On October 17, 2016 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that the Company presented additional data regarding VAL-083’s unique anti-cancer mechanism on Saturday October 15, 2016 at the 12th Meeting of the European Association of Neuro-Oncology (EANO) in Mannheim, Germany (Press release, DelMar Pharmaceuticals, OCT 17, 2016, View Source [SID1234515856]).

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DelMar’s poster presentation can be viewed at View Source

"These data further differentiate VAL-083’s mechanism of action against cancer from the current standard of care in the treatment of glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer," said Dr. Dennis Brown, DelMar’s Chief Scientific Officer.

Temozolomide, the current front-line therapy generates its anti-tumor activity by methylation of the O6-position of guanine, resulting in a base-pair mismatch which can be lethal to the tumor cell if not repaired. The majority of patients exhibit a high expression of the DNA repair enzyme "MGMT", which readily repairs temozolomide-derived DNA damage leading to tumor resistance and treatment failure. GBM patients failing temozolomide have a very poor prognosis with median survival of 6 – 9 months.

VAL-083 attacks the tumor’s DNA at a different location and in a different way, rapidly forming durable cross links at the N7-position of guanine. These cross-links are not repaired by MGMT.

"These cross-links result in double-strand breaks during DNA replication which are more potent and more difficult for the cell to repair in comparison to the DNA damage conferred by temozolomide. In particular, MGMT does not act against the type of DNA damage resulting from VAL-083 treatment," added Dr. Brown.

"The EANO meeting provided an opportunity to introduce our VAL-083 to European neuro-oncology thought-leaders," said Jeffrey Bacha chairman & CEO of DelMar. Expanding our relationships with key opinion leaders on a global basis will provide opportunities for collaboration as we expand the development of VAL-083 beyond our current focus in the refractory, Avastin-failed population.

"Importantly, poor patient outcomes due to MGMT-mediated chemo-resistance were a consistent theme throughout the conference. Based on our research, we believe VAL-083’s unique mechanism and ability to circumvent the tumor’s MGMT resistance mechanism may provide a foundational opportunity as a new treatment paradigm," stated Mr. Bacha.

About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.

VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.

The Company has completed a successful end of Phase II meeting with the US FDA and plans to advance VAL-083 into a pivotal clinical trial for GBM patients following bevacizumab failure. DelMar presented data from its Phase I/II clinical trial in refractory GBM at the 2016 American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting demonstrating that the median survival of 22 patients receiving an assumed therapeutic dose of VAL-083 (≥20mg/m2) was 8.35 months following bevacizumab (Avastin) failure compared to published literature where survival of approximately two to five months has been reported.

DelMar’s advanced development program will feature a single multi-center randomized Phase III study measuring survival outcomes compared to a "physicians’ choice" control, which, if successful, would serve as the basis for a New Drug Application (NDA) submission for VAL-083. The control arm will consist of a limited number of salvage chemotherapies currently utilized in the treatment of Avastin-failed GBM. The final pivotal trial design will be confirmed with the FDA following further discussions with the Company’s clinical advisors.

In addition to the pivotal trial, DelMar also plans to initiate two separate Phase II clinical trials in earlier-stage GBM patients.

In collaboration with the University of Texas MD Anderson Cancer Center: A non-comparative, biomarker-driven, Phase II study to determine if treatment of MGMT-unmethylated recurrent GBM with VAL-083 or CCNU improves overall survival at 9 months, compared to historical control in bevacizumab naïve patients. (clinicaltrials.gov identifier: NCT02717962)
In collaboration with Sun-Yat Sen University and Guangxi Wuzhou Pharmaceutical (Group) Co.: A single arm Phase II clinical trial to confirm the tolerability of DelMar’s dosing regimen in combination with radiotherapy (XRT) and to explore the activity of VAL-083 in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high levels of MGMT.
DelMar believes that data from these clinical trials, if successful, will form the basis of a new paradigm in the treatment for all GBM patients who fail, or whose tumors exhibit features that make them unlikely to respond to, currently available chemotherapy.

In addition to its clinical research in GBM, DelMar believes that its research supports a unique mechanism of action for VAL-083 and that these data support the potential of VAL-083 as a new chemotherapy that may offer improved outcomes in the treatment of GBM and other solid tumors in patients whose tumors have failed or exhibit features that make them resistant to or unlikely to respond to current standard-of-care chemotherapy.

