Drugs and Pharmaceuticals

SELECT TRIAL used Selenomethionine Instead of High-Selenium Yeast, SelenoExcell(R)

Author: Cypress Systems, Inc.
Dateline: Wed, 29 Oct 2008

freeNewsArticles Story Summary: “FRESNO, Calif., Oct. 29 (SEND2PRESS NEWSWIRE) -- Cypress Systems, Inc, a Fresno CA based biotechnology company, emphasizes that the SELECT TRIAL results - that were announced yesterday - used a form of selenium known as selenomethionine. The SELECT TRIAL found no effects of either selenomethionine or vitamin E on the incidence of prostate cancer. See Related Website at cypsystems.com.”



A R T I C L E:

Previous Research has shown SelenoExcell(R) Supplementation to reduce Lung, Colon and Prostate Cancers by as much as 63%

FRESNO, Calif., Oct. 29 (SEND2PRESS NEWSWIRE) -- Cypress Systems, Inc, a Fresno CA based biotechnology company, emphasizes that the SELECT TRIAL results - that were announced yesterday - used a form of selenium known as selenomethionine. The SELECT TRIAL found no effects of either selenomethionine or vitamin E on the incidence of prostate cancer. See Related Website at www.cypsystems.com .

The results of the SELECT TRIAL are consistent with previous animal studies. For example, Dr. David McCormick at the Experimental Toxicology and Carcinogenesis Division, IIT Research Institute in Chicago found no effects with selenomethionine supplementation on the prevention of prostate cancer in rats (Eur Urol 1999;35:464-467).

Such negative findings have not been observed for other forms of selenium. For example, research at Purdue University found SelenoExcell(R) High-Selenium Yeast to be more effective than selenomethionine in the reducing DNA damage in canine prostate cells (Waters et al, J. Natl Cancer Inst (2003); 95:237-240). Researchers at the University of Arizona and Cornell University reported in the Journal of American Medical Association (Clark et al, JAMA, Dec. 25, 1996-vol. 276, No.24).) that regular use of 200 micrograms per day of selenium in the form of SelenoExcell(R) reduced the incidences of lung, colon, and prostate cancers by 50-63%. Researchers at the Penn State University Cancer Institute found that supplementation with SelenoExcell(R), reduced serum PSA levels, a risk indicator for prostate cancer (El-Bayoumy et al, Cancer Epidemiology Vol. 11, 1459-1465, Nov., 2002). References to these and other studies can be found at the website, www.cypsystems.com - under the research matrix "Cancer" section of the home page.

Paul A. Willis, CEO & President of Cypress Systems, Inc. stated that "Clearly we believe that the SELECT TRIAL should have included the standardized high-selenium yeast, which has been found effective in reducing cancer risk in animal studies and human clinical trials." High-selenium yeast is different from selenomethionine. It contains several different forms of organically-bound selenium in addition to selenomethionine.

According to Dr. Mark Whitacre, Cypress Systems' COO, "We suspect that the advantage of SelenoExcell(R) High-Selenium Yeast lies in its content of multiple forms of selenium, including some that are more direct acting in anti-carcinogenesis."

All trademarks are property of their respective owners.

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Copyright © 2008 by Cypress Systems, Inc. and Send2Press® Newswire, a service of Neotrope® - all rights reserved. Information believed accurate but not guaranteed. Sourced on: freeNewsArticles.com.

Story Title: SELECT TRIAL used Selenomethionine Instead of High-Selenium Yeast, SelenoExcell(R)
• REFERENCE KEYWORDS/TERMS: Cypress Systems SelenoExcell, , , high-selenium yeast, Drugs and Pharmaceuticals, , , .

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Drugs and Pharmaceuticals

Targeting Metastatic Cancer from the Inside: Epeius Biotech Reveals a New Generation of Tools for Medical Gene Delivery

Author: Epeius Biotechnologies Corporation
Dateline: Mon, 06 Oct 2008

freeNewsArticles Story Summary: “SAN MARINO, Calif., Oct. 6 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation today announced the publication of another landmark paper describing recent technological advances in medical gene delivery. The latest scientific paper, entitled 'Targeting metastatic cancer from the inside: A new generation of targeted gene delivery vectors enables personalized cancer vaccination in situ,' was published in the October issue of the International Journal of Oncology.”



A R T I C L E:

SAN MARINO, Calif., Oct. 6 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation today announced the publication of another landmark paper describing recent technological advances in medical gene delivery. The latest scientific paper, entitled "Targeting metastatic cancer from the inside: A new generation of targeted gene delivery vectors enables personalized cancer vaccination in situ," was published in the October issue of the International Journal of Oncology (IJO). The paper describes the new state-of-the-art in tumor-targeting biotechnology, nanotechnology, and therapeutic gene delivery developed for clinical applications in the field of oncology. The paper lays the scientific, preclinical and clinical foundations for new applications of personalized medicine, specifically for patients with metastatic cancer.

EpeiusBased on recent breakthroughs in pathotropic (or disease-seeking) tumor targeting technologies, a new generation of anti-cancer agents is currently being developed. Anti-cancer agents such as Rexin-G can be delivered by simple intravenous infusion, yet are designed to seek out and accumulate in primary and metastatic lesions that have spread throughout the body. Rexin-G is essentially a pathotropically targeted nanoparticle of genetic medicine that is guided by a proprietary targeting technology and is designed to deliver a killer-gene selectively to tumor cells and their associated (proliferative) blood supply.

