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Wednesday, May 31, 2006

 

Clinical Research Management Tools To Target Silver-level Compatibility

 
OpenClinicaTM Targets National Cancer Institute’s caBIG Silver-level Compatibility

Akaza Research announces that OpenClinica, will be one of the first clinical research management tools to target silver-level compatibility under the National Cancer Institute’s Cancer Bioinformatics Grid (caBIG) initiative.

CAMBRIDGE, MA (PRWEB) May 31, 2006 -- Akaza Research is pleased to announce that its next release of OpenClinica, codenamed “Sterling,” will be one of the first clinical research management tools to target silver-level compatibility under the National Cancer Institute’s Cancer Bioinformatics Grid (caBIG) initiative. caBIG is a major initiative of the National Cancer Institute to create a “World Wide Web of cancer research” with the stated goal “to eliminate death and suffering due to cancer by the year 2015.”

“This is a fantastic opportunity for OpenClinica and for cancer research”, said Cal Collins, Akaza Research’s President. “The cancer research community is already starting to reap the benefits of the Cancer Bioinformatics Grid. Because caBIG has embraced principles of open source and open standards, we can deliver our open source clinical trials platform, OpenClinica, in a way that adds materially to this value.”

OpenClinica’s Senior Product Coordinator, Tom Hickerson, said, “The National Cancer Institute is on the forefront of using technology to accelerate the progress of cancer research. With caBIG, the National Cancer Institute has recognized the need for systems to become more interoperable in order to deliver the productivity that modern science demands. OpenClinica ‘Sterling’ will provide the adaptability that such a task requires. OpenClinica™ enables sponsors and investigators to manage clinical trials in multi-site studies. It is this inherent flexibility of the system that enables OpenClinica to evolve so rapidly and to be deployed effectively in an integrated research environment,” Mr. Hickerson added.

The cancer Biomedical Informatics Grid™, or caBIG™, is a voluntary network or grid connecting individuals and institutions to enable the sharing of data and tools, creating a World Wide Web of cancer research. The goal is to speed the delivery of innovative approaches for the prevention and treatment of cancer. The infrastructure and tools created by caBIG™ also have broad utility outside the cancer community. caBIG™ is being developed under the leadership of the National Cancer Institute's Center for Bioinformatics. Additional information on caBIG compatibility may be found at
https://cabig.nci.nih.gov/guidelines_documentation.

Akaza Research, a leading provider of open source clinical trial software, is headquartered in Cambridge, Massachusetts. Supported by the National Institutes of Health (NIH), Akaza has developed and commercialized OpenClinica, the preeminent open source clinical trial data collection and management software platform. Akaza brings Open Source Software solutions into the mainstream of the clinical research enterprise by making high quality, standards-based systems accessible for private and public research. Akaza Research provides support, training, and consulting services to its customers worldwide. See www.akazaresearch.com.

OpenClinica™ is an open source web-based software platform that enables sponsors and investigators to manage clinical research data in multi-site studies. It facilitates protocol configuration, design of case report forms, electronic data capture, and study/data management. OpenClinica supports HIPAA and 21 CFR Part 11 guidelines and is designed as a strictly standards-based, extensible, and modular platform. OpenClinica v1.0 was released in October 2005 under the GNU Lesser General Public License (LGPL). See
www.OpenClinica.org. OpenClinica 2.0 is scheduled to be released to beta testers this summer.

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Press Contact: Steve Glines
Company Name: Industrial Myth
Email: email protected from spam bots
Phone: 978-952-6340
Website:
www.akazaresearch.com


Monday, May 29, 2006

 

Free Early Case Assessment of Electronic Information

 
MetaLINCS Offers Corporate Legal Teams and Law Firms Free Early Case Assessment of Electronic Information

Early Knowledge from E-Discovery Analysis Software Drives Early Action and More Favorable Case Outcomes

San Jose, CA (PRWEB) May 29, 2006 -- MetaLINCS™, a leading provider of E-Discovery software, today announced the availability of a trial offer that provides corporate legal teams, law firms and government agencies a free early assessment analysis of their electronic data pertaining to any legal matter. Qualified organizations can submit up to 10GB of electronic data for automated review and receive a customized Early Case Assessment Report of key results within 5 days. A sample report based on analysis of the Enron email database can be found at www.metalincs.com/promos/freeAssessment.html.

The free service specifically targets attorneys, investigators and litigation support professionals who desire a way to find key evidence in electronic information that is dramatically more reliable, timely and cost-effective than the current approaches to E-Discovery, which are almost entirely manual. Today's predominant best-practice methods for E-Discovery are dominated by service providers that employ a small army of people to collect, process and comb through electronic information. Not merely expensive, the service provider approach to E-Discovery is error-prone, time-consuming, and provides very limited visibility into the significance of the information discovered.

"The E-Discovery component of most legal matters and investigations come with short deadlines, which puts companies and law firms under tremendous pressure to produce information that can help them quickly assess their exposure and begin to build a case strategy," said Ramon Nunez, CEO of MetaLINCS. "Today's manual E-Discovery processes are too slow and tedious to allow for a fast, comprehensive understanding of the information at hand. Early case assessment enables legal teams to find and drill down on the most relevant case material during the earliest stages of a case and demonstrates the power of early knowledge."

