On October 31, 2016 Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, reported the presentation of data from the Company’s HEAT Study, highlighting the curative potential for ThermoDox plus optimized radiofrequency ablation (RFA) in intermediate primary liver cancer, also known as hepatocellular carcinoma (HCC) (Press release, Celsion, OCT 31, 2016, View Source [SID1234516112]). The clinical data were presented by a leading liver cancer expert from South Korea, Professor Won Young Tak, M.D., Ph.D., Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea, on October 29, 2016 at the 3rd Asian Conference on Tumor Ablation (ACTA) in Seoul, Korea. Dr. Hyunchul Rhim from Samsung Medical Center in Soeul, Korea, is the Chairman of the 3rd ACTA Conference and a principal investigator on the Company’s OPTIMA Study.

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Professor Tak’s presentation, entitled "Thermo-Sensitive Drug Assisted Ablation," highlighted data from Celsion’s latest HEAT Study post-hoc analysis, which suggests an overall survival benefit of over two years in the large subgroup of patients treated with ThermoDox plus optimized RFA (RFA ≥ 45 minutes) as well as findings from preclinical studies demonstrating a direct correlation between the duration of RFA heating, or dwell time, and the concentration of doxorubicin localized to the liver.

"There is clear evidence that the duration of the RFA regimen is critical when treating patients with ThermoDox, and the totality of the data presented to date demonstrate that ThermoDox plus optimized RFA has a strong potential to serve as a curative therapy for patients with liver cancer," said Professor Tak, lead investigator in South Korea for the Company’s HEAT and OPTIMA studies. "The OPTIMA trial is designed to validate this approach in an indication where there exists a strong unmet need for effective treatment options."

The Phase III OPTIMA study is a global pivotal, double-blind, placebo-controlled study evaluating ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone.

"Our OPTIMA Study investigators continue to recognize the value of findings from the HEAT study, and their continued interest reinforces substantial and mounting support for and the de-risking of our ongoing global Phase III OPTIMA Study," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "The recent independent analysis conducted by the National Institutes of Health provides further confirmatory support indicating that the use of RFA for more than 45 minutes in patients treated with ThermoDox can have a correlative impact on reductions in tumor size and overall survival in patients with primary liver cancer."

Professor Tak’s presentation will be available on Celsion’s website under "News & Events – Scientific Presentations."
Celsion notes that NIH’s analysis will be discussed in detail during an oral session on Monday, November 28, 2016 at 1:50 pm CT during the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) to be held on November 26 – December 2, 2016 in Chicago, IL.

About Celsion’s Phase III OPTIMA Study
Celsion’s Phase III OPTIMA Study is a global pivotal, double-blind, placebo-controlled study. The study is expected to enroll up to 550 patients in over 75 clinical sites in the North America, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone. The primary endpoint for the trial is overall survival, which is supported by post-hoc analysis of data from the Company’s 701 patient HEAT Study, where optimized RFA has demonstrated the potential to significantly improve survival when combined with ThermoDox. The statistical plan for the OPTIMA Study calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC).

On 29 October 2016, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma", stock code: 600196.SH, 02196.HK) reported in its A-share announcement that Shanghai Henlius Biotech Inc. ("Henlius"), a holding subsidiary under its control, and AbClon Inc. ("AbClon") from Korea entered into a license agreement for monoclonal antibody AC101 (Press release, Fosun Pharmaceutical, OCT 31, 2016, View Source [SID1234517344]).

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AC101, an innovative monoclonal antibody developed by AbClon targeting gastric cancer and breast cancer, is currently under pre-clinical trial studies. Under the agreement, Henlius is granted the exclusive rights to develop and commercialize AC101 across the Great China region. This cooperation will put into play techniques and advantages of Henlius as an existing monoclonal antibody development platform of Fosun Pharma in further diversifying its product lines to enhance its competitiveness in the anti-tumor therapeutic area.

AC101 is the first novel monoclonal antibody discovered using AbClon’s proprietary antibody development platform New Epitope Screening Technology (Nest). Currently there is no similar product in any market worldwide. According to statistics from Global Data, the gastric cancer treatment market is projected to reach US$4.4 billion globally by the year 2024, and the HER2-positive breast cancer treatment market to reach US$12.7 billion by the year 2023.