Representing the first and so far only targeted genetic medicine proven to be both safe and effective in the clinic, Rexin-G is commercially available in the Philippines -- for use in all solid tumors that are refractory to standard chemotherapy -- and is currently in clinical trials in the USA for several cancer indications.

Following the validation of its lead product in the clinic, Epeius Biotech has developed a second tumor-targeted anti-cancer agent, named Reximmune-C, designed to work in concert with Rexin-G by providing a localized cancer vaccination aimed at gaining additional tumor control.

According to Dr. Erlinda M. Gordon, Medical Director of Epeius Biotech, "Based on the clear survival benefits of Rexin-G that we are seeing in our clinical trials, we felt obligated to advance this new product to provide an opportunity for personalized cancer vaccination in patients who may still be at risk for recurrence."

Reximmune-C is a tumor-targeted gene delivery vector delivering an immune-stimulating cytokine gene directly to residual tumors, with the intent of generating a localized vaccination to encourage a lasting anti-tumor immunity. The IJO paper summarizes the preclinical studies, pilot clinical studies, and the elegant vector design engineering embodied in Reximmune-C, which make this clinical application possible.

About Epeius Biotechnologies

Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its proprietary targeted delivery systems. To learn more about our pipeline of proprietary biotechnologies currently available for clinical development and/or new product development, please visit us at www.epeiusbiotech.com.

For more information about Rexin-G, Reximmune-C, on-going clinical trials in the USA and abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.

All trademarks acknowledged.


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Copyright © 2008 by Epeius Biotechnologies Corporation and Send2Press® Newswire, a service of Neotrope® - all rights reserved. Information believed accurate but not guaranteed. Sourced on: freeNewsArticles.com.

Story Title: Targeting Metastatic Cancer from the Inside: Epeius Biotech Reveals a New Generation of Tools for Medical Gene Delivery
• REFERENCE KEYWORDS/TERMS: Epeius Biotechnologies Corporation, , , pathotropic biopharmaceuticals, Drugs and Pharmaceuticals, , , .

IMPORTANT NOTICE: some content which is considered "old" or "archival" may reference an event which has already occurred; some content possibly considered "advertorial" may also reference a promotion or time-limited/sensitive offering, and in all of these instances certain material may no longer be valid. For notably stale content, you should directly contact the company/person mentioned in the text (Epeius Biotechnologies Corporation); this site cannot assist you with information about products/services mentioned in the news article, nor handle any complaints or other issues related to any person/company mentioned or promoted in the above text. Information believed accurate but not guaranteed as of original date of story [Mon, 06 Oct 2008 12:14:50 GMT].

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Drugs and Pharmaceuticals

Epeius Biotechnologies’ Lead Product, Rexin-G for Metastatic Cancer, Aptly Highlighted by National Cancer Institute Journal

Author: Epeius Biotechnologies Corporation
Dateline: Mon, 15 Sep 2008

freeNewsArticles Story Summary: “SAN MARINO, Calif., Sept. 15 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation today announced that Rexin-G, its lead product in development for metastatic cancer, has been highlighted in a recent NEWS article published by the Journal of the National Cancer Institute (JNCI, Sept. 9, 2008). The article, authored by Vickie Brower, describes recent advances and new approaches in genetic medicine that may succeed where small molecules and proteins have failed.”



A R T I C L E:

SAN MARINO, Calif., Sept. 15 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation today announced that Rexin-G, its lead product in development for metastatic cancer, has been highlighted in a recent NEWS article published by the Journal of the National Cancer Institute (JNCI, Sept. 9, 2008). The article, authored by Vickie Brower, describes recent advances and new approaches in genetic medicine that may succeed where small molecules and proteins have failed. Noted for its recent demonstrations of safety and single-agent efficacy in several types of metastatic cancers that were refractory to standard chemotherapy, Rexin-G is described as the world's second commercially approved gene therapy-while it remains the first and so far only targeted, injectable genetic medicine that has been effectively validated in the clinic.

EPEIUSRexin-G, with its elegant tumor-targeting biotechnologies, performs a vital surveillance function for the benefit of the cancer patient: distributing throughout the general circulation, while constantly seeking-out and accumulating in primary tumors and metastatic tissues that have spread throughout the body. Within minutes, the tumor-targeted nanoparticles of Rexin-G begin to accumulate within the cancerous lesions to high levels, delivering a lethal payload of genetic medicine selectively to cancer cells and their attendant blood supply, while sparing normal cells and tissues.

In a series of four clinical trials that are currently ongoing in the United States, Rexin-G has demonstrated dose-dependent improvements in tumor-control indices, while exhibiting no dose-limiting toxicities. The JNCI article noted that Rexin-G has been granted Orphan Drug Status by the U.S. FDA for three different types of cancers: osteosarcoma, soft-tissue sarcoma, and pancreatic cancer. Ten months ago, Rexin-G was formally approved in the Philippines for the treatment of all solid tumors that are refractory to standard chemotherapies.

