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ImmuneRegen BioSciences(R) Enters Into a Sponsored Research Agreement With the University of Pittsburgh
Pitt Scientist Ted M. Ross, Ph.D., to Explore the Use of Viprovex(R) as an Adjuvant to Novel Influenza Vaccines
May 14, 2009 8:00:00 AM
Email Story Discuss on ZenoBank
View Additional ProfilesSCOTTSDALE, AZ -- (MARKET WIRE) -- 05/14/09 -- ImmuneRegen BioSciences®, a wholly owned subsidiary of IR Biosciences Holdings Inc. (OTCBB: IRBS), today announced it has entered into a sponsored research agreement with Ted M. Ross, Ph.D., an assistant professor at the University of Pittsburgh's Center for Vaccine Research. Dr. Ross, a respected leader in his field, will explore the use of ImmuneRegen's lead influenza therapeutic product, Viprovex®, as an adjuvant to novel influenza vaccines.
Dr. Ross is renowned for his research and development of effective vaccines for influenza, HIV-1, and emerging infectious diseases. He has extensive experience in evaluating immune response characteristics in preclinical models for various influenza and HIV vaccines, including virus-like particle (VLP)-based vaccines, and he has established animal models to assess both cellular and humoral immune responses to antigens. His most recent publications have evaluated the efficacy of an H5N1 VLP-based vaccine.
Viprovex, a derivative of Homspera, already is being developed for potential use against infectious diseases as a stand-alone or combination therapy and as a vaccine adjuvant.
In studies of influenza-infected animals performed at other research facilities, ImmuneRegen's Viprovex® has consistently demonstrated efficacy in reducing symptoms related to seasonal (e.g. H1N1 and H3N2) influenza and highly-pathogenic (e.g. H5N1) influenza strains. The current pandemic "Swine Flu" (H1N1) has many attributes of typical seasonal influenza strains.
Previous studies, also performed at other research facilities, revealed Viprovex used as a vaccine adjuvant increased concentrations in blood of antibodies against both the virus used for vaccination as well as cross-reactive antibodies against different influenza strains, a desired effect as the virus components in influenza vaccines often do not exactly match the influenza viruses causing illness.
About ImmuneRegen BioSciences Inc.
ImmuneRegen BioSciences Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB: IRBS), is a development-stage biotechnology company focused on the research, development and licensing of Homspera® and its derivatives. Homspera is an adult stem cell active compound that in study results has been shown to regenerate and strengthen the immune system and enhance wound healing. Viprovex, a derivative of Homspera, is being developed for potential use against infectious diseases as a stand-alone or combination therapy and as a vaccine adjuvant. To advance its mission, the Scottsdale, Arizona-based company has forged numerous study partnerships with industry and academic leaders, including Celgene Cellular Therapeutics, HemoGenix, Lovelace Respiratory Research Institute, Virion Systems, University of Rochester and University of Pittsburgh. For more information, please visit www.immuneregen.com.
Statements about ImmuneRegen's future expectations, including statements about the potential use and scientific results for ImmuneRegen's drug candidates, science and technology, and all other statements in this press release other than historical facts, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. ImmuneRegen intends that such forward-looking statements be subject to the safe harbors created thereby. These future events may not occur as and when expected, if at all, and, together with ImmuneRegen's business, are subject to various risks and uncertainties. ImmuneRegen's actual results could differ materially from expected results as a result of a number of factors, including the uncertainties inherent in research and development collaborations, pre-clinical and clinical trials and product development programs (including, but not limited to the fact that future results or research and development efforts may prove less encouraging than current results or cause side effects not observed in current pre-clinical trials), the evaluation of potential opportunities, the level of corporate expenditures and monies available for further studies, capital market conditions, and others set forth in ImmuneRegen's periodic report on Form 10-KSB for the year ended December 31, 2008 as filed with the Securities and Exchange Commission. There are no guarantees that any of ImmuneRegen's proposed products will prove to be commercially successful. ImmuneRegen undertakes no duty to update forward-looking statements.
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Contact:
John Fermanis
ImmuneRegen BioSciences Inc.