At present, AC101 is still under pre-clinical trial studies and it is uncertain that it will be able to start clinical trials. Any clinical trial, registration, manufacture and other matters in relation to it in the relevant region is subject to approval of relevant pharmaceutical authorities.

Dr. Scott Liu, President and CEO of Shanghai Henlius indicated that, "Shanghai Henlius’ mission is to provide high-quality, affordable and accessible healthcare products worldwide. We are very excited to add another promising antibody product to our expanding portfolio. We believe AC101 in combination with the proprietary recombinant humanized anti-HER2 monoclonal antibody injection (trastuzumab biosimilar) developed by Henlius will enhance the efficacy against gastric cancer and breast cancer." Phase I clinical study for the proprietary recombinant humanized anti-HER2 monoclonal antibody (trastuzumab biosimilar) developed by Henlius has been completed and the results show that the new drug is safe and has the same efficacy as the corresponding proprietary drug Herceptin. Phase III clinical trial for the new drug will commence within this year.

Dr. Jong-Seo Lee, CEO of AbClon, also expressed his delight in having a licensing deal with Henlius, one of the most prominent monoclonal antibody pharmaceutical companies in China, and he looked forward to more partnerships with premier biopharmaceutical companies such as Henlius.

On October 31, 2016 DURECT Corporation (Nasdaq: DRRX) reported financial results for the third quarter of 2016. Total revenues were $3.7 million and net loss was $8.8 million for the three months ended September 30, 2016 as compared to total revenues of $4.7 million and net loss of $6.5 million for the three months ended September 30, 2015.
At September 30, 2016, we had cash and investments of $29.0 million, compared to cash and investments of $29.3 million at December 31, 2015. At September 30, 2016, we had $19.8 million in long term debt.
"We are pleased to have provided a separate update today on our DUR-928 program," stated James E. Brown, D.V.M., President and CEO of DURECT. "Regarding POSIMIR, we have switched over the majority of our active clinical trial sites in the PERSIST Phase 3 trial from Part 1 to Part 2, in which POSIMIR is compared head-to-head against bupivacaine HCL, and continue to add new sites as enrollment proceeds."
Update of Selected Programs:

• Epigenetic Regulator Program. DUR-928, our Epigenetic Regulator Program’s lead product candidate, is an endogenous, small molecule, new chemical entity (NCE), which may have broad applicability in several metabolic diseases such as nonalcoholic steatohepatitis (NASH), and in acute organ injuries such as acute kidney injury.
As reported in greater detail in a separate press release today, our first Phase 1b clinical trial in patients has progressed to the second cohort with a higher dose. While this study was not designed to assess the efficacy of DUR-928 as a therapy for NASH, we are pleased to be able to report that certain biomarkers for liver function and liver injury were reduced in the first cohort 12 hours after a single dose of DUR-928 as compared to before dosing. Collectively, the reduction of these biomarkers plus results from our animal and cell culture studies suggest potential therapeutic activity of DUR-928 for patients with liver disease. However, additional studies are required to evaluate the safety and efficacy of DUR-928, and there is no assurance that these biomarker effects will be observed in a statistically significant manner, or that DUR-928 will demonstrate safety or efficacy in treating NASH or other liver diseases in larger controlled trials. We have recently requested a pre-IND meeting with the U.S. Food and Drug Administration (FDA) as precursor to submitting an IND, which is required to enable a future liver disease clinical trial in the United States.
Our second Phase 1b clinical study with DUR-928, in patients with impaired kidney function (stage 3 and 4 chronic kidney disease), is underway in Australia. We recently held a pre-IND meeting with the Cardiovascular and Renal Products Division of the FDA; we anticipate utilizing feedback from that meeting as well as from our clinical advisors to file an IND which is required to enable a future kidney disease clinical trial in the United States.
• POSIMIR (SABER-Bupivacaine) Post-Operative Pain Relief Depot. POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER technology and is intended to deliver bupivacaine to provide up to 3 days of pain relief after surgery. We are in discussions with potential partners regarding licensing development and commercialization rights to POSIMIR, for which we hold worldwide rights. We are also continuing to evaluate the requirements for commercializing POSIMIR on our own in the U.S., in the event that we determine that to be the preferred route of commercialization.
In November 2015, we began enrolling patients for PERSIST, a POSIMIR Phase 3 clinical trial consisting of patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery. We began recruiting patients for this trial comparing POSIMIR to placebo. Based on recommendations from the FDA received subsequent to the start of the trial, in April 2016 we decided to amend the PERSIST trial. Starting in August 2016, we began implementing Part 2 of the PERSIST trial to evaluate POSIMIR against standard bupivacaine HCl rather than placebo as we have been doing in Part 1. We expect to enroll approximately 264 patients in Part 2 of PERSIST, and we expect this part of the trial to finish dosing patients in the third quarter of 2017. We believe that a positive outcome from this new trial design would result in a stronger NDA resubmission and potential commercial advantages. In a previous clinical trial of 50 patients in the same surgical model (laparoscopic cholecystectomy), POSIMIR was compared with the active control bupivacaine HCl, against which POSIMIR demonstrated in a post hoc analysis an approximately 25% reduction in pain intensity on movement for the first 3 days after surgery (p=0.024) and for the first 2 days after surgery (p=0.0198), using the same statistical methodology specified for the current trial. There can be no assurance that the PERSIST trial will replicate these results.