On October 17, 2016 Spherix Incorporated (Nasdaq: SPEX) an intellectual property development company committed to the fostering of technology and monetization of intellectual property, reported an update on its active patent infringement lawsuits, new lawsuits filed, and spending reduction initiatives (Press release, Spherix, OCT 17, 2016, View Source [SID1234538994]).

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Anthony Hayes, Chief Executive Officer of Spherix, stated, "Spherix is now in the best position to deliver shareholder value from its patent portfolio than at any time in the past. In the last six months, we’ve effectuated ten new patent infringement lawsuits against defendants with a combined market capitalization of approximately $48 billion. There are more suits on file now than at any time in the last four years. And while most of these suits are recently filed, we are working with our partner Equitable IP to reach fair and equitable settlements with any licensee. Copies of all ten complaints can be viewed on our website, (www.spherix.com). We anticipate additional suits will be filed before year end. I am increasingly encouraged with our strategic position and confident in our ability to create sustainable shareholder value, even as our stock continues to be valued at less than the Company’s net tangible book value."

The following is a list of our key initiatives:

Through our relationship with Equitable IP, we have commenced litigation against:
ATN International, Inc. Commnet Wireless, LLC Choice Communications LLC, and Choice Communications, LLC ("Choice Wireless"), case number: 1:16-cv-00718-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Cincinnati Bell, Inc., case number 1:16-cv-00715-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent, ‘461 patent, and the ‘167 patent.
Echostar Corporation, case number 1:16-cv-00716-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Frontier Communications Corporation, case number 1:16-cv-00714-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Sprint Corporation and Clearwire Corporation case number 1:16-cv-00719-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Fortinet Inc., case number 1:16-cv-00795-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
ViaSat, Inc., case number 1:16-cv-00720-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
DragonWave Inc. and DragonWave Corp, case number 1:16-cv-00797-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Fortinet, Inc, case number 1:16-cv-00795-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
GTT Communications, Inc., case number 1:16-cv-00796-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
The Company’s Federal Circuit appeal against Uniden continues to proceed. The Uniden case has now been fully briefed and oral argument is expected to be calendared in the next several weeks. Oral argument in such appeals is usually calendared within two months of the submission of the Joint Appendix of the record, which was completed on October 5, 2016. The oral argument hearing usually occurs within five to six months of the submission of the Joint Appendix.
Spherix management is confident in its position that the Patent Trial and Appeals Board erred and that the Board’s Decision invalidating Spherix’s patent-in-suit should be reversed. As stated in the briefing, the Board failed to comply with the Administrative Procedure Act and its conclusion is not supported by the evidence. The Board also applied the wrong patent claim construction, requiring a reversal of its obviousness finding. Management looks forward to discussing its position with the Court during the upcoming oral argument and setting the record straight so that this case can move forward.
Mr. Hayes continued, "In addition to the strong progress we have made towards generating revenue, we have taken meaningful steps to reduce overhead and decrease our monthly cash burn. We have delivered sequential reductions in our overhead expenses in each of our last two quarters and expect this trend to continue as we work to refine our cost structure to an appropriate level consistent with providing the company with ample runway to achieving success. With costs on the decline and more than $7 million in unencumbered cash, we have the staying power to drive shareholder value."

"We understand that each of our cases may widely vary with respect to its size, scope and complexity," concluded Mr. Hayes. "However, there is one feature that tends to remain consistent. The patent enforcement process is often long and requires tremendous patience. To that end we want to thank our committed shareholders for their patience and long term focus. Our multimillion dollar settlement with RPX this past May is emblematic of the rewards that we can enjoy from our hard work and dedication simply by staying the course. As we move forward, we are constantly looking for ways to further creating value."

On October 17, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that a review of research conducted with the Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) has been accepted for publication by the prestigious medical journal, Advances in Therapy (Press release, Delcath Systems, OCT 17, 2016, View Source;p=RssLanding&cat=news&id=2212191 [SID1234515872]). The retrospective study, "Chemosaturation Percutaneous Hepatic Perfusion: A Systemic Review," was conducted by a team led by Dr. Arndt Vogel of the University of Hanover in Germany, and resulted from a CHEMOSAT Experts Forum convened by Delcath in February 2015.

