Monday, June 2, 2014

Infinex Ventures Acquires Marijuana Funding, Inc.

DENVER,CO, United States, via eTeligis Inc., 06/02/2014 - - Infinex Venutres, Inc. (OTC Pink: INFX) (PINKSHEETS: INFX) today announced that it has acquired the privately held company Marijuana Funding Inc, www.marijuanafundinginc.com based out of Boulder Colorado. Marijuana Funding, Inc. is a company that specializes in the funding of companies in the burgeoning Medical and Recreational Marijuana Industries. The company works with both conventional and non-traditional loans as well as private equity and possible public offerings. It understands that many of the companies in this industry are saddled with the stigma of an industry that is not accepted yet by the entire mainstream community.

 

"Our goal is to be able to provide a complete solution to our potential clients. The addition of Marijuana Funding to our team allows us to offer to our investors the opportunities to take part in potential private placements or expansions to existing thriving businesses that Infinex can introduce. Our mission is to help these companies meet their goals, whether it be expansion, cost reductions or even mergers, by bringing the missing pieces to the table. By bringing Marijuana Funding in, we can provide aggressive long term financing options for these companies in the terms of real estate acquisitions or refinancing, equipment financing programs, or even the infusion of working capital," said Ron Salem President of Infinex Ventures, Inc.

 

"In addition, it allows us to focus on what we do best which is connecting our investors or partner companies together into synergistic relationships. In this case, we expect to bring alternative delivery systems into the Cannabis Industry, along with setting up more traditional distribution channels in the markets that have legalized these products.", he added. "While we will not have any involvement in the day to day operations of these companies, we will be able to access the incredible profits via joint ventures or other equity plays," he stated.

 

About Infinex Ventures

Infinex Ventures, Inc. is a holding company that specializes in putting companies from different industries together to create more value for each. These synergistic relationships can take the form of mergers, acquisitions or even the finding of equity cash infusions or loans. Our team of consultants work in various fields and can provide support to companies in the areas of accounting, manufacturing, distribution, sales, marketing and other areas of general management. We have worked with a diverse array of clients in fields that include mining, food and beverages, hospitality, event and stage planning and the cannabis industries. We have recently expanded into the cannabis industry through our relationship with Marijuana Funding Inc.

 

www.infxv.com

 

CAUTIONARY STATEMENTS REGARDING FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "believes," "expects," "may," "will," "intends, "plans," "should," "seeks," "pro forma," "anticipates," "estimates," "continues," or other variations thereof (including their use in the negative), or by discussions of strategies, plans or intentions. A number of factors could cause results to differ materially from those anticipated by such forward-looking statements, including those discussed under "Risk Factors" and "Our Business." Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in the forward-looking statements for many reasons.

 

Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, ability to obtain financing and regulatory and shareholder approval for anticipated actions.

 

CONTACT:

Media Relations:
Ron Salem
(802) 566-0707
Email: info@infxv.com
Websites: www.infxv.com
www.marijuanafundinginc.com

 

 

SOURCE: Infinex Ventures, Inc.

 



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Labor SMART, Inc. May 2014 Revenue Tops $2.6 Million

HIRAM, GA, United States, via eTeligis Inc., 06/02/2014 - - Labor SMART, Inc. (OTCQB: LTNC) (the "Company"), an emerging provider of on-demand blue collar staffing primarily in the southeastern United States, today announced it achieved $2,647,061 in revenue for the month of May 2014 (a five week month) an increase of approximately 68 percent over 2013 May revenue of $1,578,503 (also a five week month). For the first five months of 2014, Labor SMART has recorded more than $9 million in revenue, compared to approximately $5.1 million at this point in 2013.

 

"As we expected, we are seeing the ramp up in revenue and business during the warmer weather and what are historically our strongest quarters," said Ryan Schadel, president and CEO of Labor SMART. "While we are very pleased with this revenue increase, we think it is only the beginning of what we expect to be a significant growth in sales in the next several months." Schadel affirmed once again that the company is generating revenue at a rate that enables management to remain comfortable with its projection of $30 million in revenue for 2014.

