On September 2, 2016 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that during the month of August it has enrolled 28 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, SEP 2, 2016, View Source [SID:1234514890]). Total patient enrollment for the trial is now 905 as of August 31, 2016.

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The Multikine Phase 3 study is enrolling patients with advanced primary (not yet treated) squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.

About Multikine

Multikine is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line (before any other, right after diagnosis) treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world-renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF.

On September 1, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported an update on its program for developing treatments for serious brain cancers that involve constituents of the Cannabis plant. These Cannabis-based cancer therapies, like PharmaCyte’s pancreatic cancer therapy, will involve the use of its Cell-in-a-Box technology. The cancer "prodrug" that will be activated (converted to their cancer-killing forms) by the cells inside the Cell-in-a-Box capsules are constituents of the Cannabis plant known as cannabinoids. PharmaCyte has contracted with the University of Northern Colorado (UNCO), led by Dr. Richard M. Hyslop, to conduct the research related to PharmaCyte’s medical Cannabis program. UNCO has obtained all of the necessary approvals and has now received research Cannabis to enable it to advance PharmaCyte’s program.

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The Chief Executive Officer of PharmaCyte, Kenneth L. Waggoner, commented on the progress being made by UNCO, "Obtaining permission to perform Cannabis-related research has been a rigorous and time-consuming process. First, a detailed research plan had to be submitted to, and approved by, the U.S. Drug Enforcement Agency (DEA) before a Schedule 1 license could be issued. Then the research plan and a request for Cannabis plant material had to be submitted to the National Institute on Drug Abuse (NIDA), the only federally approved source of Cannabis, which is grown at a facility at the University of Mississippi. Only after NIDA approved the research plan was Cannabis for research issued to UNCO. Now that all of these governmental approvals have been obtained and UNCO has received the research Cannabis, we are finally able to build upon the firm foundation that had been laid in our quest to develop targeted cannabinoid cancer chemotherapies that utilize the Cell-in-a-Box technology."

The process being used to develop cannabinoid-based treatments involves three basic steps. First, suitable cannabinoid prodrugs or their precursors that are safe and possess few, if any, side effects must be identified. Second, a unique human cell line that manufactures an enzyme that "activates" the cannabinoid prodrug must be developed. This involves identification of the specific gene that encodes for the production of the enzyme and then "transfecting" or inserting the gene into human cells as was done for PharmaCyte’s pancreatic cancer therapy. Third, the engineered cells must be encapsulated utilizing the Cell-in-a-Box technology. The product will then be ready for testing in various cancer cell lines, animal models and ultimately humans.

UNCO researchers have developed and standardized systems and protocols for isolating and utilizing "model" cannabinoid compounds. Further, various types of cells have been cultured and then screened for the appropriate prodrug-activating enzymatic activity, some "target" genes have been amplified, and preliminary dosing and pharmacokinetic studies have been performed. Current and future research is focused on: (i) the synthesis and amplification of specific genes that produce the cannabinoid prodrug-activating enzymes; (ii) transfection of human cells with these genes; and (iii) testing of the ability of these transfected cells to activate cannabinoid prodrugs. Candidates for cannabinoid prodrugs to be studied include the "acidic" forms of the cannabinoids cannabidiol (CBDA) and tetrahydrocannabinol (THCA).

On September 1, 2016 Novocure (NASDAQ: NVCR) reported that data showing Tumor Treating Fields (TTFields) in combination with paclitaxel is therapeutically effective against ovarian cancer cells in vitro and in vivo has been published by the International Journal of Cancer (Press release, NovoCure, SEP 1, 2016, View Source [SID:1234514873]). This Novocure preclinical research is the first to demonstrate that TTFields in combination with paclitaxel may be a potentially effective strategy for the treatment of ovarian cancer.

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In vitro application of TTFields alone to human ovarian cancer cell lines led to significant reductions in cell counts compared to untreated cells. TTFields treatment combined with paclitaxel resulted in additive and even synergistic efficacy depending on the ovarian cell line treated. In vivo, TTFields plus paclitaxel led to a significantly larger anti-tumor effect than either treatment alone.

Novocure also examined the feasibility of local delivery of TTFields to the human abdomen using finite element mesh simulations, a commonly used technique for calculating electric field distribution in complex geometries like the human body. These simulations demonstrated that electric fields intensities inside and in the vicinity of the ovaries are within the range of intensities required for effective treatment with TTFields.

