Spherix Provides Update on Patent Infringement Litigation

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."

Accurexa and StemImmune Collaborate to Develop Stem Cell-mediated Immunotherapy for Cancer

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."

RadioMedix and AREVA Med – SBIR NCI Contract awarded to develop targeted alpha-emitter therapy of neuroendocrine tumors with lead-212.

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."

10-Q – Quarterly report [Sections 13 or 15(d)]

Burzynski Research Institute has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Roche announces CHMP recommendation for EU approval of Venclyxto for people with hard-to-treat chronic lymphocytic leukaemia

On October 14, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto (venetoclax) for the treatment of people with chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation who are unsuitable for or have failed a B-cell receptor pathway inhibitor (Press release, Hoffmann-La Roche , OCT 14, 2016, View Source [SID:SID1234515807]). Venclyxto is also recommended for the treatment of people with CLL without 17p deletion or TP53 mutation who have failed both chemo-immunotherapy and a B-cell receptor pathway inhibitor. Based on this positive CHMP recommendation, a final decision regarding the conditional marketing authorisation of Venclyxto is expected from the European Commission in the coming months. Venclyxto is being co-developed by AbbVie and Roche.

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"We are pleased that this positive CHMP opinion brings us closer to providing a much needed new treatment option to people in Europe with this difficult-to-treat disease," said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. "We look forward to continuing the development of this promising medicine in other blood cancers with our partner AbbVie."

Venclyxto is marketed as Venclexta in the United States. Venclexta received accelerated approval from the US Food and Drug Administration (FDA) in April of this year for the treatment of people with CLL with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy. Venclexta/Venclyxto is the first approved medicine designed to trigger a natural process that helps cells self-destruct, providing a new way to help people who received previous treatment for their CLL or who have a high-risk form of CLL.

About Chronic Lymphocytic Leukaemia (CLL)
CLL is the most common type of leukaemia in the Western world. CLL mainly affects men and the median age at diagnosis is about 70 years. Worldwide, the incidence of all leukaemias is estimated to be over 350,000 and CLL is estimated to affect around one-third of all people newly diagnosed with leukaemia. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of cancerous cells.
In certain cases of CLL, a part of chromosome 17 is lost and along with it an important gene that controls apoptosis (programmed cell death) called p53. The 17p deletion is found in 3 to 10 percent of previously untreated cases and up to 30 to 50 percent of relapsed or refractory cases.

About Venclexta/Venclyxto
Venclexta/Venclyxto is a small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). Overexpression of the BCL-2 protein in chronic lymphocytic leukaemia (CLL) has been associated with resistance to certain therapies. It is believed that blocking BCL-2 may restore the signalling system that tells cells, including cancer cells, to self-destruct. Venclexta/Venclyxto is being co-developed by AbbVie and Roche. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being evaluated in Phase III clinical trials for the treatment of relapsed, refractory and previously untreated CLL, along with studies in several other cancers. Venclexta/Venclyxto is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.