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  • A Promising 2014 For Oncosec ImmunoPulse

    SAN DIEGO, CA, January 14, 2014 - OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy to treat solid tumors, today announced a strategic update and reported on progress made in 2013. Progress included advancing metastatic melanoma, Merkel cell clinical programs and preclinical combination studies with anti-PD-1, anti-PDL-1, and anti-CTLA4, which highlight a commercial path forward.

    "2013 was a landmark year for OncoSec in which we earned recognition in both the scientific and investment communities as a fast-emerging leader in cancer immunotherapy," said Punit Dhillon, OncoSec's president and CEO. "Culminating a year of aggressive clinical development activity, the interim results of our Phase 2 melanoma study underscore the potential of ImmunoPulse to shift the treatment paradigm for patients with metastatic melanoma and generate significant value for stakeholders."

    "Having welcomed our CMO, Robert Pierce, M.D., former Merck Research Labs Executive Director/Member of Global anti-PD-1 Development Team to oversee OncoSec's clinical development studies, we look forward to further advancing our melanoma program this year as we continue to progress and expand our other clinical and preclinical programs. With a solid balance sheet, a promising pipeline and enhanced R&D and manufacturing capabilities, we are entering 2014 well positioned to continue building on the meaningful progress we have made over the last year."

    The following is an overview of key strategic goals for OncoSec's ImmunoPulse program in 2014:

    • Metastatic melanoma Phase 2 study (OMS-I100)
      • Complete enrollment in study being led by the University of California San Francisco (UCSF), University of Washington and other U.S. cancer centers
      • Evaluate dose-intensified treatment schedules
      • Report interim and final analysis of clinical data
      • Initiate Phase 2b metastatic melanoma study
      • Merkel cell carcinoma Phase 2 study (OMS-I110)
        • Complete enrollment in study being led by the University of Washington and UCSF
        • Report clinical data
        • Expand Phase 2 cutaneous T-cell lymphoma study to a multi-institution trial to enhance enrollment and leverage additional expertise in CTCL
        • Initiate additional Phase 1 study in new solid tumor indication

    The following is a summary of milestones achieved in 2013 and additional detail on the company's vision for 2014:

    Metastatic melanoma Phase 2 study (OMS-I100)

    Last December, interim data from OncoSec's ongoing Phase 2 trial in metastatic melanoma confirmed the safety of ImmunoPulse; to date, a total of 47 melanoma patients have been treated without a single serious adverse event. In addition, patients demonstrated positive response rates, reinforcing the encouraging clinical results from the Phase 1 study.

    Importantly, the data also indicated a systemic antitumor immune response in 61.1% of evaluable patients (11/18), as evidenced by objective regression (>30% reduction in size) in at least one untreated lesion. This finding, coupled with the favorable safety data, indicates the potential of ImmunoPulse to deliver systemic benefit, without the toxicities associated with many other systemic treatments.

    Having completed enrollment of 25 patients, OncoSec expects to reach its expanded enrollment target of 30 patients in the near future and report additional data from the trial in mid 2014. As OncoSec prepares to initiate a potential Phase 2b study, the company is also planning to evaluate additional dose-intensified treatment schedules in the current trial and report interim and final analysis later this year.

    Merkel cell carcinoma Phase 2 study (OMS-I110)

    In partnership with leading clinical centers, OncoSec is continuing enrollment in a Phase 2, open-label, single-arm study in Merkel cell carcinoma. OncoSec expects to complete enrollment in this trial in the first quarter and report additional data from the trial in mid 2014.

    Expansion of ImmunoPulse development programs

    Last June, OncoSec entered into a sponsored research agreement with Old Dominion University to evaluate ImmunoPulse in combination with various therapeutic agents, including anti-CTLA4, anti-PD-1, anti-PD-L1 and other immune modulators. As OncoSec continues to investigate ImmunoPulse as monotherapy, this collaboration will enable the company to identify combination approaches that may enhance the efficacy of ImmunoPulse.

    In 2014, OncoSec also expects to expand ImmunoPulse into at least one new solid tumor indication to increase its development pipeline.

    Strategic growth opportunities

    In 2013, OncoSec relocated to a new 6,000 sq. ft. facility where all research and development and general and administrative activities are managed, as well as in-house capabilities to build, maintain and develop its own devices. In 2014, the company expects to enhance manufacturing capabilities for ongoing and future clinical trials, through additional efficiencies and the ability to scale up production as needed to support potential partners.