The JNCI NEWS article also highlighted the second tumor-targeted agent in development by Epeius Biotechnologies, describing Reximmune-C as an immune stimulant, or personalized cancer vaccine, designed to be used alone or in combination with Rexin-G. Reximmune-C incorporates a powerful cytokine gene, in place of the cytocidal gene used in Rexin-G, to deliver an immune-stimulating pulse to activate a patient's own immune cells in the area of residual tumors to prevent recurrence. Remarkably, several of the prominent cancer researchers, companies, and academicians interviewed for the JNCI article focused-in principle-on the very same issues that Epeius Biotechnologies, with its definitive molecular engineering platform, has actually managed to address. The JNCI article is well worth reading.

About Epeius Biotechnologies

Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its proprietary targeted delivery systems. To learn more about our pipeline of proprietary biotechnologies that are currently available for licensing and clinical development, please visit our website, www.epeiusbiotech.com.

For more information about Rexin-G, Reximmune-C, and on-going clinical trials in the USA and abroad, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.

All trademarks acknowledged.


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Copyright © 2008 by Epeius Biotechnologies Corporation and Send2Press® Newswire, a service of Neotrope® - all rights reserved. Information believed accurate but not guaranteed. Sourced on: freeNewsArticles.com.

Story Title: Epeius Biotechnologies' Lead Product, Rexin-G for Metastatic Cancer, Aptly Highlighted by National Cancer Institute Journal
• REFERENCE KEYWORDS/TERMS: Epeius Biotechnologies, , , metastatic cancer drugs, Drugs and Pharmaceuticals, , , .

IMPORTANT NOTICE: some content which is considered "old" or "archival" may reference an event which has already occurred; some content possibly considered "advertorial" may also reference a promotion or time-limited/sensitive offering, and in all of these instances certain material may no longer be valid. For notably stale content, you should directly contact the company/person mentioned in the text (Epeius Biotechnologies Corporation); this site cannot assist you with information about products/services mentioned in the news article, nor handle any complaints or other issues related to any person/company mentioned or promoted in the above text. Information believed accurate but not guaranteed as of original date of story [Mon, 15 Sep 2008 11:06:58 GMT].

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Drugs and Pharmaceuticals

Epeius Biotechnologies’ Tumor-Targeted Rexin-G Receives FDA Orphan Drug Designation for The Treatment of Osteosarcoma

Author: Epeius Biotechnologies Corporation
Dateline: Tue, 08 Jul 2008

freeNewsArticles Story Summary: “SAN MARINO, Calif., July 8 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation today announced that Rexin-G has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Based on several criteria, including the rarity, seriousness, and current lack of effective therapies for metastatic osteosarcoma, as well as the scientific and medicinal merit of Rexin-G, the granting of Orphan Drug Status by the FDA validates the unique clinical development strategy.”



A R T I C L E:

SAN MARINO, Calif., July 8 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation today announced that Rexin-G has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Based on several criteria, including the rarity, seriousness, and current lack of effective therapies for metastatic osteosarcoma, as well as the scientific and medicinal merit of Rexin-G, the granting of Orphan Drug Status by the FDA validates the unique clinical development strategy of Epeius Biotechnologies: that is, to demonstrate the profound single-agent efficacy of Rexin-G where traditional treatments have historically failed.

EpeiusThe FDA Orphan Drug Act was designed to encourage the development of new products that demonstrate significant promise for the treatment of very serious or life-threatening conditions that are relatively rare, affecting fewer than 200,000 persons in the United States. Orphan Drug Designation provides important economic incentives and powerful market protections that encourage the development of innovative products in the cancer field. U.S. Orphan Drug Designation provides seven years of market exclusivity for Rexin-G, a reduction in fees and taxes, and additional regulatory support for R&D initiatives.

About Rexin-G
Rexin-G(R), the lead product of Epeius Biotechnologies, is the first in a series of tumor-targeted anti-cancer agents designed to seek out and accumulate in metastatic cancers that have spread throughout the body, delivering a lethal payload of genetic medicine to tumor cells and their associated blood supplies without harming normal cells, tissues, or organ systems. Specifically designed to function within the context of the human circulatory system, the demonstration of single agent-efficacy by Rexin-G in Stage IV or metastatic osteosarcoma (ASCO, 2008) is an indication of the remarkable clinical potential of the precision targeting technologies embodied in its design. The Orphan Drug designation by the FDA represents an important milestone in the clinical development of Rexin-G for osteosarcoma.

About Epeius Biotechnologies
Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its proprietary targeted delivery systems. Credited with innovations ranging from gene discovery, designer therapeutics, pathotropic (disease-seeking) targeting, vector engineering, to advanced biopharmaceutical manufacturing and bioprocess development, Epeius Biotechnologies is well positioned to "launch" its enabling platform biotechnologies for the benefit of cancer patients worldwide.

To learn more about our pipeline of proprietary biotechnologies that are currently available for licensing and clinical development, please visit us at www.epeiusbiotech.com.


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Copyright © 2008 by Epeius Biotechnologies Corporation and Send2Press® Newswire, a service of Neotrope® - all rights reserved. Information believed accurate but not guaranteed. Sourced on: freeNewsArticles.com.

Story Title: Epeius Biotechnologies' Tumor-Targeted Rexin-G Receives FDA Orphan Drug Designation for The Treatment of Osteosarcoma
• REFERENCE KEYWORDS/TERMS: FDA Orphan Drug Designation, , , Epeius Biotechnologies Rexin-G, Drugs and Pharmaceuticals, , , .

