On October 31, 2016 Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported two poster presentations at the 16th Biennial Meeting of the International Gynecologic Cancer Society, held October 29-31 in Lisbon, Portugal (Press release, Mateon Therapeutics, OCT 31, 2016, View Source [SID1234516126]). The poster presentations highlighted previously presented data demonstrating results from the treatment of recurrent ovarian cancer with CA4P, and also provided an overview of Mateon’s Phase 2/3 FOCUS Study evaluating the addition of CA4P to current standard of care in patients with platinum-resistant ovarian cancer.

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Poster Presentations

Improved Progression-Free Survival among Women with Measurable Recurrent Ovarian Carcinoma Treated with CA4P Plus Bevacizumab: A Post-Hoc Analysis of GOG-0186I
FOCUS Study: Physician’s Choice Chemotherapy (PCC) Plus Bevacizumab and CA4P Versus PCC Plus Bevacizumab and Placebo in Platinum-Resistant Ovarian Cancer (prOC)
The first poster presentation highlighted data from post-hoc analyses from the GOG-0186I Study in patients with measurable disease. Study GOG-0186I evaluated the addition of CA4P to treatment with bevacizumab in patients with recurrent ovarian cancer. In the intent-to-treat population, as well as in a subgroup of patients with measurable disease, the addition of CA4P improved progression-free survival (PFS), including improvements in PFS of 6.2 months for patients with larger tumors. The second poster described the design of the company’s on-going FOCUS Study.

"We believe these highly positive data generated for CA4P in combination with anti-angiogenic agents demonstrate the potential for CA4P to alter the treatment landscape for ovarian cancer, and they provide us with confidence as we move our program forward," stated William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "Our clinical investigators are excited to participate in the FOCUS Study, a phase 2/3 trial we initiated in June 2016, and we share their excitement as we look forward to the availability of key data from this study in the second half of 2017."

On October 31, 2016 Deciphera Pharmaceuticals, a clinical-stage biotechnology company focused on developing tumor-targeted and immuno-targeted advanced kinase inhibitors, reported that two abstracts featuring the Company’s clinical-stage tumor-targeted therapies have been selected for a late-breaking oral presentation and a poster discussion at the 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics taking place November 29 to December 2, 2016 in Munich, Germay (Press release, Deciphera Pharmaceuticals, OCT 31, 2016, View Source [SID1234516122]).

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DCC-2618 is a pan-KIT and PDGFR kinase inhibitor in clinical development for the treatment of genetically-defined cancers, including gastrointestinal stromal tumors (GIST) and other KIT-driven cancers such as systemic mastocytosis. Altiratinib is a spectrum selective inhibitor of MET, TRK, TIE2 & VEGFR2 kinases in clinical development for the treatment of solid tumors. DCC-2618 and altiratinib are both currently in Phase 1 first-in-human studies.

"Genetically-defined cancers with specific kinase mutations, such as gastrointestinal stromal tumors and systemic mastocytosis, are ideal targets for our advanced kinase inhibitors and we look forward to sharing clinical data on DCC-2618 and altiratinib at the upcoming EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics," stated Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera Pharmaceuticals.

Late-breaking Oral Presentation:
Title: DCC-2618, a pan KIT and PDGFR switch control inhibitor, achieves proof-of-concept
in a first-in-human study
Author: Janku, F., MD Anderson Cancer Center
Abstract: 7LBA
Session: Plenary Session 6: Proffered Paper Session
Date/Time: Thursday, December 1, 2016, 4:10 p.m. (CET)

Poster Presentation:
Title: The type II switch control kinase inhibitor, DCC-2701 (altiratinib) effectively inhibits
resistant NTRK kinase domain mutants
Author: Drilon, A.
Abstract/Board: 422/P101
Session: Poster Session: Molecular targeted agents II
Date/Time: Thursday, December 1, 2016, 10:15 a.m. – 5:00 p.m. (CET)

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 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 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).