    Other key areas of growth this year will focus on technical operations, including:

    • Launching new applicator probes for clinical trials
    • Completing working prototype of new OMS Electroporation device
    • Renewing ISO13485 qualification and certification
    • Renewing CE Mark of OncoSec Medical System
    • Completing additional in-licensing opportunities
    • Expanding R&D footprint by acquiring or outsourcing additional lab facilities

    OncoSec plans to hire additional scientists and engineers to support these goals. Next-generation devices and new DNA-based constructs resulting from these efforts are expected to build product value by generating additional intellectual property, both organically and through other in-licensing opportunities.

    Business development

    With a strong balance sheet of $15.2 million as of Q4 2013, OncoSec plans to continue focusing on advancing an aggressive clinical development strategy while maintaining its relatively lean burn rate.

    The company continues to focus on clinical development opportunities, which includes potentially initiating proprietary programs funded by third parties. The company is actively seeking additional grant funding and strategic partnerships to further develop its novel immunotherapy products.

    Dhillon stated, "OncoSec has made great progress in 2013 that has served to validate our clinical efforts and expand our visibility in the scientific community. We look forward to an excellent year ahead and will continue building on our strong fundamentals with the goal of increasing shareholder value, while delivering a meaningful benefit to patients and families impacted by cancer."

    http://oncosec.com/

    By OncoSec
    Jan 16 6:58 PM | Link | Comment!
  • The Long Case For VIASPACE, Inc.

    VIASPACE - Clean Green Energy

    2014 is beginning and investors are looking for new opportunities to maximize their gains in the new year. Here is an exciting company that is under the radar at the moment but has maximum potential for their stock to explode to new heights this year.

    Thesis & Catalyst For VIASPACE, Inc. (OTCQB:VSPC)

    VIASPACE is a multifaceted green energy company. The stock VSPC is undervalued at this time and is expected to breakout this year. VIASPACE grows Giant King Grass as a low-carbon fuel for electricity generating power plants; for energy pellets; and as a feedstock for bio methane production and cellulosic biofuels, biochemicals and biomaterials.

    The company is growing in leaps and bounds. Let me give you a run down on last years accomplishments.

    On October 16, 2012 VIASPACE announced a business agreement with JUNE Industry Ltd. to grow Giant King Grass for commercial applications in Myanmar (formerly known as Burma). Myanmar has a great need for electricity and economic growth. Myanmar has the perfect climate for growing Giant King Grass. Myanmar's recent national reconciliation and economic reforms have placed it on the world stage of business development.

    On January 14, 2013 VIASPACE announced that they had shipped Giant King Grass seedlings from their California nursery to Hawaii and planted them in a quarantine facility there on December 19, 2012 to be grown under the purview of the Hawaii Department of Agriculture. VIASPACE sees tremendous opportunity in the State of Hawaii.

    On January 28, 2013 VIASPACE announced that they had signed a project agreement with Selectra CC of Johannesburg South Africa to grow and examine using Giant King Grass to remediate/restore gold mine affected land through the removal of heavy metals by phytoremediation and by returning organic matter into the mine tailings to make usable soil. Selecta had previously grown sorghum and beets on the mine tailings, but those are annual crops. Giant King Grass is a perennial crop that does not require replanting every year and it also develops an extensive root system to deposit organic matter into the soil. The plan there is to take a major environmental problem and turn it into a major asset by using Giant King Grass for the dual purposes of remediating mine affected soil and then building adjacent biomass power plants to generate electricity from Giant King Grass. On June 6, 2013 they updated the Selectra project in South Africa to report that Giant King Grass was growing well on the mine tailings and the trial project was extended to December 2013. I believe that Giant King Grass is now a leading candidate to be used simultaneously to reclaim gold mine affected lands through the process of phytoremediation and then continuously harvested to create bioelectricity.

    On February 20, 2013 VIASPACE announced our initial contract to grow Giant King Grass with Grain Hill/AGRICORP in Nicaragua, and then on May 21, 2013 VIASPACE announced that VIASPACE and Grain Hill/AGRICORP signed a joint development agreement to build and operate a 12MW power plant co-located with a 2,100 acre Giant King Grass plantation and adjacent rice plantation on irrigated land near Lake Nicaragua. Giant King Grass is growing extremely well in Nicaragua and our partnership with Grain Hill/AGRICORP is progressing nicely. They have a power plant partner, power plant specifications, a full financial model in place and have been meeting with development banks. In this business model, VIASPACE derives revenue both from its Giant King Grass license fee and also from the profits from the sale of electricity.