E-Discovery is now the most costly component of the legal and investigatory process, and as it grows in complexity, the associated costs and risks continue to soar. The ability to assess cases at their earliest stages can reduce overall e-discovery costs by as much as 75%. Early assessment can also lead counsel to conclude that 80% of the data they processed is irrelevant, not requiring further examination. Such early insight can inform initial strategic decision-making and drive more favorable case outcomes.

Organizations that take advantage of the MetaLINCS' offer will receive a customized Early Case Assessment Report, featuring in-depth analysis results in the following areas:

Related Concepts – MetaLINCS provides a related concept analysis based on the keyword list you provide. This helps identify additional words and phrases that are relevant to the case.
Thread Analysis – For each of your keywords you can also see a list of the top email conversations involving that keyword. This analysis can help create a context for understanding each keyword and the people involved.

Social Network Analysis – Social Network Analysis shows the communication patterns of key individuals during critical time periods. These analyses reveal individuals you may not have known about or initially considered important to the case.
More information about this MetaLINCS free offer can be found at www.metalincs.com. Users can also register for the free Early Case Assessment by calling 1-800-221-6382.

About MetaLINCS eDiscovery Application
The MetaLINCS E-Discovery application offers corporate attorneys, investigators and litigators the most comprehensive E-Discovery review and analysis software available. The platform combines a patent-pending guided discovery process with a unique visual representation of the relationships between people, events, time, documents and communication patterns. This approach allows users to quickly gain an understanding of electronic information in context, which leads to more successful investigations, mitigates compliance risks, and reduces discovery and litigation costs.

About MetaLINCS
MetaLINCS is a leading provider of Electronic Discovery software. The company's flagship product, the MetaLINCS E-Discovery application, drives early and accurate case assessments by guiding users through the discovery process and suggesting new areas for analysis. Corporate attorneys, investigators and litigators are able to make better decisions earlier, boost discovery productivity, and ensure discovery consistency across cases. The MetaLINCS eDiscovery application is the first commercial software to visualize relationships between people, events, time, documents and communication patterns. Founded in 2003, MetaLINCS is a privately held company located in Mountain View, California and has received venture financing from ArrowPath Venture Capital, Newbury Ventures and Rembrandt Venture Partners. For more information about the company, visit www.metalincs.com.

MetaLINCS is a registered trademark of MetaLINCS. Any other marks used in this document are trademarks or registered trademarks of the manufacturers or marketers of the products with which the marks are associated.

###

Press Contact: Holly Berkley
Company Name: BERKLEY WEB STRATEGIES, LLC
Email: email protected from spam bots
Phone: 800 921 0687
Website:
http://www.metalincs.com


Wednesday, May 24, 2006

 

Cancer Survival Rates on the Rise

 
Cancer Survival Rates on the Rise Due to Increased Awareness from Resources Such as eCancerAwareness.com

The current trends in Cancer awareness and prevention are encouraging, but more needs to be done to help spread the word about this destructive disease. eCancerAwareness.com provides free blogs to Cancer survivors and anybody affected by Cancer. Keeping a Cancer Blog is a great way to provide information, keep a journal of one’s experience, or share the tale of a loved one’s fight against Cancer.

Sacramento, CA (PRWEB) May 24, 2006 -- A progress report released by the National Cancer Institute shows that while certain forms of Cancer such as Female Breast Cancer and Melanoma are on the rise, the average survival rates for all forms of Cancer are increasing. Cancer awareness is an overwhelming factor in this trend.

Web sites such as eCancerAwareness.com are helping to spread the word about Cancer, Cancer prevention, and general awareness toward fighting Cancer. The public is becoming more educated about treatments and early detection and the report shows that the current mortality rates for Cancer victims are dropping. Unfortunately, the numbers of Breast Cancer diagnoses, for example, is still on the rise. Obviously, there is still a long way to go and the general public needs to become more aware.

There are several ways that people can do their part to help support the Cancer Awareness cause. eCancerAwareness.com provides free blogs, or web journals, to anyone affected by Cancer, so the public can learn more about Cancer from those who have fought and won the battle, or are currently combating the disease. Anybody affected by Cancer is encouraged to sign up for their own blog to provide information, keep a journal of their experience, or tell the story of a friend or family member’s fight with Cancer.

There is also a vast amount of information related to Cancer available on eCancerAwareness.com, and the site provides an easy way for visitors to share the resource with friends and family. Web site owners and bloggers can also support Cancer awareness by taking part in the “Be Cancer Aware” campaign started by eCancerAwareness.com.

Awareness plays a very large role in the fight against Cancer and Cancer prevention. The over-all trends are optimistic, but there is always more that can be done to try to beat this disease that has impacted countless peoples’ lives. To help in the fight, eCancerAwareness.com provides information, blogs and many more resources, which are all free to the public.

For additional information, visit eCancerAwareness.com

About eCancerAwareness.com:

At eCancerAwareness.com, visitors can learn more about Cancer, get the latest Cancer-related news, sign up for their own Cancer blog and much more.