 

About Labor SMART

Labor SMART, Inc. provides On-Demand temporary labor to a variety of industries. The Company's clients range from small businesses to Fortune 100 companies. Labor SMART was founded to provide reliable, dependable and flexible resources for on-demand personnel to small and large businesses in areas that include construction, manufacturing, hospitality, event-staffing, restoration, warehousing, retailing, disaster relief and cleanup, demolition and landscaping. Labor SMART believes it can make a positive contribution each and every day for the benefit of its clients and temporary employees. The Company's mission is to be the provider of choice to its growing portfolio of customers with a service-focused approach that enables Labor SMART to be seen as a resource and partner to its clients.

 

Safe Harbor Statement 

This release contains statements that constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements appear in a number of places in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of Labor SMART, Inc., its directors or its officers with respect to, among other things: (i) financing plans; (ii) trends affecting its financial condition or results of operations; (iii) growth strategy and operating strategy. The words "may", "would", "will", "expect", "estimate", "can", "believe", "potential", and similar expressions and variations thereof are intended to identify forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond Labor SMART, Inc.'s ability to control, and that actual results may differ materially from those projected in the forward-looking statements as a result of various factors. More information about the potential factors that could affect the business and financial results is and will be included in Labor SMART, Inc.'s filings with the U.S. Securities and Exchange Commission.

 

 

CONTACT: 

 

Beverly Jedynak 

Martin E. Janis & Company, Inc.

312-943-1123 

bjedynak@janispr.com

 

 

SOURCE: Labor SMART, Inc.

 



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Peoplesway.Com, Inc. Moves Ahead on Idea WebCatcher Acquisition

Peoplesway.Com, Inc. (OTC Pink PLWY) (PINKSHEETS: PLWY)

 

Peoplesway is pleased to announce that we have signed a Memorandum of Understanding (MOU) with Idea WebCatcher Holdings, Inc. Under the terms of the MOU, a closing date is scheduled for June 25, 2014. 

 

As previously disclosed, Idea WebCatcher Holdings, Inc. was established to identify and research primarily web- and cloud-based companies, applications and/or projects to incubate and assist operationally. With a number of projects already underway and others in consideration, we are excited about the potential for explosive growth of Idea WebCatcher.

 

"We see tremendous opportunities for multiple revenue streams and ROI for our shareholders through Idea WebCatcher. We believe many of the ideas in development and that are being considered currently could generate $5,000,000 to $10 million or more in revenues each in less than 36 months." Donald Monroe, Chairman.

 

About Peoplesway

Peoplesway.Com, Inc., headquartered in Charlotte, N.C., has historically been an international direct marketing company with an emphasis on its proven proprietary products including products related to the health and wellness industry. It has more recently began targeting companies with high growth potential in the technology sector that can be acquired.

 

Forward Looking Statement

Certain statements contained herein are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve numerous risks and uncertainties, including, but not limited to, risks and uncertainties pertaining to development of Company's products and services and markets for such products and services, the timing and level of customer orders, competitive products and service, changes in economic conditions and other risks and uncertainties. Although the Company believes the statements are reasonable, it can give no assurance that such expectations will prove correct. The Company cautions that any forward-looking statements contained herein are not a guarantee of future performance and that actual results may differ materially.

 

Contact:
Peoplesway.Com, Inc.
Investor Relations
Phone: 888-876-9995
Email: info@mscorpcommunications.com

 

 

SOURCE: Peoplesway.Com, Inc.

 



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Positive Interim Phase IIa ALS Data With BrainStorm's NurOwn Presented at Joint Congress of European Neurology

BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI) today announced that interim results from the Company's Phase IIa ALS trial conducted at Hadassah Medical Center in Jerusalem, Israel were presented yesterday at the Joint Congress of European Neurology by Principal Investigator Professor Dimitrios Karussis. The positive safety and preliminary efficacy results observed in this study are consistent with results observed in the company's previous Phase I/II trial. Between these two studies, a total of 26 patients have been treated with NurOwn™, NEW YORK, NY and PETACH TIKVAH, ISRAEL, United States, via eTeligis Inc., 06/02/2014 - - BrainStorm's stem cell therapy candidate for ALS.