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"This retrospective study originated as a white paper produced by our Experts Panel in 2015 as a means of sharing information, recent research results, and clinical experiences using CHEMOSAT to treat primary and metastatic liver cancers," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "We are pleased that Dr. Vogel and his teams’ work has been accepted for publication in such a prestigious journal as Advances in Therapy, and that the potential for CHEMOSAT to treat primary and metastatic liver cancers as identified by our experts will reach a wider audience."

On October 17, 2016 Accurexa Inc. ("Accurexa") (ACXA), a biotechnology company focused on the development of novel neurological therapies to be directly delivered into the brain reported a collaboration with StemImmune Inc. ("StemImmune") to develop its stem cell-mediated immunotherapy for the treatment of cancer, such as brain cancer (Press release, Accurexa, OCT 17, 2016, View Source [SID1234516525]). StemImmune’s immunotherapy uses the stealth anti-cancer payload carrying and tumor seeking capacities of a patient’s own readily available (adult) stem cells to target cancer. The patient’s immune system cannot recognize and react to the "Trojan Horse" stem cells, because they are the patient’s own. To date, StemImmune has treated 25 cancer patients with its proprietary technology in a Phase 1 clinical trial that showed that its stem cell-mediated immunotherapy was safe and well-tolerated with no adverse events reported, and demonstrated potential anti-tumor activity which supports further investigation in clinical trials. All patients received treatment through a minimally invasive outpatient procedure.

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"We are excited to collaborate with StemImmune and to use stem cells for the delivery of immunotherapies. Stem cells have the capacity to home to tumors, and efficiently carry proprietary anti-cancer payloads directly to cancer cells, while mobilizing the patient’s immune system to recognize and fight the cancer. This approach is in line with the mission of Accurexa to directly deliver therapies to targeted areas in the treatment of cancer and other disorders, and adds a clinical-stage oncology program to our pipeline," said George Yu, MD, President & CEO of Accurexa.

"Eradicating cancer and giving patients the ability to undergo lifesaving treatment with no debilitating side effects is what drives our research. Combining our patented technology with Accurexa’s proprietary methods of delivering targeted therapies to specific areas of the brain makes Accurexa a valuable partner for us as we pursue the eradication of cancer," said Aladar Szalay, PhD, Founder, CEO and Chairman of StemImmune. "We look forward to a long and productive relationship with Accurexa."

On October 31, 2016 RadioMedix Inc. and AREVA Med (now Orano Med) reported that they have been awarded a collaborative Small Business Innovation Research Contract by the National Institutes of Health, National Cancer Institute to evaluate targeted alpha-emitter therapy of neuroendocrine tumors (NETs) (Press release, RadioMedix, OCT 16, 2016, View Source [SID1234525018]). This is the fourth NIH funding awarded to RadioMedix during the last three years.

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Targeted Peptide Receptor Radionuclide Therapy (PRRT) of NETs is one of the main clinical focuses of RadioMedix, which has long been involved in several clinical studies as a co-sponsor or a collaborator. AREVA Med is focused on the production of lead-212 (212Pb), a rare metal used in TAT, and the development of therapeutics using this metal.

"We have established a very good collaboration with AREVA Med and we are very pleased that this work resulted in the SBIR Contract," said Izabela Tworowska PhD, Principal Investigator and RadioMedix Chief Science Officer." We have got promising preliminary results and we are confident that this contract will accelerate the development of Targeted Alpha Therapy (TAT) agents. I am grateful to NIH NCI agency for selecting this project for contract funding"

"AREVA Med is very excited about its collaboration with RadioMedix that will further support the growth of our pipeline of 212Pb-labeled agents, especially in NETs where we believe we can bring substantial additional efficacy compared to current treatment options" said Julien Torgue, PhD, AREVA Med Scientific Director.

"We are confident that we have secured all resources needed to accelerate translation of targeted alpha therapy agents to clinic," said Dr. Ebrahim Delpassand, CEO and Chairman of RadioMedix. "Our patients are anxiously waiting for this treatment, and we expect to launch a first in human clinical trial by the end of 2017."