IMPORTANT NOTICE: some content which is considered "old" or "archival" may reference an event which has already occurred; some content possibly considered "advertorial" may also reference a promotion or time-limited/sensitive offering, and in all of these instances certain material may no longer be valid. For notably stale content, you should directly contact the company/person mentioned in the text (Epeius Biotechnologies Corporation); this site cannot assist you with information about products/services mentioned in the news article, nor handle any complaints or other issues related to any person/company mentioned or promoted in the above text. Information believed accurate but not guaranteed as of original date of story [Tue, 08 Jul 2008 14:42:48 GMT].

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Drugs and Pharmaceuticals

Phase I/II Study of Targeted Gene Delivery In Vivo – Intravenous Infusions of REXIN-G

Author: Epeius Biotechnologies Corporation
Dateline: Thu, 29 May 2008

freeNewsArticles Story Summary: “SAN MARINO, Calif., May 29 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies announced today the results of an on-going Phase I/II study of Rexin-G for metastatic bone and soft tissue sarcoma (J Clin Oncol 26: 14509, 2008). Rexin-G is the first and so far only targeted gene therapy vector that has been tested in the clinic (Nature Reviews/Genetics 2007).”



A R T I C L E:

Intravenous Infusions of REXIN-G - Demonstrates Dose-Dependent Anti-Tumor Activity Without Toxicity in Patients with Progressive Chemo-Resistant Bone and Soft Tissue Sarcoma (ASCO 2008)

SAN MARINO, Calif., May 29 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies (www.epeiusbiotech.com) announced today the results of an on-going Phase I/II study of Rexin-G for metastatic bone and soft tissue sarcoma (J Clin Oncol 26: 14509, 2008). Rexin-G is the first and so far only targeted gene therapy vector that has been tested in the clinic (Nature Reviews/Genetics 2007).

Caption: Rexin-G clinical trialIn this open label study, cohorts of 6 to 7 patients with all types of sarcoma, including osteosarcoma, Ewing's sarcoma, leiomyosarcoma, malignant fibrous histiocytoma, chondrosarcoma, fibrosarcoma, liposarcoma, angiosarcoma, spindle cell sarcoma, and malignant mixed Mullerian tumor of ovary, were treated with 1 x 10e11 cfu Rexin-G, administered i.v. over 5 minutes, 2 times a week for 4 weeks (Cumulative Dose = 8 x 10e11 cfu) followed by a 2-week rest period. Patients with Grade 1 or less toxicity were given progressive intra-patient dose-escalations consisting of additional treatment cycles of 1 to 2 x 10e11 cfu three times a week for 4 weeks (Cumulative Dose per cycle: 1.2-2.4 x 10e12 cfu).

These higher dosing regimens were associated with prolonged disease stabilization and a median overall survival of greater than 6 months, which was three times longer than that observed in the low-dose group. Further, histologic examination of resected tumors showed 50-90% necrosis. No dose-limiting toxicity was observed, even at the higher doses of Rexin-G, thus confirming that repeated infusions of Rexin-G are safe and well-tolerated.

Taken together with previous clinical studies conducted in the Philippines and Japan, these studies confirm the exemplary safety and dose-dependent efficacy of Rexin-G in a broad spectrum of chemotherapy-resistant cancers.

For more information about Rexin-G, on-going clinical trials in the USA and abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.


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Copyright © 2008 by Epeius Biotechnologies Corporation and Send2Press® Newswire, a service of Neotrope® - all rights reserved. Information believed accurate but not guaranteed. Sourced on: freeNewsArticles.com.

Story Title: Phase I/II Study of Targeted Gene Delivery In Vivo - Intravenous Infusions of REXIN-G
• REFERENCE KEYWORDS/TERMS: pharma clinical trials, , , Epeius Biotechnologies Corporation, Drugs and Pharmaceuticals, , , .

IMPORTANT NOTICE: some content which is considered "old" or "archival" may reference an event which has already occurred; some content possibly considered "advertorial" may also reference a promotion or time-limited/sensitive offering, and in all of these instances certain material may no longer be valid. For notably stale content, you should directly contact the company/person mentioned in the text (Epeius Biotechnologies Corporation); this site cannot assist you with information about products/services mentioned in the news article, nor handle any complaints or other issues related to any person/company mentioned or promoted in the above text. Information believed accurate but not guaranteed as of original date of story [Thu, 29 May 2008 13:19:21 GMT].

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Drugs and Pharmaceuticals

CYNACON / OCuSOFT(R) Announces OCuSOFT(R) Lid Scrub(TM) PLUS Now Available in CVS Pharmacies

Author: OCuSOFT, Inc.
Dateline: Wed, 28 May 2008

freeNewsArticles Story Summary: “RICHMOND, Texas (SEND2PRESS NEWSWIRE) -- CYNACON / OCuSOFT(R) (OCuSOFT(R), Inc.), a company specializing in ophthalmic research, development and supply to ophthalmologists and optometrists, is pleased to announce that as a convenience to all patients, OCuSOFT(R) Lid Scrub(TM) Plus is now available in CVS pharmacies, nationwide.”



A R T I C L E:

RICHMOND, Texas, May 28 (SEND2PRESS NEWSWIRE) -- CYNACON / OCuSOFT(R) (OCuSOFT(R), Inc.), a company specializing in ophthalmic research, development and supply to ophthalmologists and optometrists, is pleased to announce that as a convenience to all patients, OCuSOFT(R) Lid Scrub(TM) Plus is now available in CVS pharmacies, nationwide.