• REMOXY ER (oxycodone) Extended-Release Capsules CII. Based on our ORADUR technology, the investigational drug REMOXY ER is a unique long-acting formulation of oxycodone designed to discourage common methods of tampering associated with opioid misuse and abuse.
In September 2016, Pain Therapeutics (our licensee) received a Complete Response Letter from the FDA for REMOXY ER. Based on its review, the FDA has determined that the NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval. Pain Therapeutics has stated that it is evaluating the comments raised by the FDA and is consulting with outside experts.

• ORADUR-ADHD Program. ORADUR-Methylphenidate is an investigational drug that has the potential for rapid onset of action, long duration with once-a-day dosing, utilizes a small capsule size relative to the leading existing long-acting products on the market and incorporates our ORADUR anti-tampering technology. Orient Pharma, our licensee in defined Asian and South Pacific countries, has initiated a Phase 3 study in Taiwan and anticipates completing dosing the trial in 2016. We retain rights to all other markets in the world, notably including the U.S., Europe and Japan, and are engaged in licensing discussions with other companies.
• Business Development Activities. We have multiple programs that may potentially be licensed over the next 12-18 months. These include POSIMIR, DUR-928, ORADUR-ADHD (territories outside certain Asian and South Pacific markets), as well as various other programs which we have not described publicly in detail.

• Debt Refinancing. In July 2016, we refinanced our existing $20 million term loan with Oxford Finance into a new term loan that results in an extended maturity (to four years) and an extended interest only period (to 18 months).

• Upcoming investor conference. DURECT will be presenting at the Stifel Nicolaus Healthcare Conference at 4:30 pm Eastern time on November 15. The conference is being held at the New York Palace Hotel in New York. A live audio webcast of the presentation will be available by accessing View Source A live audio webcast of these presentations will also be available by accessing DURECT’s homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Audio Archive in the "Investor Relations" section.

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On October 31, 2016 ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("ProMetic" or the "Corporation") reported today that it has closed the acquisition of all the issued and outstanding common shares of Telesta Therapeutics, Inc, ("Telesta") by way of a plan of arrangement under the Canada Business Corporations Act (the "Acquisition") for a consideration of $0.14 per Telesta common share payable in ProMetic common shares (Press release, ProMetic Life Sciences, OCT 31, 2016, View Source [SID1234516121]).

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The number of common shares to be issued by ProMetic is based on the volume-weighted average closing price ("VWAP") of ProMetic’s common shares for the five (5) trading days prior to the closing date of the Acquisition. At the end of trading on the Toronto Stock Exchange on Friday, October 28, 2016, the 5 day VWAP of ProMetic’s common shares was $2.98. Accordingly, each Telesta common share was acquired for 0.04698 ProMetic common share.

Pierre Laurin, President and CEO of ProMetic stated: "We welcome Telesta’s shareholders decision to participate to ProMetic’s growth as they will benefit from our ability to further leverage Telesta’s assets. ProMetic represents a balanced, low-risk, high reward opportunity as we are getting ready to launch our first plasma-derived therapeutic, plasminogen, in mid-2017 followed by the sequential launches of several other plasma-derived products from our proprietary manufacturing platform. Furthermore, our small molecule fibrosis program is set to contribute further significant upside now that PBI-4050’s efficacy in humans has been demonstrated", added Mr. Laurin.