Phone: 480-922-3926
E-mail: Email Contact
ImmuneRegen(R) Licenses Intellectual Property From University of Pittsburgh to Further Develop Proprietary Compound
Apr 30, 2009 8:00:00 AM
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View Additional ProfilesSCOTTSDALE, AZ -- (MARKET WIRE) -- 04/30/09 -- ImmuneRegen BioSciences®, a wholly owned subsidiary of IR Biosciences Holdings Inc. (OTCBB: IRBS), is pleased to announce that recent studies utilizing Homspera® confirm the compound stimulates a broad and long-lasting immune response in animals, as well as, provides protection against intracellular pathogens.
Specifically, the active component of Homspera, an agonist of the neurokinin-1 receptor (NK1R), among other immunostimulatory activities, promotes the activation and migration of skin dendritic cells (DCs) to lymph nodes to induce functional antigen specific cellular immunity, including CD4+ T-helper 1 cells (Th1) and CD8+ cytotoxic T-lymphocyte (CTL) responses. In addition, the NK1R agonist promotes the survival of DCs in vitro and in vivo resulting in prolonged effector immune responses. Together the adjuvant effects of the NK1R agonists are highly desired for effective immunization approaches. These studies were performed in the laboratories of Dr. Adriana Larregina, M.D., Ph.D., research assistant professor in the departments of Dermatology and Immunology, University of Pittsburgh School of Medicine.
ImmuneRegen and the University have negotiated a license agreement that supports ImmuneRegen's vaccine development program. In this license, ImmuneRegen obtains rights to use Dr. Larregina's research data as well as a license to the University's ownership interest in a patent recently filed by ImmuneRegen in support of Homspera's intellectual property portfolio.
ImmuneRegen is developing Homspera, the NK1R-specific analog of the endogenous neuropeptide Substance P (SP), as a potential vaccine adjuvant. Initial studies by ImmuneRegen have revealed adjuvant activity for Homspera with influenza virus vaccines, resulting in greater antibody responses and corresponding protection from challenges with related viruses. Follow-up studies evaluating different treatment routes and a number of experimental vaccines have confirmed this adjuvant effect of Homspera.
"Substance P has been reported to activate the innate immune system and has been hypothesized to have many roles in the body," said Hal Siegel, Ph.D., ImmuneRegen Vice President and Chief Scientific Officer. "Previous studies of Homspera have shown increased antibody responses to both influenza vaccination and model antigens, but these are the first detailed studies to demonstrate this adjuvant activity extends to aspects of cellular immunity."
About ImmuneRegen BioSciences Inc.
ImmuneRegen BioSciences Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB: IRBS), is a development-stage biotechnology company focused on the research, development and licensing of Homspera and its derivatives. Homspera is an adult stem cell active compound that in study results has been shown to regenerate and strengthen the immune system and enhance wound healing. Viprovex®, a derivative of Homspera, is being developed for potential use against infectious diseases as a stand-alone or combination therapy and as a vaccine adjuvant. To advance its mission, the Scottsdale, Arizona-based company has forged numerous study partnerships with industry and academic leaders, including Celgene Cellular Therapeutics, HemoGenix, Lovelace Respiratory Research Institute and Virion Systems. For more information, please visit www.immuneregen.com.
Statements about ImmuneRegen's future expectations, including statements about the potential use and scientific results for ImmuneRegen's drug candidates, science and technology, and all other statements in this press release other than historical facts, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. ImmuneRegen intends that such forward-looking statements be subject to the safe harbors created thereby. These future events may not occur as and when expected, if at all, and, together with ImmuneRegen's business, are subject to various risks and uncertainties. ImmuneRegen's actual results could differ materially from expected results as a result of a number of factors, including the uncertainties inherent in research and development collaborations, pre-clinical and clinical trials and product development programs (including, but not limited to the fact that future results or research and development efforts may prove less encouraging than current results or cause side effects not observed in current pre-clinical trials), the evaluation of potential opportunities, the level of corporate expenditures and monies available for further studies, capital market conditions, and others set forth in ImmuneRegen's periodic report on Form 10-KSB for the year ended December 31, 2008 as filed with the Securities and Exchange Commission. There are no guarantees that any of ImmuneRegen's proposed products will prove to be commercially successful. ImmuneRegen undertakes no duty to update forward-looking statements.
Contact:
John Fermanis
ImmuneRegen BioSciences Inc.