 

Prof. Karussis summarized the results from both phases of the ALS clinical trial, and presented an interim analysis of the data for the first 10 out of 14 patients in the current Phase IIa trial. Results from the last four patients will be analyzed following completion of their six month follow-up period. In all 26 patients who received NurOwn™ in the two trials, no treatment-related serious adverse events were observed. In the three month pre-treatment "run-in" period, 71% of the patients showed progression of disease with decline in neurological function. In contrast, in the three months post-transplantation with NurOwn™, 63% of the patients who received intrathecal (IT), or combined (IT) and intramuscular (IM) administration, showed stabilization or improvement in neurological function, as measured by their revised ALS functional rating score (ALSFRS-R). According to Prof. Karussis, these differences in the preliminary analysis were statistically significant at p=0.035, chi-square test.

 

Additionally, as Prof. Karussis mentioned in his presentation, in both phases of the trial, 63% of the patients treated with NurOwn™ via IT or combined IT and IM administration were defined as "responders" (slower progression of disability or improvement in their neurological function) at 3 months post-treatment, based on both their ALSFRS-R score and Forced Vital Capacity (FVC), an indication of respiratory function. The six patients treated with NurOwn™ in the earlier Phase I/II trial via IM administration only, primarily exhibited a localized positive effect. Similarly, in the same Phase I/II trial, the IT transplanted patients also showed indications of neurotrophic and regenerative effects, as evidenced by an increase in Compound Muscle Action Potential (CMAP) in the treated arm.

 

Prof. Karussis noted, "Administration of NurOwn was well tolerated both intramuscularly and intrathecally. I am very encouraged by signs of disease stabilization and even improvement that we observed in a number of the treated subjects. Analysis of the complete dataset will be invaluable in helping BrainStorm optimize the analysis of its Phase II study, which is about to launch in the United States."

 

"We are very satisfied with the results observed so far in these two studies," commented Chaim Lebovits, BrainStorm's President. "The fact that some of the patients actually demonstrated clinical improvement surpassed our expectations of achieving stabilization or reduced rate of decline. We look forward to the completion of this trial and to building on these results in our double-blind, placebo controlled, multi-center study currently being launched in the USA."

 

About NurOwn
NurOwn is an autologous, adult stem cell therapy technology that differentiates bone marrow-derived mesenchymal stem cells (MSC) into "MSC-NTF" cells. These neuron-supporting cells secrete elevated levels of neurotrophic, or nerve-growth, factors for PROTECTION of existing motor neurons, PROMOTION of motor neuron growth, and RE-ESTABLISHMENT of nerve-muscle interaction. The ability to differentiate mesenchymal stem cells into MSC-NTF cells, and confirmation of their activity and potency before transplantation, makes NurOwn a first-of-its-kind approach for treating neurodegenerative diseases. More information about NurOwn™ can be found at http://brainstorm-cell.com/index.php/science-a-technology/-nurown.

 

About BrainStorm Cell Therapeutics, Inc.
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. For more information, visit the Company's website at www.brainstorm-cell.com.

 

Safe Harbor Statement
Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

 

Contact
BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI)
Mr. Chaim Lebovits
President
Phone: +972-3-9236384
info@brainstorm-cell.com

US Investor Contact
LifeSci Advisors, LLC
Michael Rice
Phone: 646-597-6979
mrice@lifesciadvisors.com

 

 

SOURCE: BrainStorm Cell Therapeutics, Inc.

 



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NewLink Genetics Presents Algenpantucel-L Clinical Data in Poster Discussion Session at ASCO 2014 Annual Meeting

AMES, IA, United States, via eTeligis Inc., 06/02/2014 - - Patient Characteristics for Algenpantucel-L IMPRESS Phase 3 Clinical Study Subjects Consistent With Expectations

 

NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutics to improve treatment options for patients with cancer, today announced additional data with its drug candidate algenpantucel-L that is currently under development for multiple indications in pancreatic cancer.