"Closing this transaction is both strategically and tactically significant for ProMetic for many reasons", commented Bruce Pritchard, Chief Operating Officer. He added, "It brings cash which extends our operating runway; a small group of key personnel who are highly complementary to our existing staff; tax losses to be used going forward; and lastly, a facility located in Belleville, Ontario with a recently refurbished part that could add quickly to our existing manufacturing output and in the longer term, the potential to provide additional plasma processing capacity. It also widens our trans-Canadian footprint, positioning us as a major supplier of plasma proteins to the Canadian market".

Concurrently with the Acquisition, the Corporation has closed a private placement entered into with Structured Alpha LP ("SALP"), an investment vehicle of Peter J. Thomson. This concurrent private placement was completed in connection with the exercise by SALP of its pre-emptive right. The private placement is for the subscription of 1,401,632 common shares of the Corporation at a price of $2.98 per common share. The proceeds from this private placement have been used to offset and reduce the total amount owed by ProMetic to SALP under its second amended and restated loan agreement by $4,176,863.36.

On September 30, 2016 MagForce AG (Frankfurt, Entry Standard, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, reported its financial results for the first half of 2016, ending on June 30, 2016, and operative highlights (Press release, MagForce, OCT 30, 2016, View Source [SID:SID1234515523]).

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Operative Highlights:

Brain Cancer NanoTherm(TM) Therapy at MagForce AG

In Europe, MagForce AG is continuing to expand the commercialization phase of its valuable NanoTherm(TM) therapy: The first phase was to install NanoActivators(R) in Germany and assist the neurosurgeons and radiologists as they became familiar with NanoTherm(TM) therapy and its applicability. The second phase was to initiate the Company’s commercialization efforts with the goal of increasing patient inquiries to 100 per month. The combination of clinical success and marketing efforts will result in the Company achieving the targeted patient inquiry level. MagForce is currently half way there. In the third phase, cross-border reimbursement processes have been optimized based on the fact that a majority of the patients requesting treatment require the implementation of the Cross-Border Directive of the European Union. However, the medical procedure for treating glioblastoma generally requires surgery and radiation resulting in the patient’s obligation to fund the country differential costs for surgery and radiation in his home country and the higher costs for these treatments in Germany, as well as for the NanoTherm(TM) therapy.

During 2016, MagForce has streamlined the implementation of the cross- border reimbursement process, however, due to the aggressiveness of glioblastoma, there is a limited time interval to achieve treatment. Toward that end, the Company will continue its efforts to increase the medical awareness of the value of NanoTherm(TM) therapy to allow earlier patient inquiries.

Phase four of the Commercialization Program will be to obtain domestic reimbursement for NanoTherm(TM) therapy in Germany and selected countries in the EU where MagForce has the CE Mark for the treatment of brain tumors.

As mentioned three months ago, Management is actively exploring financing options, such as third-party leases of NanoActivator(R) equipment, or other non-equity financing options in order to further accelerate MagForce’s expansion in Europe.

Prostate Cancer Therapy at MagForce USA, Inc.

In the USA, MagForce USA, Inc.’s has filed an Investigational Device Exemption (IDE) with the USA Food and Drug Administration (FDA) for NanoTherm(TM) therapy to treat Intermediate Risk Prostate Cancer in 2015. MagForce is still working with the FDA to update preclinical studies, which were conducted approximately ten years ago, to current US regulatory standards and continues making very good progress toward adapting NanoTherm(TM) therapy as a focal treatment for prostate cancer. NanoTherm(TM) therapy for the focal treatment of prostate cancer is viewed as a very promising complement to current treatment approaches. These preclinical studies are underway with interim results clearly supporting the earlier European data.

The purpose of the proposed Focal Thermal Ablation Registration study that will enroll up to 120 men is to demonstrate that NanoTherm(TM) can ablate cancer lesions for patients who have Gleason Score 7 prostate cancer and are under active surveillance. By ablating the lesions, patients will be able to maintain active surveillance and avoid surgery and other treatments with their well-known side effects.