"Treatment with TTFields is broadly applicable and has shown a consistent antimitotic effect in our preclinical and clinical research over the last 16 years," said Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. "Novocure is committed to increasing the understanding of the mechanisms of action and potential clinical utility of TTFields in multiple solid tumors through the presentation and peer-reviewed publication of high quality data."

Based on these preclinical results, Novocure initiated the INNOVATE trial, an open-label, phase 2 pilot study of TTFields in combination with weekly paclitaxel for the treatment of recurrent ovarian cancer. The INNOVATE trial is fully enrolled, and Novocure expects to share data at its research and development day on Monday, Dec. 12, 2016.

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women in the United States. The National Cancer Institute estimated that in 2015, there were approximately 21,000 new cases of ovarian cancer diagnosed and approximately 14,000 deaths in the United States. Ovarian cancer incidence increases with age, and the median age at time of diagnosis is 63 years old. The five-year survival rate is 44 percent, and the majority of patients present at advanced stage with 60 percent having metastatic disease. TTFields therapy is not approved for the treatment of ovarian cancer by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for ovarian cancer has not been established.

On OPKO Health, Inc. (NASDAQ: OPK), reported that it has completed its previously announced acquisition of Transition Therapeutics, Inc. (NASDAQ: TTHI, TSX: TTH), by way of a plan of arrangement (the "Arrangement") which was approved by Transition Therapeutics’ shareholders at their meeting held on August 25, 2016 (Press release, Opko Health, AUG 31, 2016, View Source [SID:1234514848]). Pursuant to the Arrangement, shareholders of Transition Therapeutics will receive an aggregate of approximately 6.4 million shares of OPKO common stock, or 0.1657 shares of OPKO common stock for each common share of Transition Therapeutics. The Arrangement was approved by the Ontario Superior Court of Justice in its final order dated August 29, 2016.

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"We are pleased to complete the acquisition of Transition Therapeutics as it provides us with two late-stage drug candidates, each of which holds exceptional market opportunity and has direct synergies with our clinical development pipeline," said Phillip Frost, M.D., CEO and Chairman of OPKO Health. "With the transaction complete, we look forward to advancing these promising programs to the benefit of patients suffering from Type II diabetes and obesity or certain male hormone related problems."

On August 31, 2016 Sunovion Pharmaceuticals Inc. (Sunovion) and Cynapsus Therapeutics Inc. (Cynapsus) (NASDAQ: CYNA) (TSX: CTH) reported that the companies have signed a definitive agreement under which Sunovion will acquire Cynapsus for US$40.50 per share in cash (Press release, Sunovion, AUG 31, 2016, View Source [SID:1234514849]). The transaction has received unanimous approval by the Board of Directors of both companies and values Cynapsus at approximately US$624 million (or approximately CAN$820 million). The acquisition will be funded with cash on hand. The transaction is expected to close in the fourth quarter of 2016 (third quarter of Sunovion’s fiscal year). This agreement reflects Sunovion’s global strategy to expand and diversify its portfolio in key therapeutic areas, including neurology.

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Through this transaction, Sunovion would acquire Cynapsus’ product candidate, APL-130277, which is designed to be a fast-acting, easy-to-use, on-demand treatment option for managing OFF episodes associated with Parkinson’s disease (PD).

"Parkinson’s disease is a chronic, progressive neurodegenerative disease that affects more than four million people around the world, and there is a significant need for new options to treat the OFF episodes associated with it," said Nobuhiko Tamura, Chairman and Chief Executive Officer, Sunovion. "We believe that APL-130277 is a novel late-stage candidate with the potential to make a real difference for patients and their families."

"The acquisition of Cynapsus is well-aligned with Sunovion’s focus on the innovative application of science and medicine to help people with serious medical conditions and complements our robust product pipeline," added Mr. Tamura. "We have high regard for the Cynapsus team and their work with the APL-130277 program."

"With its leadership in therapies for central nervous system disorders and commercial experience specific to neurology, we believe Sunovion is best suited to advance APL-130277 in the United States and other key markets," said Anthony J. Giovinazzo, President and CEO, Cynapsus. "This transaction culminates years of dedicated work by the Cynapsus team and represents significant value creation for our securityholders."

The board of directors of Cynapsus, after consultation with its financial and legal advisors and based, in part, upon the unanimous recommendation of an independent special committee of the board of directors, has determined that the arrangement is in the best interest of Cynapsus and the consideration to be received by shareholders of Cynapsus is fair to such shareholders. The board of directors unanimously recommends that Cynapsus shareholders and warrantholders vote in favour of the transaction at a special meeting expected to be held on or about October 13, 2016.