Contact Information:
Eric Kloss
eCancerAwareness.com
916-313-0617
http://www.eCancerAwareness.com

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Press Contact: Eric Kloss
Company Name:
Phone: 916-313-0617
Website:
http://www.eCancerAwareness.com


 

Yet Another Health Care Web Site Makes Searching For Info Faster And Easier

 
A New Health Care Web Site Makes Searching For Info Faster And Easier

Health Site Guide (www.healthsiteguide.com) is a user-friendly portal that features pre-searched links to a wide range of health care topics and concerns.

Great Neck, NY (PRWEB) May 24, 2006 -- Want to find a video that explains a medical procedure? Need to know more information about a drug you’re taking? Is that dry spot on your arm chapped skin or a skin condition? Now there’s a Web site with all the resources and features of the leading health care Web sites, and it’s all at one address www.healthsiteguide.com.

Started by a marketing executive who, like so many others, searched the Web to learn about a medical condition, then scrolled aimlessly down the results page, www.healthsiteguide.com is a free portal to pre-searched information contained on a wide range of health care sites. The site provides visitors with direct links to special features like videos, drug interaction information, medical encyclopedias, eldercare and much more, which can be accessed from a drop down menu or by clicking graphics on the home page.

Other drop down menus feature overviews on more than two dozen health care Web sites, written by professional science writers in an unbiased manner that doesn’t review the site, but simply presents the benefits to a prospective visitor. A third menu lists hundreds of health concerns with links to sites that contain information on the subject.

“One of the most popular reasons that people use the Internet is to research their health or the health of a loved one,” said Bob Lipp, president of Health Site Guide, Inc. “However, unlike other categories of Web sites like e-commerce sites, we weren’t able to find one site that would be a portal into many health care sites, with pre-searched links for fast and easy information access. So we created one.”

The site is also fully interactive, allowing visitors to communicate with one another through free member pages. All you have to do is enter a username and password to get started.

“Want to participate in a group forum on a subject of interest, create your own personal page or blog?” asks Bill Blaney, executive vice president of Health Site Guide. “It’s easy. Become a member, at no cost, and discover the many ways to enhance your health care learning and sharing experience. The site even features pages and pages of the latest health care news from leading news organizations.”

www.healthsiteguide.com is owned by Health Site Guide Inc. The site is a portal that makes it fast and easy to access a broad range of health care information and special features, which are available on today’s health care Web sites.

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Press Contact: Alan Lewis
Company Name: MARCOMM GROUP
Email: email protected from spam bots
Phone: 516-829-0404
Website:
www.healthsiteguide.com


Monday, May 22, 2006

 

Halliburton Fears Lawyer

 
Truth in Corporation Justice LLC Attorney Denied Access to Annual Halliburton Meeting

Meeting held in rural town, Duncan, Oklahoma under heavy security.

Oakland, CA (PRWEB) May 22, 2006 -- Special Counsel to the Lead Plaintiff in the Halliburton Company Securities Litigation, Neil Rothstein of Truth in Corporate Justice LLC (worldwidetree @ gmail.com), who attended the annual Halliburton shareholders meeting on May 17, 2006 in Oklahoma, was not permitted to enter the Simmons Center in Duncan where there were supposedly two hundred people gathered inside. The Lead Plaintiff, of the Archdiocese of Milwaukee Supporting Fund, Inc. (“AMS Fund”) is a current shareholder. The AMS Fund requested its attorney in writing to attend the meeting. The document, signed by an official at the AMS Fund, Vice President Paula N. John, authorized Mr. Rothstein to attend this meeting on its behalf and thereafter, to observe and report back to the AMS Fund, Inc. The Archdiocese of Milwaukee Supporting Fund, Inc. (“AMS Fund”) recently requested that Neil Rothstein be appointed Special Counsel to the Lead Plaintiff in the Halliburton Securities Fraud Class Action Litigation case (www.halliburtonsecuritieslitigation.com).

Mr. Rothstein is the Founder and Chief Managing Officer (“CMO”) of the Worldwide Tree™ Group. The group consists of Truth in Corporate Justice LLC (“TCJ”), and its subsidiaries, the Global Governance Center LLC, and Class in Action LLC. Additionally, the Group contains Worldwide Tree Multimedia LLC. Contact Truth in Corporate Justice LLC at 310/459-2560 or 800/610-4998 or Neil Rothstein directly at 619/251-0887. TCJ is a limited liability company that will scrutinize, support and endorse those law firms that adhere to TCJ’s ethical and competency standards in order to maintain the integrity of the legal system in the United States. TCJ seeks to empower anyone facing legal problems with education, access, guidance, networking and more. It avails its resources, access and knowledge to both plaintiffs and defendants and uses its power to empower those who have been injured by corporate greed or by corporations and their directors and officers who might be falsely accused of wrongdoing.

