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Provectus Announces Name Change to Provectus Biopharmaceuticals, Inc. and Reincorporates in Delaware

On December 17, 2013 Provectus Pharmaceuticals, Inc. (OTCQB:PVCT) (http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, reported that shareholders in a special meeting voted to change the Company’s name to Provectus Biopharmaceuticals, Inc. and reincorporate in Delaware effective promptly upon regulatory filings in Delaware and Nevada. The company’s common stock will continue to trade under the symbol "PVCT" on the Over-the-Counter exchange. The name change and reincorporation proposals both had support from over 99% of shareholders who voted.

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Dr. Craig Dees, PhD, CEO of Provectus, said, "We thank our shareholders for their support as the Company takes these two important steps to protect their interests and communicate our plans for the future."

Dr. Dees added, "We felt that a change in the corporate name to ‘Provectus Biopharmaceuticals, Inc.,’ better communicates to the public the current and future nature of the Company’s business operations and enables the Company to better implement its business plan. In particular, the Company’s drug product candidates (pharmaceutical preparations) in both the oncology and dermatology therapeutic areas have either shown, or are expected to show through independent research, a capacity to harness the immune system of those patients treated. For oncology patients, this means using their bodies’ own disease-fighting capabilities to aid in reducing their tumor burden in various cancer indications. For dermatology patients, these same immune-system abilities can reduce the inflammation of their various inflammatory dermatoses. Both of these approaches to treat disease relate to properly utilizing the patient’s biologic or immune system and not just the direct treatment of his or her disease. Thus, ‘biopharmaceutical’ is a more apt term. The new name does not affect our business, operations, reporting requirements or stock price but will require a new CUSIP."

Dr. Dees also said, "Reincorporation in Delaware gives us more flexibility, clarity and predictability with respect to our corporate governance. Generally, the corporate laws of the State of Delaware are more comprehensive, widely-used and extensively interpreted than the corporate laws of other states, including Nevada. In addition, Delaware provides a recognized body of corporate law that is consistently interpreted by Delaware courts, which we believe will facilitate corporate governance by our officers and directors. All of this will enhance transparency to the benefit of our shareholders."

At the same time, Provectus announced that it has appointed Bob Miglani, Senior Director, External Medical Affairs at Pfizer Inc., to its Corporate Advisory Board. Bob also serves on the Board of Directors of the Alliance For US India Business (AUSIB), and as an Advisor on the Health Systems Strengthening Task Force at the Public Health Foundation of India (PHFI), where he is a leading advocate for elevating the Indian-American voice in the public conversation, both in the US and India. An active volunteer, Bob helps to mentor high school students in underprivileged areas around the world as part of the Albert Schweitzer’s Leadership for Life Program.

Mr. Miglani said, "I am delighted to join the Corporate Advisory Board of Provectus and look forward to using my extensive pharmaceutical industry knowledge and experience to help Provectus move its novel therapeutics forward on both the clinical and commercial fronts."

Dr. Dees stated, "We are thrilled to welcome Bob Miglani to our Corporate Advisory Board and are confident that he will make valuable contributions to our Company. Bob’s big pharma background and broad experience in sales, marketing, reimbursement strategy, medical affairs and alliance building are a unique fit with our strategic initiatives. His appointment will enhance our efforts to increase visibility and awareness among key audiences."

BIND Therapeutics and Amgen Amend Collaboration Agreement for Kinase Inhibitor Nanomedicine
Extends Option Exercise Period by Six Months

On December 12, 2013 BIND Therapeutics reported that it has amended its development and commercialization collaboration agreement with Amgen Inc. to extend the period during which Amgen may exercise its option by six months (Press release BIND Therapeutics, DEC 12, 2013, View Source [SID:1234500589]). BIND entered into a global collaboration agreement with Amgen on January 7, 2013 to develop and commercialize a kinase inhibitor nanomedicine for treating a range of solid tumors based on BIND’s platform for targeted and programmable nanomedicines and Amgen’s undisclosed proprietary kinase inhibitor. Under the agreement, Amgen had twelve months from the effective date to exercise its option to select a novel Accurin candidate for further development. The option period under the amended collaboration agreement has been extended to July 7, 2014 to allow for completion of the research plan. None of the other terms of the original agreement have been changed.

Amgen has the exclusive right to pursue development and commercialization of an Accurin kinase inhibitor against solid tumor targets to be selected by Amgen. Both companies are working together on preclinical development and agreed that Amgen would assume responsibility for any future development and commercialization. BIND is eligible to receive up-front and development milestone payments totaling $46.5 million, up to an additional $134 million in regulatory and sales milestone payments for the first therapeutic indication and additional payments for target exclusivity. BIND will receive tiered royalties on potential future sales.

(Press release, Boehringer Ingelheim, DEC 10, 2013, View Source [SID:1234505083])

Agios Presents Preclinical Data from Lead Programs at American Society of Hematology Annual Meeting

On December 9, 2013 Agios Pharmaceuticals reported that data from its lead programs were highlighted at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting this week in New Orleans (Press release Agios Pharmaceuticals, DEC 9, 2013, View Source;p=irol-newsArticle&ID=1883336&highlight= [SID:1234500778]).