The proposed sale of Cynapsus follows a full consideration of alternatives aimed at optimizing shareholder value for the company. "We believe that the proposed transaction with Sunovion results in the best outcome for our shareholders," said Rochelle Stenzler, chair of the board of Cynapsus. "The transaction with Sunovion represents a significant premium to the current share price and we are recommending that our shareholders and warrantholders vote in favour of the transaction."

Pursuant to the terms of the definitive agreement, upon closing of the proposed transaction, shareholders of Cynapsus will receive US$40.50 per common share in cash, and holders of warrants and stock options will receive a cash payment equal to the difference between US$40.50 and the exercise price of such warrant or stock option. The offer of US$40.50 per common share in cash represents a premium of 123 percent based on the volume weighted average closing price of Cynapsus’ common shares on the NASDAQ Global Market for the last twenty trading days. The companies expect to close the transaction following required securityholder, court and regulatory approvals and satisfaction of certain other customary closing conditions.

The transaction will be completed by way of a plan of arrangement under the Canada Business Corporations Act. The arrangement will require approval of at least two-thirds of the votes cast by Cynapsus shareholders and warrantholders voting together as a single class at a special meeting of such securityholders of Cynapsus. Voting and Support Agreements in support of the transaction have been signed by all directors and officers of Cynapsus and the company’s largest shareholder representing in the aggregate, approximately 18.33 percent of the Cynapsus securities entitled to vote to approve the transaction.

Full details of the transaction will be included in the management information circular to be filed with the applicable securities regulatory authorities and mailed to Cynapsus shareholders and warrant holders within approximately two weeks. Assuming receipt of all required regulatory approvals, the parties expect to close the arrangement in the fourth quarter of 2016.

BofA Merrill Lynch serves as financial advisor, and Borden Ladner Gervais LLP and Troutman Sanders LLP serve as legal advisors to Cynapsus. Stifel, Nicolaus & Company, Incorporated serves as financial advisor and Fasken Martineau DuMoulin LLP serves as a legal advisor to the Special Committee of Cynapsus. Nomura Securities International, Inc. serves as exclusive financial advisor, and Goodmans LLP, Reed Smith LLP, and Gibbons PC serve as legal advisors to Sunovion.

Adagio Amending Agreement
Cynapsus and the former shareholders of Adagio Pharmaceuticals Ltd. ("Adagio") entered into a share purchase agreement dated as of December 22, 2011, as subsequently amended as of January 28, 2015 (the "Share Purchase Agreement"), pursuant to which Cynapsus acquired Adagio.

Cynapsus and the former shareholders of Adagio have amended the Share Purchase Agreement to provide, among other things, that if a change of control of Cynapsus, which would include the transaction with Sunovion, occurs before the successful completion and the first public announcement of the top-line data of the Final Safety Study (as defined in the Share Purchase Agreement), the CDN$2,500,000 of the purchase price still potentially payable to the former shareholders of Adagio shall be paid in cash (not common shares, as was originally contemplated in the Share Purchase Agreement) by Cynapsus, on the date on which the change of control transaction is completed.

As Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus, is also a director, officer and majority shareholder of Adagio, the amendment of the Share Purchase Agreement constitutes a related party transaction pursuant to Multilateral Instrument 61-101 and the policies of the TSX. The amendment was necessary, and appropriate, as it ensures that if Sunovion acquires all of the common shares of Cynapsus, it would not have an obligation to potentially issue shares to the former Adagio shareholders post-closing of such acquisition. The amendment was entered into at the same time as the arrangement agreement with Sunovion and therefore was not announced more than 21 days before its execution.

About APL-130277
APL-130277, a novel formulation of apomorphine, a dopamine agonist, is being developed as a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It has been studied in all types of OFF episodes, including morning OFF episodes. APL-130277 is in Phase 3 clinical trials and has not been approved by the U.S. Food and Drug Administration (FDA).

In the ongoing Phase 3 trial, CTH-300, the blinded safety data was corroborated by the DSMB findings, which were announced in the press release dated August 15, 2016. If the ongoing pivotal Phase 3 clinical trials are successful, it is expected that a New Drug Application (NDA) for APL-130277 will be submitted to the U.S. Food and Drug Administration (FDA) during the first half of 2017 under the abbreviated Section 505(b)(2) regulatory pathway. A pivotal European clinical program evaluating the safety and efficacy of APL-130277 in PD patients is expected to be initiated in the fourth quarter of 2016.