 

Additional immunological correlative data from the NLG0205 Phase 2 study of adjuvant algenpantucel-L for treatment of resected pancreatic cancer patients was discussed at a poster presentation in Chicago during the 50th Annual meeting of the American Society of Clinical Oncology (ASCO). The NLG0205 Phase 2 clinical study evaluated algenpantucel-L plus standard-of-care adjuvant therapy (gemcitabine and 5-FU based chemoradiotherapy) in 69 patients with resected pancreatic cancer where one year disease-free survival was 62 percent and overall one year survival was 86 percent. Newlink presented data demonstrating that increased anti-calreticulin antibody (anti-CALR Ab) levels following algenpantucel-L treatment correlate with a statistically significant improvement in overall survival. Specifically, the data show median overall survival was 35.8 months in patients with elevated levels of anti-CALR Ab versus 19.2 months in patients without elevated levels(p=0.03).

 

Furthermore, the company presented additional patient demographic data from its ongoing IMPRESS phase 3 pivotal trial. The company evaluated the characteristics of "High Risk vs Low Risk" populations including age, gender, disease, nodal status, CA19-9 levels, resection margin, tumor location and tumor size for all 722 patients enrolled in the IMPRESS study. Specifically, IMPRESS has enrolled a significant majority (92%) of patients with high risk characteristics that were defined as being node positive or having tumor size = 2.5 cm. The patient demographic profile and stage of disease severity were shown to be highly similar across all parameters when compared with the previously reported U.S.-based, multi-center RTOG 9704 clinical study of adjuvant therapy in this patient population, supporting projected survival rates for the control arm of the IMPRESS study.

 

 

"Algenpantucel-L is the most advanced program to emerge through our HyperAcute platform, and we are highly encouraged by this additional data supporting our belief that algenpantucel-L may provide a much needed survival benefit for pancreatic cancer patients," said Charles J. Link, Jr., M.D., Chairman and Chief Executive Officer of NewLink. "We also presented patient population characteristics from our IMPRESS Phase 3 clinical study with algenpantucel-L which were consistent, across the board, with those previously reported in the RTOG 9704 clinical study, supporting our expectations regarding survival rates for patients enrolled in the control arm of the IMPRESS study."

 

"During the last few years, despite some recent reports of novel therapeutic agents showing promise in pancreatic cancer, overall benefits are marginal at best and unfortunately offer only limited survival advantage achieved with significant toxicities," said Dr. Nick Vahanian, President and Chief Medical Officer of NewLink Genetics. He added, "In fact, during the last 3 decades there has been such limited progress made in fighting pancreatic cancer that reports of 1-2 months of survival benefit are still considered significant. We hope our data will shift treatment paradigms by helping to demonstrate the promise of immunotherapy in treating pancreatic cancer patients."

 

These data were presented in a discussed poster presentation entitled "Anti-Calreticulin Antibody Titers Correlate with Improved Overall Survival in a Phase 2 Clinical Trial of Algenpantucel-L Immunotherapy for Patients with Resected Pancreatic Cancer," by NewLink researchers and collaborators at the 2014 Annual Meeting of the American Society of Clinical Oncology (ASCO).

 

Patient enrollment (n=722) is complete in the IMPRESS study (Immunotherapy for Pancreatic Resectable cancer Survival Study). Following completion of the first interim analysis in March of this year, the NewLink Genetics' Independent Data Safety Monitoring Committee (DSMC) reviewed patient data and, as anticipated, recommended study continuation without modification. A second interim analysis is planned upon reaching 333 patient events and, if needed, a final analysis is planned at 444 patient events.

 

About HyperAcute Immunotherapy

NewLink's HyperAcute® immunotherapy platform creates novel biologic products that are designed to stimulate the human immune system to recognize and attack cancer cells. HyperAcute product candidates are composed of human cancer cells that are tumor specific, but not patient specific. These cells have been modified to express alpha-gal, a carbohydrate for which humans have pre-existing immunity. These alpha-gal-modified cells stimulate a rapid and powerful human immune response that trains the body's natural defenses to seek out and destroy cancer cells. The objective of HyperAcute immunotherapies is to elicit an antitumor response by "educating" the immune system to attack a patient's own cancer cells. HyperAcute immunotherapies do not require any tissue from individual patients and use intact whole cells rather than cell fragments or purified proteins. We believe these unique properties of HyperAcute products result in the stimulation of a robust immune response.