    On May 30, 2013 VIASPACE announced the signing of a Giant King Grass supply contract with Sagay Central, Inc. of Bacolod City, Negros Occidental, Philippines. Sagay Central, founded in 1945, is a sugar milling and sugar growing company in the center of the Philippines sugar industry and they produce 150,000 tons of sugar per year. Their expertise and experience with growing sugar cane makes them a perfect fit for growing Giant King Grass with a plan for local electricity generation and export to Korea and Japan.

    On July 1, 2013 VIASPACE announced that the Virgin Islands Water and Power Authority (WAPA) Governing Board approved a 25-year Power Purchase Agreement (NYSEARCA:PPA) with Tibbar Energy for the Giant King Grass fueled, 7MW biomass power plant project on St. Croix. The 25-year Power Purchase Agreement is a major milestone and the approved project is the first of its kind in the Caribbean region. This 7MW anaerobic digestion power plant mimics the process in a cow's stomach to produce biomethane which is then used in an engine generator set to produce clean, renewable and carbon-neutral electricity. The byproduct of anaerobic digestion is organic fertilizer which will be put back on the Giant King Grass fields. Our St. Croix project can be duplicated on any tropical island nation desiring a better, less expensive, green energy solution to creating local electricity and farming jobs than using expensive, high carbon output fossil fuels to burn and create electricity.

    On August 6, 2013 VIASPACE expanded their Board of Directors by appointing Mr. Khurram Irshad. Mr. Irshad is founder of Winergy Pakistan (Pvt.) Limited which is developing the world's largest biogas plant based on 500,000 dairy animals at Landhi Cattle Colony in Karachi, Pakistan. Director Irshad has demonstrated biomass business experience, a network of trusted connections, an entrepreneurial nature and he is actively pursuing renewable energy projects in Pakistan, Africa, Asia and here in the U.S.

    Giant King Grass is cut frequently every 45-60 days at 4-5 feet tall, that it is an excellent high protein animal feed very similar in nutritional value to oat hay. On September 24, 2013, VIASPACE announced that the Company had entered into a contract with Maricopa Bio Crops, LLC for a planned first phase 4,500 acre Giant King Grass plantation to produce Giant King Grass hay for cattle feed in Arizona with two additional phases planned. The very first phase project represents estimated profit sharing revenues to VIASPACE of $1.3 million per year and we are planning two additional phases with incremental profit sharing revenues with each phase.

    There are many more projects in the works for VIASPACE - (OTCQB:VSPC) - this in the near future. This is an exciting year for VIASPACE. The momentum is not slowing down and Giant King Grass is growing in leaps and bounds. Now may be an excellent opportunity to invest in this company.

    About VIASPACE Inc.

    VIASPACE grows renewable Giant King™ Grass as a low-carbon fuel for clean electricity generation; for environmentally friendly energy pellets; and as a feedstock for bio-methane production and for green cellulosic biofuels, biochemicals and biomaterials. Giant King Grass is a proprietary, high yield, dedicated biomass clean energy crop. Giant King Grass when it is cut frequently at 4 to 5 feet tall is also excellent animal feed. For more information, please go to www.VIASPACE.com or contact Dr. Jan Vandersande, Director of Communications, at 800-517-8050.

    Forward-Looking Statement Any statements made in this press release which are not historical facts contain certain forward-looking statements; as such term is defined in the Private Security Litigation Reform Act of 1995, concerning potential developments affecting the business, prospects, financial condition and other aspects of the company to which this release pertains. The actual results of the specific items described in this release, and the company's operations generally, may differ materially from what is projected in such forward-looking statements. Although such statements are based upon the best judgments of management of the company as of the date of this release, significant deviations in magnitude, timing and other factors may result from business risks and uncertainties including, without limitation, the company's dependence on third parties, general market and economic conditions, technical factors, the availability of outside capital, receipt of revenues and other factors, many of which are beyond the control of the company. The company disclaims any obligation to update information contained in any forward-looking statement. This press release shall not be deemed a general solicitation.

    Jan 07 11:26 AM | Link | Comment!
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