Caption: OCuSOFT Lid Scrub PLUSOCuSOFT(R), Inc., recognized as the market leader, recently introduced OCuSOFT(R) Lid Scrub(TM) PLUS for moderate to severe eyelid conditions where bacterial involvement is suspected.

OCuSOFT(R) Lid Scrub(TM) PLUS is strongly recommended by physicians as a pre-surgical prep or as an adjunct therapy for blepharitis and dry eye conditions.

In an independent laboratory study, the anti-bacterial effectiveness of OCuSOFT(R) Lid Scrub(TM) Plus demonstrated a 99 percent kill rate for bacteria that included, but was not limited to: S. epidermidis, E.coli, P. aeriginosa, M. catarrhalis, S. marcescens as well as methicillin-resistant S. aureus (MRSA).

OCuSOFT(R) Lid Scrub(TM) PLUS has been formulated with a moisturizing agent that allows the patient to leave it on. This "Leave on Formula" ensures prolonged contact and maximizes the bacterial time kill rate without rinsing.

"Even though patients can now purchase the product at CVS, as a convenience, doctors may still make OCuSOFT(R) Lid Scrub(TM) PLUS available to patients in their office," Troy Smith, Vice President of Sales for OCuSOFT(R) Inc, says. "Special discounts ensure that patients can purchase OCuSOFT(R) Lid Scrub(TM) PLUS from their doctor's office at prices comparable to that of retail drug stores."

OCuSOFT(R) Lid Scrub(TM) PLUS is packaged in convenient pre-moistened pads and is also available in an instant foam pump dispenser. Accordingly, this formula soothes, relieves irritation, and removes contaminants from the eyelids.

OCuSOFT(R), Inc. is dedicated to addressing clinical needs with novel technological solutions that optimize the delivery and performance of ophthalmic pharmaceutical products, which in turn improve patient care and compliance.

For a free sample of OCuSOFT(R) Lid Scrub(TM) PLUS, click: www.ocusoft.com/sample1.html.

For more information about the company and their products, visit: www.ocusoft.com.

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Copyright © 2008 by OCuSOFT, Inc. and Send2Press® Newswire, a service of Neotrope® - all rights reserved. Information believed accurate but not guaranteed. Sourced on: freeNewsArticles.com.

Story Title: CYNACON / OCuSOFT(R) Announces OCuSOFT(R) Lid Scrub(TM) PLUS Now Available in CVS Pharmacies
• REFERENCE KEYWORDS/TERMS: OCuSOFT Lid Scrub PLUS, , , ophthalmic pharmaceutical products, Drugs and Pharmaceuticals, , , .

IMPORTANT NOTICE: some content which is considered "old" or "archival" may reference an event which has already occurred; some content possibly considered "advertorial" may also reference a promotion or time-limited/sensitive offering, and in all of these instances certain material may no longer be valid. For notably stale content, you should directly contact the company/person mentioned in the text (OCuSOFT, Inc.); this site cannot assist you with information about products/services mentioned in the news article, nor handle any complaints or other issues related to any person/company mentioned or promoted in the above text. Information believed accurate but not guaranteed as of original date of story [Wed, 28 May 2008 01:05:25 GMT].

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Drugs and Pharmaceuticals

Targeted Gene Delivery Signals Cancer Vaccination in Vivo

Author: Epeius Biotechnologies Corporation
Dateline: Tue, 27 May 2008

freeNewsArticles Story Summary: “SAN MARINO, Calif., May 27 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies announced today that the results of a Phase I Feasibility Study of sequential targeted gene delivery-using Rexin-G followed by Reximmune-C-for cancer vaccination will be presented at the ASCO meetings in Chicago on June 1, 2008 (J Clin Oncol 26:3077, 2008). Rexin-G and Reximmune-C are pathotropic (disease-seeking) nanoparticles bearing a cytocidal cyclin G1 gene and a granulocyte-macrophage colony stimulating factor (GM-CSF) gene, respectively.”



A R T I C L E:

Intravenous Infusions of Rexin-G Followed by Reximmune-C Induce Tumor Necrosis and Recruitment of Tumor Infiltrating Lymphocytes in Cancerous Lesions (ASCO 2008)

SAN MARINO, Calif., May 27 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies (www.epeiusbiotech.com) announced today that the results of a Phase I Feasibility Study of sequential targeted gene delivery-using Rexin-G followed by Reximmune-C-for cancer vaccination will be presented at the ASCO meetings in Chicago on June 1, 2008 (J Clin Oncol 26:3077, 2008). Rexin-G and Reximmune-C are pathotropic (disease-seeking) nanoparticles bearing a cytocidal cyclin G1 gene and a granulocyte-macrophage colony stimulating factor (GM-CSF) gene, respectively. When injected intravenously, these targeted vectors seek out and accumulate in cancerous lesions, thus increasing the effective local concentrations of the therapeutic nanoparticles within the tumors.