 

NewLink's lead product candidate, algenpantucel-L (HyperAcute pancreas), is being studied in a Phase 3 trial (IMPRESS: "Immunotherapy for Pancreatic Resectable cancer Survival Study") under a Special Protocol Assessment with the U.S. Food and Drug Administration. This trial involves up to 722 patients with surgically resected pancreatic cancer. Algenpantucel-L is also being tested in a second Phase 3 study (PILLAR: "Pancreatic Immunotherapy with algenpantucel-L for Locally Advanced non-Resectable"), involving patients with locally advanced pancreatic cancer.

 

NewLink has several HyperAcute product candidates focused on other tumor types in various stages of development, including tergenpumatucel-L, which is in an adaptive design, randomized Phase 2b/3 clinical trial currently accruing up to 240 patients with non-small cell lung cancer.

 

About NewLink Genetics Corporation

NewLink is a biopharmaceutical company focused on discovering, developing and commercializing novel immuno-oncology products to improve treatment options for patients with cancer. NewLink's portfolio includes biologic and small molecule immunotherapy product candidates intended to treat a wide range of oncology indications. NewLink's product candidates are designed to harness multiple components of the immune system to combat cancer without significant incremental toxicity, either as a monotherapy or in combination with other treatment regimens. For more information please visit http://www.linkp.com.

 

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of NewLink that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "target," "potential," "will," "could," "should," "seek," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the prospects and efficacy of algenpantucel-L, tergenpumatucel-L, and our other HyperAcute product candidates and related clinical trials, plans to develop and commercialize our product candidates; ongoing and planned preclinical studies and clinical trials, the timing for completion of enrollment and outcomes of our other ongoing clinical studies; and any other statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that NewLink makes due to a number of important factors, including those risks discussed in "Risk Factors" and elsewhere in NewLink's Annual Report on Form 10-K for the period ended December 31, 2013, Quarterly Report on Form 10-Q for the period ended March 31, 2014, Form S-3 Registration Statement filed December 28, 2012 and in its other filings with the Securities and Exchange Commission. The forward-looking statements in this press release represent NewLink's views as of the date of this press release. NewLink anticipates that subsequent events and developments will cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing NewLink's views as of any date subsequent to the date of this press release.

 

 

CONTACT:

 

Investor Contact:

Gordon Link

Chief Financial Officer

515-598-2925

glink@linkp.com

 

Media Contact:

Gina Nugent

The Yates Network

gina@theyatesnetwork.com

 

 

SOURCE: NewLink Genetics Corporation



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NewLink Genetics Demonstrates Continuing IDO Pathway Inhibitor Progress at ASCO 2014 Annual Meeting

AMES, IA, United States, via eTeligis Inc., 06/02/2014 - - NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutics to improve treatment options for patients with cancer, demonstrated continuing progress with its IDO (indoleamine-(2,3)-dioxygenase) pathway inhibitor program at the American Society for Clinical Oncology (ASCO) 2014 annual meeting. In a series of presentations, NewLink researchers and collaborators presented multiple on-going clinical studies with its IDO pathway inhibitor candidates, expanding the immuno-oncology regimens being evaluated to include combinations with other immunotherapies, cancer vaccines, and chemotherapy. These presentations were highlighted by ASCO as trials in progress posters, demonstrating continued interest for innovative ongoing studies in IDO- mediated checkpoint inhibition.

 

Combination clinical studies presented that highlight NewLink's IDO pathway inhibitor product candidates include:

 

-          Phase 1/2 study of NewLink's most advanced IDO pathway inhibitor, indoximod, in combination with ipilimumab (Yervoy) for unresectable stage 3 or 4 melanoma,

-          Phase 1/2 study of indoximod in combination with temozlomide (Temodar) for primary malignant brain tumors,

-          Phase 2 study of indoximod in combination with docetaxel (Taxotere) in metastatic breast cancer,

-          Phase 2 study of indoximod after sipuleucel-T (Provenge) in metastatic castration-resistant prostate cancer,

-          Phase 1 study of NLG919, the second product candidate from NewLink's IDO pathway inhibitor technology platform, for solid tumors.