Phone: 480-922-3926
E-mail: Email Contact
LETTER FROM THE CEO
April 8, 2008
Dear Shareholder,
We are pleased to report that ImmuneRegen has successfully completed one of the three triggering milestones defined in Section 17 of the Form of Debenture between IR BioSciences Holdings, Inc. and YA Global Investments, L.P.
Results of a preclinical study on our synthetic peptide, Viprovex®, by the United Kingdom’s Health Protection Agency, Centre for Emergency Preparedness and Response, indicate efficacy in reducing the severity of H5N1 (avian flu). The findings suggest the possibility that Viprovex enhances the immune system’s response to the influenza virus.
The Health Protection Agency’s “H5N1 Avian Influenza Virus: Ferret Study” found that all Viprovex-treated animals were more active than their corresponding controls throughout the nine-day study period, and exhibited less weight loss and hypothermia. None of the animals treated with Viprovex showed the degenerative neurological symptoms of neck stiffness, hind-limb paralysis, diarrhea or labored breathing typical of the disease as seen in the untreated animals.
Previous animal and cell culture studies have shown Viprovex, a derivative of ImmuneRegen’s adult stem cell-active compound Homspera™, to have an impact on the activation of components of the innate immune system. A major cause of flu-related deaths is the exaggerated response of the immune system to the rapidly multiplying virus, and this influenza study suggests Viprovex has potential in dampening the pathology associated with the resulting immune response. While no significant difference was found in the virus levels in nose, lung and brain between test and control animals, extracts from the spleen of test animals that received the antiviral drug Viprovex intranasally exhibited a lower concentration of the virus than extracts from the corresponding controls.
The results from this study strengthen our confidence that Viprovex may provide treatment applications against a potential influenza pandemic. I’m sure you share my enthusiasm about these study results that are important steps in ImmuneRegen’s goal to become a key player in this high-opportunity arena.
Michael K. Wilhelm
Chief Executive Officer
http://www.sec.gov/Archives/edgar/data/793043/000118518508000268/ex99-1.htm
IRBO IR BIOSCIENCES 8-K filed today
IRBO is a NEW YA Global client.
http://www.sec.gov/Archives/edgar/data/793043/000118518508000017/irbio-8k01092007.htm
"up to $3 million of secured convertible debentures" with YA Global Investments L.P.
Will IRBO be one of the YA Global clients experiencing a strong surge in PPS within an 8-week period after their first financing with YA Global?
See iBox:
http://investorshub.advfn.com/boards/board.asp?board_id=9964
jonesie
Distant1a, I am expecting FDA approval possibly as soon as within a month's time.
Hey Doc! What's your take on this move? Is this the for runner of a hostile take over?
Well Doc I suppect you might want to distant yourself from MDFY. This thing sure has the appearance of going under but, for me, there is no point in selling. I'd rather not loose 80 g but will live without it!
Thanks, distant1a. I am on a mission to collect stocks badly beaten up and near bottom in supersubpenny range, with the appropriate share structure and impending news on increasing shareholder value, in order to pick up 300-400%+ gains like recently happened with IMJX to take profits off the table and simultaneously ride on free shares for more profit taking without holding out all the shares for what some will say is the BIGGER prize by refusing to sell any along the way!
If you know of any at or near $0.0001 you are investing and with significant potential, let me know. I would like to check them out!
I hope so! Anyway, good luck on your other endeavors!!!!
Big upside is anticipated. The ball is in the CEO's court.
IRBO, now at $0.29, up 38.10% today!
From their Form 8-K of 10/10/06:
ITEM 1.01. ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT.
The information in Item 3.02, below, is incorporated herein by reference.
ITEM 3.02 UNREGISTERED SALES OF EQUITY SECURITIES.
On October 4, 2006, IR Biosciences Holdings, Inc. (the "Company") effected an
initial closing of a private placement, whereby the Company sold an aggregate of
$2,276,500 worth of units ("Units") to accredited investors as defined by Rule
501 under the Securities Act of 1933, as amended (the transaction is referred to
herein as the "Private Placement").