The following is an account of the events that occurred on May 17, according to attorney Neil Rothstein:

On Wednesday May 17, 2006 Halliburton held its annual meeting in Duncan Oklahoma, a rural town approximately two hours outside of Oklahoma City. The closest town that Rothstein could reserve a hotel room was in the town of Lawton, approximately thirty-five minutes from Duncan (which Rothstein was told had only about 90 motel rooms; Halliburton has well over 500,000 shareholders). Upon arriving at the Simmons Center, which according to its website can seat almost one thousand people, Rothstein presented the letter of representation that he had been given by his client. AMS had requested his attendance so as to uphold its fiduciary duty required by law in the ongoing securities litigation and because it was entitled to attend. He was permitted to park in the attendees’ parking lot after being stopped and having the document read by two law enforcement officers.

Approximately fifty feet from the entrance an officer dressed in plain clothes walked in front of him and asked him what he was doing there. Rothstein explained that he represented a shareholder and handed him the signed authorization letter. Without looking at the letter, or knowing who he was, he told Rothstein that he could not enter the building. Rothstein requested that the officer read the letter and the officer glanced quickly at the document, proceeded to fold it over and stated “This ain’t Milwaukee”. He then directed Rothstein to stand in the protestors’ area. Rothstein informed the officer that he was not a protestor and that he was there on behalf of his shareholder client. Before Rothstein could respond, the officer requested “backup”. Rothstein was never asked for identification, he was not able to speak to any Halliburton representative and the officer disallowed his entrance without consulting anyone from the Company.
Rothstein moved beyond the roped area as instructed.

Thereafter Rothstein heard helicopters flying overhead, looked up only to realize that S.W.A.T. forces were on the roof of the building. Rothstein then closely surveyed with detail: the countless number of armed law enforcement officials, a group of about sixty protestors and even a few masked demonstrators. Rothstein requested an Oklahoma City attorney to find a person who would get his authorization to David Lesar, the CEO of Halliburton. A little while later he was given back the document and was told that it was believed that three Halliburton representatives had reviewed the document and would not permit his entrance. (Rothstein cannot verify that any representative of Halliburton reviewed the document).

Rothstein took one more look around and decided to leave. Thereafter, he drove two hours from the remote location and left Oklahoma. Rothstein reported to his client that he was denied access to the meeting and that he later learned the meeting had less than two hundred attendees.

The Litigation: Recently, Halliburton and certain individual defendants filed a Motion to Dismiss in the securities litigation, a major part of which was denied by the Court. This is a noted case, as the AMS Fund objected and blocked a previously announced $6 million settlement and had the other lead attorneys and plaintiffs removed from their leadership positions (some withdrew voluntarily prior to their potential dismissal). Pursuant to the Court order, an updated complaint has been filed. Information regarding this litigation case can be found at the Halliburton litigation website indicated above as sponsored by Truth in Corporate Justice LLC. Click the tab of interest (Archdiocese of Milwaukee Supporting Fund Inc., et. al. v Halliburton Company, et. al., United States District Court for the Northern District of Texas, C to maintain the integrity of the legal system in the United States. iv. Action No. 3:01-cv-1152-M)

This Halliburton Securities Class Action website is maintained solely by Truth In Corporate Justice LLC. It is not connected to the Court (Northern District of Texas), any law firm or any other party in this litigation. Truth in Corporate Justice LLC and its subsidiaries, Class in Action LLC, and The Global Governance Center LLC were formed to maintain the integrity of our nation’s legal system. “Justice can only be served when learned judges are efficient, coupled with zealous and ethical attorneys advocating for all parties, allow their clients – both plaintiffs and defendants -- to control and direct their litigation and show up in court for all proceedings. TCJ seeks to use its power to empower anyone to get the education and knowledge to obtain the very best legal representation and resources available,” said Neil Rothstein. TCJ contributes not less than ten percent of any profits to the Worldwide Tree ™ Group, which is dedicated to foundations, endowments and scholarships. TCJ believes that no voice should go unheard. No organization that advocates the use of violence or terrorism may receive the assistance of any company under the umbrella of the World Wide Tree Group.

Truth In Corporate Justice LLC attended this meeting at the written request of its client-- a shareholder who is lead plaintiff in the Halliburton case--so that it could be fully informed and therefore carry out its fiduciary duty as required by law to the absent class members in the purported class action. In light of ongoing news of impending indictments of certain class action attorneys and their law firms (the law firm of Milberg Weiss Bershad & Schulman--formerly Milberg, Weiss, Bershad, Hynes & Lerach--and two attorneys from that firm were indicted Friday), the foundation desired to continue to carry out its duties to its fullest extent. TCJ believes that Halliburton should reimburse any costs incurred to any person or entity that had a right to attend this meeting and was denied the ability to enter the building. Further, the proper federal agency should inquire as to why any shareholder or its representative was denied access to attend. TCJ is of the belief that the class action lawsuit is the optimal legal proceeding for cases where the number of people affected are too numerous. “When a learned judge is appointed to the bench and selects attorneys on both sides who are zealous advocates with high ethical standards, then, coupled with lead plaintiffs and defendants who attend court hearings and direct and control their litigation by active participation, justice more often will be served,” said Rothstein.

