK) in the Phase I clinical trial evaluating its leading clinical development product MVT-5873 (HuMab-5B1) as a therapeutic treatment for patients with locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies (Press release, MabVax, JUN 7, 2016, View Source [SID:1234513112]). This is the second investigational site in the Phase I trial with patient recruitment currently underway at the Sarah Cannon Research Institute in Nashville, TN. MabVax previously announced receipt of authorization to proceed on the Investigational New Drug (IND) application filed from U.S. Food and Drug Administration (FDA).

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The open-label, dose-escalation Phase I therapeutic trial is evaluating the safety, tolerability and pharmacokinetics of MVT-5873. The first group of patients are being enrolled to assess safety and determine the recommended phase II dose of the antibody. A second patient group will establish the safety and dose of the antibody when administered with a standard-of-care chemotherapy. Eileen O’Reilly, MD, Associate Director for Clinical Research at MSK’s David M. Rubenstein Center for Pancreatic Cancer Research, is serving as the lead investigator at the investigational site.

"We are very fortunate to have an established and productive relationship with MSK," said David Hansen, MabVax President and CEO. "With the addition of this investigational site, we are now recruiting patients in our Phase I therapeutics trial at two highly respected institutions. We continue on track to announce interim results from this trial in the third quarter of 2016."

About HuMab-5B1:

MabVax’s HuMab-5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer. MabVax’s two lead antibody clinical programs utilize HuMab-5B1 as a naked antibody (MVT-5873) and as an immuno-PET imaging agent (MVT-2163).