Pursuant to the terms of the subscription agreement, each Unit was sold for
$25,000 and consisted of (i) 156,250 shares of common stock of the Company, par
value $0.001 per share (the "Common Stock"); and (ii) a warrant to purchase, at
any time prior to the fifth anniversary following the final closing of the
Private Placement, 78,125 shares of Common Stock at an exercise price of $0.50
per share. A total of 14,228,125 shares and 7,114,063 warrants were sold to
investors at the initial closing of the Private Placement. The Company agreed to
file a registration statement, covering the securities sold in the Private
Placement, not before 180 days after the final closing of the Private Placement
and not later than 190 days after the final closing of the Private Placement.
The shares and warrants were offered and sold to investors in reliance upon
exemptions from registration pursuant to Section 4(2) under the Securities Act
of 1933, as amended, and Rule 506 promulgated thereunder. In addition, the
Company may elect to redeem the warrants (but not less than all the warrants),
upon certain conditions and after providing at least thirty-days written notice
to warrant holders.
In connection with the Private Placement, the Company issued an additional
2,276,500 shares of Common Stock to the placement agent or its designees, upon
the initial closing of the Private Placement. The shares were issued as
consideration for the placement agent's services in connection with the Private
Placement. The shares were issued in reliance upon exemptions from registration
pursuant to Section 4(2) under the Securities Act of 1933, as amended, and Rule
506 promulgated thereunder. In addition, the placement agent received $349,776
in commission and expenses as compensation for its services.
THIS CURRENT REPORT IS NOT AN OFFER OF SECURITIES FOR SALE. ANY SECURITIES SOLD
IN THE PRIVATE PLACEMENT WILL NOT HAVE BEEN REGISTERED UNDER THE SECURITIES ACT
OF 1933, AS AMENDED, AND MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES UNLESS
REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR PURSUANT TO AN
EXEMPTION FROM SUCH REGISTRATION.
Copyright © 2006 QuoteMedia. All rights reserved. Terms of Use.
Market Data powered by QuoteMedia, www.quotemedia.com, SEC filings by 10kWizard.
About ImmuneRegen BioSciences, Inc.
IR BioSciences Holdings Inc., through its wholly owned subsidiary ImmuneRegen BioSciences, Inc., is developing Homspera™ and its derivatives Radilex™ and Viprovex™ as a family of countermeasures for multiple homeland security threats, including chemical agents, Acute Radiation Sickness (ARS) from a dirty bomb or nuclear disaster, and infectious disease/biological warfare scenarios. This positions the base compound Homspera as a potential Universal Protectant. Homspera is derived from modified homeostatic Substance P, a naturally occurring neuropeptide immunomodulator and homeostatic compound with the dual effect of improving pulmonary function and the stimulation of the human immune system. Further advances with the Office of Naval Research (ONR) and the U.S. Air Force are currently being pursued.
The development of Homspera and its derivatives is pursuant to the U.S. Food and Drug Administration's "animal efficacy" rule, which allows an expedited development and approval process. In addition, these compounds are candidates for the Strategic National Stockpile under current BioShield law.
http://www.immuneregen.com/press49-defense.php
Welcome aboard, Tom. .I think you more you read about this one, the more interesting it becomes.
Good question. From what I have heard up until this point, it could be as early as this current year. Realize that the urgency of having available an effective treatment for pulmonary anthrax, among others, as a matter of public urgency in the event of a widespread attack, could result in such a product being "fast tracked" and not having to go through the usual timely hoops to receive FDA approval.
Further investigation is needed here. I have only just begun to look into it, took an "initial" bite on this with a nice position in the event we are looking at a 10-bagger from here on FDA approval alone. This stock was recommended to me by a very reliable source, someone closely tied to homeland security.
Very funny, dwudman!
(Need a little levity right about now, haha!)
BTW, our friendship is etched in stone!
Doc, I haven't researched yet...so what stage are they in...I/II/or III? Seems that they would have to be in stage III if FDA approval is "not far off".
How can a legitimate Doctor have this much time to moderate and post on message boards???
Are you Dr. Freud?
(to anyone reading this, it is a private joke between myself and verylong...so please don't read anything into it other than a ribbing between friends)
Hey Doc,
Tjak(Tom) here from MDFY. I will read up on this, it seems interesting. Have a nice day.
I have a question, nothing to do about either MDFY or IRBO, but how this website works! If one wants or needs to speak privately with going public, how does someone go about it. Nothing sinister or earth shaking here. Just want to know if I have need to do so in future!