Contact:
Neil Rothstein
Truth in Corporate Justice LLC
800-610-4998
worldwidetree @ gmail.com
www.halliburtonsecuritieslitigation.com

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Press Contact: Neil Rothstein
Company Name: Truth in Corporate Justice LLC
Phone: 800-610-4998
Website:
www.halliburtonsecuritieslitigation.com


 

Purchasing Prescription Pills Provided By Pharmacy Sites

 
Purchasing Prescription FDA Approved AntiDepressants Can be Legally Purchased from U.S.-Based Internet Pharmacy Sites

Searching for FDA approved antidepressants online? Buy-AntiDepressants-Online.com complies with DEA regulations for doctors approving and pharmacy shipping prescription antidepressants. Online doctor or pharmacist consultations are always available. Buy-AntiDepressants-Online.com is committed to meeting and exceeding all government regulations for supplying prescription antidepressants to patients.

(PRWEB) May 22, 2006 -- Although some online pharmacies are legitimate businesses, patients must be cautious when purchasing drugs over the Internet. Patients should not buy drugs from web sites that: are not registered on a search engine; sell drugs not approved by the HHS Food and Drug Administration (FDA); do not offer the opportunity to ask questions of a registered pharmacist; require that you link to another web site to purchase the drug; and do not provide a U.S. phone number or a way to contact them for questions.

At Buy-AntiDepressants-Online.com the patient no longer needs to receive a traditional physical exam by the physician. It must be said that online consultations can never take the place of traditional medicine but they do provide a valid means for patients to receive treatment for a number of conditions that, in many circumstances, do not actually require a physical exam. The patient completes an online questionnaire; the questionnaire is then submitted to the physician for review. If approved a written doctor’s prescription is sent to a certified pharmacy for filling. Some examples of prescription antidepressant medications can be found at: Buy-AntiDepressants-Online.com/buy_antidepressantsonline_sitemap.html.

Buy-AntiDepressants-Online.com employs the services of highly trained and qualified pharmacists to provide you with the high standards of pharmaceutical care that you have come to expect and will only refer your order to certified physicians that are fully licensed. Buy-AntiDepressants-Online.com is committed to meeting and exceeding all government regulations covering this new form of health care. All medicines provided are obtained from legitimate pharmaceutical distributors or in some cases directly from the manufacturer, in this way you can be sure that you receive at all times the same quality medication that you would receive from your neighborhood drugstore.

Buy-AntiDepressants-Online.com has information and links on their website covering such topics as the importation of medications into the U.S. and the exportation of medications outside the U.S. There is a need for a consumer to obtain clarity from the seller’s website. Also, some medications are considered controlled substances. The law requires that before these medicines can be dispensed that you undergo a physical exam, this means we cannot sell them online. Such medicines include Xanax and Valium.

Patients that are looking to purchase prescription antidepressants online like Prozac, Paxil, Celexa, Wellbutrin, Lexapro, Elavil and other prescription antidepressants can do so safely at Buy-AntiDepressants-Online.com.

Visit http://www.Buy-AntiDepressants-Online.com/index.html for more information and prices for prescription antidepressants.

# # #

Press Contact: Alan Previtali
Company Name: L.I. NETWORK MARKETING
Phone: 631-821-1398
Website:
http://www.Buy-AntiDepressants-Online.com


Wednesday, May 17, 2006

 

Inoperable Mesothelioma Survival Improves With ONCONASE® (ranpirnase)

ONCONASE® Improves Survival in Inoperable Mesothelioma
According to a press release from Alfacell Corporation, the addition of ONCONASE® (ranpirnase) to Adriamycin® (doxorubicin) improves survival over doxorubicin alone in patients with inoperable mesothelioma.
 
Malignant pleural mesothelioma is a rare cancer that develops in the tissue that covers the lungs and lines the interior of the chest. It is often caused by chronic exposure to asbestos. The majority of patients are not diagnosed until the disease has progressed to an advanced stage and treatment with surgery or radiation is not an option. Patients with this disease often have a decreased quality of life due to symptoms such as shortness of breath, cough, pain, fatigue, and the inability to eat.
 
Mesothelioma is fairly resistant to most therapies, including surgery, chemotherapy, and radiation therapy. Therefore, finding a chemotherapy regimen or new therapeutic approaches that can improve quality of life or survival is essential for improving care in this population.
 
ONCONASE is an agent that is meant to target cancerous cells while sparing healthy cells from side effects. ONCONASE is taken into cancerous cells, where it kills the cell through various processes. ONCONASE is not yet approved by the U.S. Food and Drug Administration (FDA).
 
Researchers recently conducted a clinical trial to evaluate the addition of ONCONASE to doxorubicin compared with doxorubicin alone in the treatment of inoperable mesothelioma. This trial included 143 patients. Results are below:
 
Median survival was improved by two months with the addition of ONCONASE (12 months for patients treated with ONCONASE/doxorubicin compared with only 10 months for those treated with doxorubicin alone). At one year 47% of patients treated with ONCONASE/doxorubicin were alive compared with only 36% of patients treated with doxorubicin only.
The median duration of disease regression or disease stabilization was improved by seven months in the group of patients treated with ONCONASE/doxorubicin (17 months) compared to those treated with doxorubicin alone (10 months).
The researchers concluded that the addition of ONCONASE to doxorubicin improves outcomes compared to doxorubicin alone in the treatment of inoperable malignant mesothelioma. Future trials evaluating the addition of ONCONASE to more effective chemotherapy agents in the treatment of mesothelioma are warranted to determine its true clinical effectiveness.
 