"I am still confident we will achieve our original targets in terms of market entry and commercialization of NanoTherm(TM) therapy in the USA because we clearly have a "time safety factor" built in our business plan, plus we have accelerated the ambulatory prostate NanoActivator(R) chair development to ensure timely delivery of this device. In Europe, our commercial treatment rate is still too slow but the medical results are very gratifying. The experiences we made from our commercialization efforts over the past 18 months pinpointed how to reach our commercialization targets, and we are enforcing the respective implementation. We are on the right path and overall making progress with our brain cancer Commercialization Program in Europe," commented Dr. Ben J. Lipps, CEO of MagForce AG and MagForce USA, Inc. "In summary, I am very optimistic that MagForce will develop and expand our NanoTherm(TM) therapy into a valued therapy for the treatments of brain cancer and prostate cancer and move towards achieving the goals set in the five year target plan. The growing interest in applying NanoTherm(TM) therapy for the treatment of brain tumors and the progress of our work with the FDA are very encouraging. Thus, we are successfully moving forward on our exciting and challenging path."

Financial Results and Outlook:

Results of operations, net assets and financial position

MagForce adopted new revenue reporting rules for periods starting after December 31, 2015. In addition, MagForce reports for the first time Non- GAAP financial measures that are used by MagForce’s management to make operating decisions, as they facilitate internal comparisons of MagForce’s performance to historical results. MagForce’s management believes that Non- GAAP measures provide investors with means of evaluating, and an understanding of how MagForce’s management evaluates, MagForce’s performance and results on a comparable basis that is not otherwise apparent on a German GAAP basis, since many non-recurring, infrequent or non-cash items that MagForce’s management believes to be not indicative of the core performance of the business may not be excluded when preparing financial measures under German GAAP.

These Non-GAAP measures should not be considered in isolation from, as substitutes for, or superior to financial measures prepared in accordance with German GAAP.

Due to the adoption of new revenue reporting rules (sec. 277 para. 1 HGB as amended by BilRuG) for periods starting after December 31, 2015, revenue includes also management recharges to subsidiaries that were included in other operating income in prior years. For additional information we refer to the Notes to the Interim Financial Statements.

Net loss (prior year: profit) for the first half year was EUR 3.2 million (prior year: EUR 0.5 million) while Non-GAAP net loss slightly decreased for the half year by EUR 0.1 million to EUR 2.2 million (prior year: EUR 2.3 million).

Compared to the prior year reporting period personnel expenses increased by EUR 0.2 million to EUR 1.7 million chiefly due to the formation of a new commercial team to accelerate the Company’s efforts to establish NanoTherm(TM) therapy in Germany and the EU. The additional expenses attached to this indispensable staffing were compensated by frugal use of MagForce’s resources in other areas of controllable expense spending.

Revenues and other operating income amounted to EUR 0.7 milllion (prior year: EUR 4.9 million), while Non-GAAP revenue and other operating income increased by EUR 0.1 million to EUR 0.7 million (prior year: EUR 0.6 million). Revenues and other operating income include revenues from commercial treatment of patients with NanoTherm(TM) therapy on a cash basis as well as reimbursement of treatment costs by third parties and recharges to subsidiaries. The Non-GAAP increase chiefly stems from higher personnel recharges to subsidiaries of EUR 0.4 million compared to EUR 0.3 million in the prior year period.

Revenue and other operating income were adjusted to Non-GAAP for the extension of the distribution and development rights for the countries Canada and Mexico in January 2015 amounting to EUR 3.0 million as well as the sale of two NanoActivator(R) devices to MagForce USA, Inc. in the first half year of 2015 in the amount of EUR 1.2 million. Revenue includes also management recharges to subsidiaries that were included in other operating income in prior years.

Cash outflows from operating activities amounted to EUR -3.4 million (prior year: EUR -3.8 million). Cash inflows from investing activities amounted to EUR 3.1 million (prior year: EUR 0.1 million), and cash flows from financing activities amounted to EUR 2.3 million (prior year: EUR nil).

Liquid funds of the Company including cash and cash equivalents of EUR 3.4 million (December 31, 2015: EUR 1.4 million) as well as short term loans of EUR nil (December 31, 2015: EUR 3.1 million) amounted to EUR 3.4 million at the end of the period (December 31, 2015: EUR 4.5 million).