First message. Started this board and came on board with this stock because of the huge potential in treating pulmonary anthrax and other agents from biologic warfare.
$0.22 seemed like a very good entry point to me.
Check this one out. I do appreciate very much being directed to this stock. To the best of my understanding, FDA approval for one of the drugs may not be too far off!
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IR BioSciences Holdings Inc., through its wholly owned subsidiary ImmuneRegen BioSciences, Inc., is developing Homspera™ and its derivatives Radilex™ and Viprovex™ as a family of countermeasures for multiple homeland security threats, including chemical agents, Acute Radiation Sickness (ARS) from a dirty bomb or nuclear disaster, and infectious disease/biological warfare scenarios. This positions the base compound Homspera as a potential Universal Protectant. Homspera is derived from modified homeostatic Substance P, a naturally occurring neuropeptide immunomodulator and homeostatic compound with the dual effect of improving pulmonary function and the stimulation of the human immune system. Further advances with the Office of Naval Research (ONR) and the U.S. Air Force are currently being pursued.
Press Release Source: ImmuneRegen BioSciences, Inc.
ImmuneRegen Announces Further Results From Anthrax Treatment Study
Thursday August 17, 7:00 am ET
Hyperion Biotechnology, Inc. and ImmuneRegen Continue Testing the Effects of Viprovex(TM) for Possible Use to Treat the Effects of Anthrax Exposure
SCOTTSDALE, Ariz., Aug. 17 /PRNewswire-FirstCall/ -- ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTC Bulletin Board: IRBO - News), today announced further results from pre-clinical tests of Viprovex(TM) for possible use to treat the effects of pulmonary anthrax infection. ImmuneRegen is collaborating with Hyperion Biotechnology Inc. to perform these tests at Hyperion's research facility located on the United States Air Force School of Aerospace Medicine (USAFSAM) campus in Brooks City-Base, Texas.
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Initial studies in a well-established mouse model system indicate a potential positive effect in the use of Viprovex to both prophylactically and therapeutically treat the effects of a near lethal anthrax-exposure. Animals exposed to near lethal doses of anthrax spores were treated with Viprovex either before anthrax exposure or afterwards and test results indicated a survival rate ranging from 20% to 70% of control animals that otherwise would likely have died. In vitro studies confirm elevation of multiple classes of immunomodulators in response to Viprovex, and management believes these results add further support to continued efforts towards additional testing of Viprovex. "The company is optimistic in its development of the compound for this unmet medical need," says a company spokesperson.
Studies utilizing a formulation of the same active ingredient, Homspera(TM), in an animal model of lethal radiation exposure, show increased survival and immune system reconstitution, lending credence to the hypothesis that Homspera may be of value in a number of biodefense applications.
About Viprovex
Viprovex is the trade name used in referring to formulations of Homspera for potential indications for treatment of maladies caused by exposure to various chemical and biological agents. Homspera is a generic name used by the Company to describe the synthetic peptide Sar9, Met (O2)11-Substance P. Sar9, Met (O2)11-Substance P is an analog of the naturally occurring human neuropeptide Substance P, which can be found throughout the body, including in the airways of humans and many other species. All of the Company's research and development efforts are early, pre-clinical stage and both Homspera and Viprovex have only undergone exploratory studies to evaluate their biological activity in small animals.
About Hyperion
Hyperion Biotechnology was founded in 1998 and has active programs in the area of biomarker discovery, wound healing, performance enhancement, infectious disease treatment and other homeland security related topics. These research efforts have been funded by contracts with the Department of Defense (DoD).
The development of Homspera and its derivatives is pursuant to the U.S. Food and Drug Administration's "animal efficacy" rule, which allows an expedited development and approval process. In addition, these compounds are candidates for the Strategic National Stockpile under current BioShield law.
The majority of our current development efforts are aimed at developing two possible therapeutic applications for Homspera: Radilex and Viprovex. Radilex is being developed as a formulation of Homspera intended to treat acute radiation exposure. Viprovex is being developed for the treatment of maladies caused by exposure to chemical and biological weapons agents.
ImmuneRegen BioSciences is currently pursuing FDA approval for Radilex and Viprovex, but both are still experimental drug candidates, and are not yet approved for human use.
For more information, please visit the company's website at http://www.immuneregen.com/.
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