Reference: Alfacell Corporation. Alfacell Provides Update on ONCONASE Phase IIIb Confirmatory Registration Trial; Releases First Interim Analysis Data. Available at: http://www.snl.com/irweblinkx/file.aspx?IID=4104784&FID=2237286. Accessed May 2006

Ranpirnase Effective in Malignant Mesothelioma

According to a recent article published in the Journal of Clinical Oncology, ranpirnase (Onconase) appears to be an effective novel treatment option for malignant mesothelioma.
 
Malignant pleural mesothelioma is a rare cancer that develops in the tissues that comprise the lining of a lung (pleura). The majority of individuals who develop malignant pleural mesothelioma have experienced chronic exposure to asbestos during the course of their lives. This type of cancer is considered to be resistant to standard therapies, which consist of surgery, chemotherapy and/or radiation therapy. The majority of available chemotherapeutic regimens produce an anti-cancer response rate of approximately 20% or less, with a minority of patients surviving one year following diagnosis. Due to these poor survival statistics, researchers are continually evaluating new treatment approaches in an ongoing attempt to improve upon present treatment outcomes.
 
Ranpirnase, a ribonuclease, is a novel therapeutic agent that is entering the final phases of clinical trials prior to FDA approval for evaluation of the treatment of malignant mesothelioma. Ranpirnase is a small protein that is isolated from the eggs of Rana pipiens - a leopard frog. Ranpirnase initially binds to the surface of cells in the body and becomes internalized into the cells. It works by degrading a protein (tRNA) that is produced more readily when cells are growing and replicating. The irreparable degradation of tRNA can directly kill a cell or can signal a cell to stop replicating. Since cancer cells replicate more frequently and tend to have higher levels of tRNA than normal cells in the body, they are more susceptible to the effects of ranpirnase.
 
A multi-institutional clinical trial was recently conducted to evaluate ranpirnase in 81 patients with malignant mesothelioma. All patients had cancer that was considered inoperable and was progressing at the time of initiation of the trial. Thirty-five patients experienced a stabilization of their cancer and six patients had a regression of their cancer. Survival rates for all patients at one and two years following therapy were 42% and 26.8%, respectively. Importantly, the 41 patients who responded to therapy had one and two year survival rates of 61% and 40.8%, respectively. Ranpirnase was given once a week on an outpatient basis. Treatment was generally well tolerated, with the most common side effects being weakness, swelling of the hands and feet and joint pain.
 
These results indicate that ranpirnase appears to be an effective and safe treatment option for patients with malignant mesothelioma. This is an important finding as patients with progressive and/or inoperable malignant mesothelioma have limited treatment options and dismal long-term outcomes following standard therapies. A clinical trial is currently ongoing to directly compare doxorubicin, a commonly used chemotherapy agent, to ranpirnase plus doxorubicin in patients with inoperable or progressing malignant mesothelioma. Patient with malignant mesothelioma may wish to speak with their physician about the risks and benefits of participation in a clinical trial further evaluating ranpirnase. Two sources of information regarding ongoing clinical trials include the National Cancer Institute ( cancer.gov) and www.eCancerTrials.com. eCancerTrials.com also provides personalized clinical trial searches on behalf of patients. (Mikulski S, Costanzi J, Vogelzang N, et al. Phase II trial of single weekly intravenous dose of ranpirnase in patients with unresectable malignant mesothelioma. Journal of Clinical Oncology. 2002;20:274-281.)
 
 

Wednesday, May 10, 2006

 

Company Encapsulates Living Cells

 
Austrianova Biotechnology Starts Industrial Production of NovaCaps

Austrianova today announced that it has started industrial production of its lead product NovaCaps®. Austrianova is the first company worldwide that has been successful in developing a market scale, GMP compliant, industrial production process for encapsulated cell products.

Vienna, Austria (PRWEB) May 10, 2006 -- Austrianova Biotechnology sets up unique industrial manufacturing process for the GMP compliant production of encapsulated living cells.

Austrianova today announced that it has started industrial production of its lead product NovaCaps®. Austrianova is the first company worldwide that has been successful in developing a market scale, GMP compliant, industrial production process for encapsulated cell products. The implementation of the proprietary and unique manufacturing plant was realised with an investment of 6 Mill. Euro and took two and a half years. Austrianova’s GMP manufacturing plant has a capacity of 40,000 vials per year, sufficient to meet the projected demand for NovaCaps®. Contract partner, Miltenyi Biotec, supported Austrianova with expertise in the area of GMP production of biologics as well as providing GMP compliant production facilities in Frankfurt, Germany.

The set up of an industrial scale production of NovaCaps® represents an important advance for Austrianova since it demonstrates the industrial feasibility of the company’s reference project, a prerequisite for future commercialisation. With this advance, the manufacture of encapsulated cell therapies to medicinal product specification finally has become a reality. This opens very promising strategic options for the activation, regulation and transport of drugs since virtually any cell type can be encapsulated to immunoprotect the cells and to confine them to the site of delivery upon application into a patient. Moreover, the establishment of industrial scale, medically compliant production opens the doors for the application of Austrianova’s encapsulation technology to uses beyond the company’s immediate oncological focus. “Austrianova has reached an important milestone on its way to become a next generation drug delivery company," stated Thomas Fischer, Austrianova’s Managing Partner for Finance & Administration.