Caption: EpeiusThe working hypothesis behind this two-stage approach to cancer management predicts that strategic and individualized vaccination of a patient against his/her own cancer can be achieved by combining (1) the targeted vector bearing a potent cytocidal construct, Rexin-G, with (2) a targeted vector bearing an immune activating gene, Reximmune-C. Rexin-G is given first to kill the cancer cells and thus expose neoantigens within the tumors, followed by Reximmune-C to recruit the body's immune cells into the same tumor compartments, thereby prompting recognition of the tumor neoantigens in situ and inducing long-lasting anti-tumor immunity.

The purpose of the Phase I study was to evaluate the over-all safety/toxicity and therapeutic potential of this sequential regimen, in an effort to achieve a personalized cancer vaccination in vivo. Seven patients with chemo-resistant cancer, including carcinoma of breast, colon and pancreas, non-small cell lung cancer and leiomyosarcoma, received Rexin-G i.v. at a dose of 4 x 10e10 cfu per day for 2 to 6 weeks (Cumulative Dose: 4.0 x 10e11 to 1.2 x 10e12 cfu) followed by Reximmune-C i.v. at 2.5 x 10e9 cfu for 5 days or 5 x 10e9 cfu for 2 days (Cumulative Dose: 1.00 -1.25 x 10e10 cfu).

Analysis of Safety showed that no dose-limiting toxicity was observed with this regimen, and immunoreactive GM-CSF protein was NOT detected in serum samples either during or after treatment with Reximmune-C. There was no significant alteration in hemodynamic function, bone marrow suppression, liver, kidney, or any other organ dysfunction related to the intervention. Immune-related reactions consisted of transient flu-like symptoms in two patients, redness and swelling of a tumor-infiltrated lymph node and one metastatic chest nodule, and acute flank pain in one patient with adrenal gland metastasis.

Analysis of efficacy in biopsied tumor specimens revealed definitive expression of the GM-CSF transgene in cancer cells indicating effective gene delivery in vivo. Further, extensive tumor necrosis and tumor infiltrating lymphocytes (TILs) were observed within the tumors. Characterization of the recruited TILs showed CD35+ dendritic cells, CD8+ killer T cells, and CD138+ plasma B cells, with lesser amounts of CD68+ macrophages and CD20+ B cells, suggesting a relatively mature or advanced immune response.

Taken together, this landmark study demonstrates (1) that the functionality of the gene delivery platform is profound; (2) the genetic constructs employed are relatively safe; and (3) the potential for a personalized cancer vaccination using this sequential gene transfer approach is now a realistic goal.

For more information about Rexin-G, Reximmune-C, on-going clinical trials in the USA and abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.


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Copyright © 2008 by Epeius Biotechnologies Corporation and Send2Press® Newswire, a service of Neotrope® - all rights reserved. Information believed accurate but not guaranteed. Sourced on: freeNewsArticles.com.

Story Title: Targeted Gene Delivery Signals Cancer Vaccination in Vivo
• REFERENCE KEYWORDS/TERMS: cancer management, , , Epeius Biotechnologies Rexin-G, Drugs and Pharmaceuticals, , , .

IMPORTANT NOTICE: some content which is considered "old" or "archival" may reference an event which has already occurred; some content possibly considered "advertorial" may also reference a promotion or time-limited/sensitive offering, and in all of these instances certain material may no longer be valid. For notably stale content, you should directly contact the company/person mentioned in the text (Epeius Biotechnologies Corporation); this site cannot assist you with information about products/services mentioned in the news article, nor handle any complaints or other issues related to any person/company mentioned or promoted in the above text. Information believed accurate but not guaranteed as of original date of story [Tue, 27 May 2008 11:40:00 GMT].

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Drugs and Pharmaceuticals

TARGETED GENE DELIVERY IN VIVO: Rexin-G Monotherapy Reveals Significant Biological Activity without Toxicity in Chemo-Resistant Metastatic Breast Cancer (ASCO 2008)

Author: Epeius Biotechnologies Corporation
Dateline: Thu, 22 May 2008

freeNewsArticles Story Summary: “SAN MARINO, Calif., May 22 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies announced today the promising results of an on-going United States-based Phase I/II study of Rexin-G for metastatic breast cancer that is refractory to conventional chemotherapy (J Clin Oncol 26:14509, 2008). This clinical trial employed intra-patient dose-escalations of Rexin-G given i.v. two to three times a week for 4 weeks, with doses ranging from 2 x 10e11 cfu to 6 x 10e11 cfu per week.”



A R T I C L E:

SAN MARINO, Calif., May 22 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies announced today the promising results of an on-going United States-based Phase I/II study of Rexin-G(R) for metastatic breast cancer that is refractory to conventional chemotherapy (J Clin Oncol 26:14509, 2008). This clinical trial employed intra-patient dose-escalations of Rexin-G given i.v. two to three times a week for 4 weeks, with doses ranging from 2 x 10e11 cfu to 6 x 10e11 cfu per week. The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II pivotal study.

Caption: Rexin-G cancer clinical trialThe interim results of this Phase I/II study of targeted gene delivery in vivo are very encouraging-intravenous infusions of Rexin-G demonstrated significant biological activity without toxicity in patients with rapidly progressive chemo-resistant breast cancer. Once the general safety of repeated infusions of Rexin-G was documented, the FDA approved across the board intra-patient dose-escalations in order to gain better tumor control.