Two presentations featured in vivo efficacy data in acute myelogenous leukemia (AML) for the company’s lead cancer metabolism programs targeting IDH1 and IDH2 mutations. In AML and other cancers, IDH1 and IDH2 mutations initiate and drive cancer growth by blocking maturation of primitive cells. The data presented at ASH (Free ASH Whitepaper) demonstrate preclinical single agent and combination efficacy of Agios’ IDH mutant inhibitors in patient-derived primary models of AML. Agios also presented data on AG-348, its lead inborn errors of metabolism (IEM) program candidate focused on pyruvate kinase deficiency (PK deficiency), a rare, inherited hemolytic anemia with no approved therapeutic options.

"We are excited to present data highlighting our IDH and PKR programs, which focus on genetically identified patient populations with limited or no therapeutic options," said Scott Biller, Ph.D., chief scientific officer at Agios. "These results highlight the potential for all three programs to provide significant clinical benefit to patients in the future."

Agios Presentations

"AG-221 offers a survival advantage in a primary human IDH2 mutant AML xenograft model," an oral presentation, provides strong preclinical in vivo evidence of AG-221’s potential clinical benefit for patients with tumors that harbor an IDH2 mutation. AG-221 is a potent, selective, orally available IDH2 mutant inhibitor currently in clinical trials for patients with hematologic malignancies. In this study, Agios scientists evaluated the efficacy of AG-221 as a single agent in a primary human model of aggressive AML carrying an IDH2 mutation. AG-221 caused a potent reduction in 2HG, the oncometabolite produced by the mutant IDH2 protein, found in the bone marrow, plasma and urine of engrafted mice. Treatment also induced a dose-dependent, statistically significant survival benefit in which all mice in the high-dose treatment group survived to the end of the study.
"IDH1 mutant inhibitor induces cellular differentiation and offers a combination benefit with Ara-C in a primary human IDH1 mutant AML xenograft model," a poster, evaluates the use of AGI-14100, a potent, selective, orally available IDH1 mutant inhibitor. Agios scientists treated a primary human mutant AML model with AGI-14100, either alone or in combination with low-dose chemotherapy (Ara-C). Researchers observed a significant decrease in tumor burden in peripheral blood in the model treated with AGI-14100 alone, and a more pronounced response, as measured by a simultaneous decrease in the bone marrow tumor burden, in the model that received combination therapy. The duration of response continued for three weeks after dosing of both drugs had been terminated. These data suggest that this combination therapeutic approach could be an important option for patients, to be explored in future clinical trials.
"Small Molecule Activation of Pyruvate Kinase Normalizes Metabolic Activity in Red Cells From Patients With Pyruvate Kinase Deficiency-associated Hemolytic Anemia," a poster, presents preclinical data supporting Agios’ lead IEM clinical candidate, AG-348, as a potentially effective approach to correcting the underlying pathology of PK deficiency. The results demonstrate that AG-348 potently activates a spectrum of PKR mutant proteins, the isoform of pyruvate kinase that is present in red blood cells, leading to a normalization of metabolic balance in patient-derived blood samples. These data support the hypothesis that drug intervention with AG-348 may restore glycolytic pathway activity and normalize red cell metabolism in vivo.

Oxford BioTherapeutics and Menarini Progress Enhanced Antibody for Acute Myeloid Leukemia as First Clinical Development Candidate in $1 Billion Oncology Investment Alliance

On December 9, December 2013 Oxford BioTherapeutics (OBT) and Berlin-Chemie (Menarini Group) reported that they have designated a novel enhanced antibody targeting acute myeloid leukemia (AML) as the first clinical development candidate under the companies’ strategic oncology collaboration (Press release Oxford BioTherapeutics, DEC 9, 2013, View Source [SID:1234500497]). The companies have initiated formal regulatory enabling studies to support an application for a clinical phase I trial in AML patients in H2 2014.
OBT and Menarini established their strategic partnership in October 2012, covering the development and commercialization of five of OBT’s proprietary antibody-based cancer therapies. Under the collaboration, Menarini contributes manufacturing, regulatory, pre–clinical, clinical and expertise, supported by investment of up to $1.1 billion. Futhermore Menarini is responsible for the clinical development, first up to the clinical proof of concept study, then to the full development and regulatory approval in its territories: Europe, Asia, and Latin America, while OBT is responsible for full development, approval and commercialization in North America and Japan.

The first of the partnership’s programs to progress into clinical development is an engineered antibody designed to induce antibody-dependent cellular cytotoxicity (ADCC) in AML and related hematological cancers. This first-in-class therapeutic incorporates BioWa ADCC-enhancing technology and has completed the in vitro/ex vivo proof-of-concept, demonstrating efficacy, and exploratory toxicology testing. The manufacturing process has been transferred and scaled-up at Menarini Biotech. Further regulatory pre-clinical studies and ex vivo experiments on AML blasts are now underway by Menarini.