“The encapsulation technology is novel even at laboratory scale, but it was a tremendous challenge to scale the procedure for industrial production," commented Brian Salmons, Austrianova’s Managing Partner for Research & Development. New machinery had to be designed and developed by Austrianova personnel to meet GMP standards. Stringent criteria, in terms of reproducibility and product quality, which has to maintain critical tolerances, had to be fulfilled. In addition, comprehensive documentation standards needed to be established.

NovaCaps® has received orphan drug designation for the currently most poorly treatable indication, pancreatic cancer, from the European Medicines Agency (EMEA). The ability to provide consistent and quality assured batch manufacturing of NovaCaps® satisfying European market demand is a prerequisite for EMEA market authorisation based on the upcoming phase III clinical trial data planned to start early 2007.


About Austrianova Biotechnology GmbH:
Since the company was founded, in December 2001, Austrianova has matured from the first Biotech spin-off of the University of Veterinary Medicine, Vienna to its present status as a development focussed producer of biological medicaments with an innovative pipeline. Austrianova represents a precedent for the successful collaboration of university and industrial partners, the so-called integration model. The Company is at the forefront of the growing Austrian Biotechnology Industry and employs a staff of 25, with an additional 35 University staff.

About NovaCaps®:
The cell based therapy, NovaCaps®, is based on the encapsulation of genetically modified cells that are implanted in the vicinity of solid tumours. Encapsulation of the cells is achieved using a unique procedure and protects the cells from the patients immune system. The cells have been modified to produce an enzyme that converts a non-toxic chemotherapeutic agent to its tumour toxic form at the site where it is needed (Prodrug Therapy). The NovaCaps® treatment extends the survival of the patient while reducing side effects and improving the quality of life. Austrianova has received orphan drug status for NovaCaps® in the E.U. for the treatment of pancreatic cancer.

Pancreatic cancer
Pancreatic cancer is one of the most serious forms of cancer with a poor prognosis and limited treatment options. It is estimated that each year there are around 120,000 new cases of pancreatic cancer in the E.U., U.S. and Japan – around 50,000 of these occur in the E.U. alone translating into an E.U. market volume for NovaCaps® of around Euro 300 million.

About GMP (Good Manufacturing Practice):
The term “Good Manufacturing Practice”, abbreviated to GMP, was introduced by the American Health Authority, FDA (Food and Drug Administration). GMP requires that all critical steps in the production of medicinal products are reproducible and controlled as well as precisely documented. The whole pharmaceutical and biotech industry adheres to GMP for the production of medicines. GMP certification is granted by the regulatory authorities and inspection of production facilities for compliance with GMP is regularly performed.

About Miltenyi Biotec GmbH:
Miltenyi Biotec is one of the most successful German Biotech companies. Miltenyi Bioprocess provides GMP contract manufacturing support for the production of pharmaceutical products.

###

Press Contact: Brian Salmons
Company Name: AUSTRIANOVA Biotechnology 
 
Phone: +431250772601
Website:
www.austrianova.com


Monday, May 08, 2006

 

First Human Cord Blood Stem Cells to Turn into Lung Cells

BioE Stem Cell First Human Cord Blood Stem Cell to Turn into Lung Cell; University of Minnesota Researchers Differentiate MLPC into Type II Alveolar Cells
 
ST. PAUL, Minn.--(BUSINESS WIRE)--May 8, 2006-- Studies Continue to Evaluate Clinical and Therapeutic Potential of Rare Cord Blood Stem Cell to Treat Respiratory Conditions   
 
BioE(R), Inc., a biomedical company providing human cord blood stem cells as enabling, high-quality cellular tools for drug discovery and therapeutic research, announced today researchers at the University of Minnesota, using BioE's proprietary stem cell isolation technology, derived the company's Multi-Lineage Progenitor Cell(TM) (MLPC(TM)) from cord blood and differentiated it into lung cells responsible for making surfactant, a substance enabling respiration.
 
To the researchers' and BioE's best knowledge, this is the first time human stem cells -- from any source -- have differentiated into type II alveolar cells, the type of epithelial cells that help stabilize the lung's air sacs during breathing. Type II alveolar cells also can turn into type I alveolar cells, which form the thin, blood-gas barrier through which gas exchange occurs during respiration. Results of the University of Minnesota's MLPC study were presented this past weekend at the International Society for Cellular Therapy's (ISCT's) 12th annual meeting in Berlin.
 
"Turning a cord blood stem cell into an alveolar cell represents a significant milestone in stem cell research," said David McKenna, M.D., assistant professor of Lab Medicine and Pathology and assistant medical director of the Clinical Cell Therapy Lab at the University of Minnesota, and BioE research collaborator. "Though further research is needed, it's plausible the MLPC could be used to help develop a human lung model for research purposes and/or eventual therapeutic application to treat a number of respiratory conditions -- such as emphysema and pulmonary fibrosis, as well as pulmonary injury due to therapy-related causes."
 