 

"We believe NewLink is well positioned to continue to lead in the immune-oncology field as we now have 2 IDO pathway inhibitors from our rich IDO/TDO product pipeline in the clinic and our HyperAcute® platform products are continuing to make progress in the clinic across multiple indications," commented Dr. Nick Vahanian, President and Chief Medical Officer.

 

"With the initiation of these clinical studies we have significantly expanded the immuno-oncology combinations being evaluated with our IDO pathway inhibitor program, representing one of the broadest efforts in the biotech space. We plan to continue our efforts for even further expansion of our IDO program to additional indications by pursuing combination studies with chemotherapies and vaccines or other immune/check point modulators" commented Dr. Charles Link, Chairman and Chief Executive Officer of NewLink. "IDO pathway inhibition has previously demonstrated promising synergies and a good safety profile in preclinical studies in combination with other immunotherapies, cancer vaccines, and chemotherapy and we look forward to reporting on the anti-cancer activity of these combinations as our clinical data mature. We are also beginning to explore the potential of TDO inhibitors as stand-alone therapy and in combination with IDO inhibitors."

 

About inhibition of the IDO pathway

IDO pathway inhibitors are another class of immune check point inhibitors akin to the recently developed antibodies targeting CTLA-4 and PD-1 that represent potential breakthrough approaches to cancer therapy. The IDO pathway regulates immune response by suppressing T-cell activation which enables local tumor immune escape. Recent studies have demonstrated that the IDO pathway is active in many cancers, both within tumor cells as a direct defense against T-cell attack, and also within antigen presenting cells in tumor draining lymph nodes whereby this pathway promotes peripheral tolerance to tumor associated antigens (TAAs). When hijacked by developing cancers in this manner, the IDO pathway may facilitate the survival, growth, invasion and metastasis of malignant cells whose expression of TAAs might otherwise be recognized and attacked by the immune system. NewLink has a number of active programs directed at synthesizing inhibitors to the IDO pathway and additionally has discovered novel tryptophan-2,3-dioxygenase (TDO) specific inhibitors that are potential anti-cancer compounds which could function individually or in combination with IDO inhibition.

 

About NewLink Genetics Corporation

NewLink is a biopharmaceutical company focused on discovering, developing and commercializing novel immuno-oncology products to improve treatment options for patients with cancer. NewLink's portfolio includes biologic and small molecule immunotherapy product candidates intended to treat a wide range of oncology indications. NewLink's product candidates are designed to harness multiple components of the immune system to combat cancer without significant incremental toxicity, either as a monotherapy or in combination with other treatment regimens. For more information please visit http://www.linkp.com.

 

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of NewLink that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "target," "potential," "will," "could," "should," "seek," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the prospects and efficacy of indoximod, NLG919, and our other IDO pathway product candidates and related clinical trials, plans to develop and commercialize our product candidates; ongoing and planned preclinical studies and clinical trials, the timing for completion of enrollment and outcomes of our other ongoing clinical studies; and any other statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that NewLink makes due to a number of important factors, including those risks discussed in "Risk Factors" and elsewhere in NewLink's Annual Report on Form 10-K for the period ended December 31, 2013, Quarterly Report on Form 10-Q for the period ended March 31, 2014, Form S-3 Registration Statement filed December 28, 2012 and in its other filings with the Securities and Exchange Commission. The forward-looking statements in this press release represent NewLink's views as of the date of this press release. NewLink anticipates that subsequent events and developments will cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing NewLink's views as of any date subsequent to the date of this press release.

 

* Yervoy is a registered trademark of Bristol-Meyers Squibb

* Temodar is a registered trademark of Merck & Co.

* Taxovere is a registered trademark of Sanofi-Aventis

* Provenge is a registered trademark of Dendreon Corporation

* Gemzar is a registered trademark of Eli Lily and Co.