These escalating doses of Rexin-G were associated with stabilization of disease, using both RECIST and International PET criteria, significant reductions in CA 15.3 levels, a median progression-free survival of 6 months (RECIST) and a median over-all survival of greater than 7 months with all patients surviving at the 8-month follow-up period. No dose-limiting toxicity was observed, even at the higher doses of Rexin-G, thus confirming that repeated infusions of Rexin-G are safe and well-tolerated.

According to Dr. Erlinda M. Gordon, Medical Director of Epeius, "The importance of these dose-escalation studies-which clearly establish safety before escalating to more potent tumoricidal levels-is a primary concern in the development of a new genetic medicine like Rexin-G."

Taken together with the results of previous studies, the current on-going Phase I/II study confirms the exemplary safety and therapeutic potential of Rexin-G in chemotherapy-resistant metastatic breast cancer.

For more information about Rexin-G, on-going clinical trials in the USA and abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.

Epeius Biotechnologies: www.epeiusbiotech.com.

Rexin-G is a reg. trademark.


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Copyright © 2008 by Epeius Biotechnologies Corporation and Send2Press® Newswire, a service of Neotrope® - all rights reserved. Information believed accurate but not guaranteed. Sourced on: freeNewsArticles.com.

Story Title: TARGETED GENE DELIVERY IN VIVO: Rexin-G Monotherapy Reveals Significant Biological Activity without Toxicity in Chemo-Resistant Metastatic Breast Cancer (ASCO 2008)
• REFERENCE KEYWORDS/TERMS: pharma gene delivery systems, , , Epeius Biotechnologies Corporation, Drugs and Pharmaceuticals, , , .

IMPORTANT NOTICE: some content which is considered "old" or "archival" may reference an event which has already occurred; some content possibly considered "advertorial" may also reference a promotion or time-limited/sensitive offering, and in all of these instances certain material may no longer be valid. For notably stale content, you should directly contact the company/person mentioned in the text (Epeius Biotechnologies Corporation); this site cannot assist you with information about products/services mentioned in the news article, nor handle any complaints or other issues related to any person/company mentioned or promoted in the above text. Information believed accurate but not guaranteed as of original date of story [Thu, 22 May 2008 12:46:02 GMT].

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Drugs and Pharmaceuticals

ASCO 2008: Tumor-Targeted Rexin-G Demonstrates Dose-Dependent Anti-Tumor Activity without Toxicity in Metastatic Pancreatic Cancer

Author: Epeius Biotechnologies Corporation
Dateline: Mon, 19 May 2008

freeNewsArticles Story Summary: “SAN MARINO, Calif., May 19 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies announced today the results of an on-going Phase I/II study of Rexin-G for metastatic pancreatic cancer (Chawla et al., ASCO meeting, 2008). Continuing on with the planned dose-escalations of Rexin-G which began in 2005 using lower doses of Rexin-G in a Phase I safety study (Molecular Therapy, 2008), the current Phase I/II study employed higher dose-escalations of Rexin-G given i.v. two to three times a week for 4 weeks.”



A R T I C L E:

SAN MARINO, Calif., May 19 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies announced today the results of an on-going Phase I/II study of Rexin-G for metastatic pancreatic cancer (Chawla et al., ASCO meeting, 2008). Continuing on with the planned dose-escalations of Rexin-G which began in 2005 using lower doses of Rexin-G in a Phase I safety study (Molecular Therapy, 2008), the current Phase I/II study employed higher dose-escalations of Rexin-G given i.v. two to three times a week for 4 weeks, beginning with 8 x 10e11 cfu to 6 x 10e12 cfu with a goal to safely reach the point where the clinical anti-tumor activity of Rexin-G would be clearly and unequivocally demonstrated.

Caption: EpeiusThe results of this latest Phase I/II study of targeted gene delivery in vivo are very encouraging-intravenous infusions of Rexin-G demonstrated significant biological activity without toxicity in patients with progressive chemo-resistant pancreatic cancer. Once the overall safety record of repeated infusions of Rexin-G was clearly demonstrated, the FDA approved across the board intra-patient dose-escalations (an adaptive design) to gain better tumor control.

These higher doses of Rexin-G were associated with stabilization of disease, using both RECIST and International PET criteria, significant reductions in CA 19.9 levels, and an increase in median overall survival (greater than 6 months) which was twice that observed in the low-dose safety study. No dose-limiting toxicity was observed, even at these higher doses of Rexin-G, thus confirming that repeated infusions of Rexin-G are safe and well-tolerated.

The importance of these progressive dose-escalation studies - which clearly establish safety before escalating to more potent tumoricidal levels - is of primary concern in the development of a new genetic medicine like Rexin-G. Moreover, the establishment of a functional dose-response relationship is also of fundamental significance, not only in terms of basic pharmacology, but in establishing the physiological mechanisms-of-action that are of major importance in determining the predictability of a new anti-cancer agent, in establishing the optimal dose regimens for a given type of cancer, and ultimately in gaining regulatory approval for Rexin-G in the United States.

Taken together with the results of previous studies, the current on-going Phase I/II study confirms the exemplary safety and therapeutic potential of Rexin-G, the first and so far only targeted gene delivery system shown to be safe and effective in the clinic.

For more information about Rexin-G, on-going clinical trials in the USA and abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems, please contact Dr. Erlinda M. Gordon at egordon @epeiusbiotech.com.

On the Web: www.epeiusbiotech.com.