* Abraxane is a registered trademark of Celgene Corporation

 

 

CONTACT:

 

Investor Contact:

Gordon Link

Chief Financial Officer

515-598-2925

glink@linkp.com

 

Media Contact:

Gina Nugent

The Yates Network

gina@theyatesnetwork.com

 

SOURCE: NewLink Genetics Corporation

 



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PetVivo Holdings, Inc. and Gel-Del Technologies, Inc. Sign Binding Term Sheet to Merge

MINNEAPOLIS, MN, United States, via eTeligis Inc., 06/02/2014 - - PetVivo Holdings, Inc. (OTCQB: PETV) announced today it has entered into a binding term sheet for a merger with Gel-Del Technologies, Inc. Under the agreed upon terms Gel-Del will merge with PetVivo Holdings, Inc. and upon resolution of certain conditions specified as terms, a definitive agreement will consummate the merger.

 

Gel-Del Technologies CEO Dr. David Masters stated, "I am excited to see our companies join forces to facilitate the commercialization of our innovative medical devices in both the veterinary and clinical markets. This merger also allows our shareholders to be rewarded for their patience."

 

"This is a great opportunity for both Gel-Del and PetVivo. Gel-Del can benefit from PetVivo's access to capital and short-term product revenues," noted PetVivo CEO John Lai. "In addition, PetVivo will also gains access to Gel-Del's full range of devices and drug delivery products while also improving margins."

 

"The pending merger of these two companies provides a tremendous boost to the intellectual property position of PetVivo Holdings, Inc.," explained John F. Dolan, General Counsel of PetVivo. "Gel-Del has an extensive patent portfolio including approximately thirty-five patents and patent applications filed in the United States and internationally, as well as having well documents trade secrets that protect the various products and processes PetVivo intends to commercialize. The merger of the companies has the potential to exponentially increase PetVivo's proprietary position in the veterinary and human medical device markets."

 

Details of the merger have been filed by PetVivo Holdings with the Securities and Exchange Commission and can be found on Edgar.

 

About Gel-Del Technologies, Inc:

Gel-Del Technologies (www.gel-del.com) is a biomaterial and medical device manufacturing company based in St. Paul, Minnesota. The Company has completed a licensing agreement with PetVivo Holdings, Inc. (OTCQB: PETV) to commercialize its veterinary medical devices for the treatment of osteoarthritis. The Company has also successfully completed a pivotal clinical trial using their novel thermoplastic biomaterial as a dermal filler for human cosmetic applications (clinicaltrials.gov NCT00414544).

 

Gel-Del's core competencies are developing and manufacturing medical devices containing its proprietary thermoplastic protein-based biomaterials that mimic the body's tissue to allow integration, tissue repair, and regeneration for long-term implantation. These biomaterials are produced using a patented and scalable self-assembly production process. The inherent thermoplastic properties of these biomaterials are then utilized to manufacture or coat implantable devices.

 

About PetVivo Holdings, Inc.: 

PetVivo, Inc. is a wholly owned subsidiary of PetVivo Holdings, Inc. (OTCQB: PETV) based in Minneapolis, Minnesota. PetVivo is an emerging biomedical device company focused on the licensing and commercialization of innovative medical devices and other therapeutics for pets.

PetVivo, Inc. believes that it can leverage the investments in the human bio-materials and medical device industries to commercialize therapeutics to pets in a capital and time efficient way. PetVivo's strategy is to in-license proprietary products from human medical device companies specifically for use in pets. A key component of this strategy is the accelerated timeline to revenues for veterinary medical devices, which enter the market much earlier than the more stringently regulated pharmaceuticals.

 

The fore-going material may contain forward-looking statements. We caution that such statements may be subject to uncertainties and that actual results could differ materially from the forward-looking statements. Readers accordingly should not place undue reliance on these forward-looking statements, which do not reflect unknown or unanticipated events or circumstances occurring after the date of these forward-looking statements.

 

 

CONTACT: 

 

Gel-Del Technologies:

David B. Masters, Ph.D.

Chief Executive Officer 

Gel-Del Technologies, Inc.

Email: web@gel-del.com 

Phone: 651-209-0707
 

PetVivo: 

John Lai 

Chief Executive Officer 

PetVivo Holdings, Inc. 

Email: info@petvivo.com 

Phone: 612-296-7305

 

 

SOURCE: PetVivo Holdings, Inc.

 



Associated Documentation:


Link to submission on http://www.eteligis.com
PETV_6-2-2014_PAP_ETL.docx

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