###


Copyright © 2008 by Epeius Biotechnologies Corporation and Send2Press® Newswire, a service of Neotrope® - all rights reserved. Information believed accurate but not guaranteed. Sourced on: freeNewsArticles.com.

Story Title: ASCO 2008: Tumor-Targeted Rexin-G Demonstrates Dose-Dependent Anti-Tumor Activity without Toxicity in Metastatic Pancreatic Cancer
• REFERENCE KEYWORDS/TERMS: Epeius Biotechnologies, , , metastatic pancreatic cancer, Drugs and Pharmaceuticals, , , .

IMPORTANT NOTICE: some content which is considered "old" or "archival" may reference an event which has already occurred; some content possibly considered "advertorial" may also reference a promotion or time-limited/sensitive offering, and in all of these instances certain material may no longer be valid. For notably stale content, you should directly contact the company/person mentioned in the text (Epeius Biotechnologies Corporation); this site cannot assist you with information about products/services mentioned in the news article, nor handle any complaints or other issues related to any person/company mentioned or promoted in the above text. Information believed accurate but not guaranteed as of original date of story [Mon, 19 May 2008 07:10:36 GMT].

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Drugs and Pharmaceuticals

Eularis to Address Marketing Return at Japanese Pharmaceutical Marketing Excellence Conference

Author: Eularis
Dateline: Mon, 12 May 2008

freeNewsArticles Story Summary: “TOKYO and LONDON, U.K., May 12 (SEND2PRESS NEWSWIRE) -- Dr. Andree Bates, president of the New York and London-based pharmaceutical analytics company Eularis, will be delivering a presentation on how to tell if you are making the wrong marketing decision. The Pharmaceutical Marketing Excellence conference takes place in Tokyo, Japan.”



A R T I C L E:

TOKYO and LONDON, U.K., May 12 (SEND2PRESS NEWSWIRE) -- Dr. Andree Bates, president of the New York and London-based pharmaceutical analytics company Eularis, will be delivering a presentation on how to tell if you are making the wrong marketing decision. The Pharmaceutical Marketing Excellence conference takes place in Tokyo, Japan.

Caption: Dr. Andree Bates, president of EularisAt 11:45 a.m. on Monday, 19 May 2008, Dr. Bates will deliver a presentation titled, "How to Tell if You are Making the Wrong Marketing Decision Using Marketing ROI." Bates will expose the limitations of current measurement techniques used to guide current marketing decisions. She will also provide attendees with ideas on how to put return measurements to work in making marketing decisions for their own pharmaceutical organizations.

Bates has gained wide recognition within the international pharmaceutical industry for her expertise in marketing return analysis. Under Bates' leadership, Eularis issued three related research reports in the past year, including: "Ensuring Profitable Return-on-Investment (ROI) in Pharmaceutical Marketing: Using Analytics and Metrics to Improve the Bottom Line," "Pharmaceutical Sales Force Effectiveness Metrics: Are You Measuring the Wrong Things?," and "Ensuring Profitable Patient Adherence Programs by Effectively Using Analytics to Release the Hidden Value Available to the Bottom Line from Adherence."

WHO: Eularis

WHAT: Presentation on How to Tell if You are Making the Wrong Marketing Decision Using Marketing ROI

WHEN: 19 May 2008 at 11:45 a.m. in Tokyo UTC (GMT + 9 hours)

WHERE: Pharmaceutical Marketing Excellence Conference: Conrad Hotel, Tokyo

About Eularis
Eularis provides sophisticated pharmaceutical analytics that provide data-driven insight into the financial impact of corporate and marketing decisions. Unlike traditional analytics approaches which are lengthy and whose reliance on historical or analogue data reduces their accuracy, Eularis' proprietary 94.8 Analytics Process is based on the current market situation. This proven approach helps pharmaceutical marketing teams to quickly plan, measure, validate, and optimize their sales and marketing performance. Eularis offers pre-launch analytics, marketing mix modeling (both professional and consumer), portfolio optimization, sales force effectiveness, managed care analytics, and patient compliance solutions.

Co-headquartered in London and New York City, although working internationally, the company has developed significant experience in the global pharmaceutical market through client engagements with AstraZeneca, GlaxoSmithKline, Merck, Pfizer and many others.

More information about Eularis: www.eularis.com.

All trademarks acknowledged.

 View This Release in Japanese (PDF)

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Copyright © 2008 by Eularis and Send2Press® Newswire, a service of Neotrope® - all rights reserved. Information believed accurate but not guaranteed. Sourced on: freeNewsArticles.com.

Story Title: Eularis to Address Marketing Return at Japanese Pharmaceutical Marketing Excellence Conference
• REFERENCE KEYWORDS/TERMS: Eularis pharma analytics, , , Pharmaceutical Marketing Excellence Conference, Drugs and Pharmaceuticals, , , .

IMPORTANT NOTICE: some content which is considered "old" or "archival" may reference an event which has already occurred; some content possibly considered "advertorial" may also reference a promotion or time-limited/sensitive offering, and in all of these instances certain material may no longer be valid. For notably stale content, you should directly contact the company/person mentioned in the text (Eularis); this site cannot assist you with information about products/services mentioned in the news article, nor handle any complaints or other issues related to any person/company mentioned or promoted in the above text. Information believed accurate but not guaranteed as of original date of story [Mon, 12 May 2008 01:25:00 GMT].

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