The results of the University of Minnesota study also further demonstrate the MLPC's unique ability as a cord blood stem cell to expand and differentiate -- in a controllable fashion -- into tissues representative of the three germinal layers (e.g., ectoderm, mesoderm and endoderm), which give rise to the body's more complex tissues, organs and organ systems. Typically, researchers confirm endodermal potential by differentiating a stem cell into hepatic (liver) cells. In the case of the MLPC, researchers have demonstrated its endodermal potential by turning it not only into liver and pancreas precursors, but now, alveolar cells.
 
"The latest University of Minnesota research on the MLPC confirms our belief that it has vast potential as a robust research tool," said Michael Haider, president and chief executive officer for BioE. "The availability of a highly functional human lung model in vitro is something that has eluded researchers for some time and will prove to be very valuable for studying respiratory conditions. We look forward to working with Dr. McKenna and his team to translate this early MLPC discovery into a human model for lung disease research in the near future and potentially therapeutic applications thereafter."
 
About BioE
 
Headquartered in St. Paul, Minn., BioE is a biomedical company providing human cord blood stem cells as enabling, high-quality cellular tools for drug discovery and therapeutic research. The company's novel Multi-Lineage Progenitor Cell(TM) (MLPC(TM)) -- derived from human umbilical cord blood and obtained using PrepaCyte(R), the company's proprietary cell isolation platform -- provides clinicians and researchers a flexible, long-term and non-controversial tool for therapeutic research and drug discovery and screening. BioE is privately owned and was founded in 1993. For more information about the company, please visit www.bioe.com or call (800) 350-6466.
 
Contacts
Haberman & Associates
Jon Zurbey, 612-372-6446
jon@habermaninc.com
or
Amanda Kohls, 612-372-6453
amanda@habermaninc.com

 

Drug Safety Newsletter Offered By ePharmaceuticals

 
ePharmaceuticals Launches Drug Safety Newsletter

ePharmaceuticals, a division of healthcare regulatory publisher HCPro, has launched of Briefings on Drug Safety, a monthly electronic newsletter that will provide information and guidance to help pharmaceutical professionals make smart drug safety, risk management, and marketing decisions.

Marblehead, MA (PRWEB) May 8, 2006 -- ePharmaceuticals, a division of health care regulatory publisher HCPro, has launched of Briefings on Drug Safety, a monthly electronic newsletter that will provide information and guidance to help pharmaceutical professionals make smart drug safety, risk management, and marketing decisions.

With thousands of Vioxx-related product liability lawsuits, tighter oversight by the FDA’s new Office of Drug Safety, FDA-mandated risk management plans and risk communication, and intense Congressional and media scrutiny, drug safety is in the spotlight more than ever before. These factors have created an environment in which pre- and post-approval drug safety, risk management, and risk communications can make or break a drug.

“The drug safety stakes have never been higher, and that’s why drug safety, regulatory, legal, and marketing professionals in the pharmaceutical and biotech industries need this newsletter,” said David Beardsley, publisher of Briefings on Drug Safety.

Briefings on Drug Safety is designed to help readers effectively initiate post-approval safety studies, prepare for rigorous FDA oversight of drug safety, comply with adverse event reporting requirements, and design risk management and risk communications plans.

This new launch further expands ePharmaceuticals’ line of informational and training products on regulatory compliance in the life sciences industries. These products and services take the form of newsletters, audio conferences, webcasts, training handbooks, e-learning, and on-site workshops. They cover such topics as drug safety/risk management, Part D compliance, formulary and reimbursement issues under Medicare Parts B & D, and marketing innovation.

For more information, including a complimentary copy of Briefings on Part D Compliance, please visit:
http://www.hcmarketplace.com/prod-4032-EN44013A.html

About ePharmaceuticals
ePharmaceuticals, a division of health care regulatory publisher HCPro, Inc., provides business intelligence, compliance training, market research reports and custom publishing services to the pharmaceutical industry.

Publications include ePharm5, a daily business and marketing innovation newsletter, Medicare & Reimbursement Advisor Weekly, Briefings on Part D Compliance, Briefings on Drug Safety, and Pharmaceutical Compliance Alert.

Our compliance training resources include handbooks, audioconferences, live workshops, and online learning courses.

Contact: David Beardsley
Company Name: ePharmaceuticals
Phone: 8774374276
Website: http://www.hcmarketplace.com/prod-4032-EN44013A.html


Friday, May 05, 2006

 

Asbestos Cancer Concerns Continue for Mechanics

 
New Reports Show a Return of Asbestos Concerns for Mechanics

More than a decade after most U.S. automakers stopped installing brakes containing asbestos, rising concerns have resurfaced in regards to brakes that are imported to the U.S. from countries where using asbestos in auto parts is still the norm.

(PRWEB) May 4, 2006 -- According to recent reports and a Baltimore Sun Newspaper Article, during the last 10 years, there’s been an 83% increase in the use of imported brakes in car repairs throughout the country, yet OSHA and other safety organizations have not seen fit to issue precautions throughout the industry, a fact that has angered many mechanics and auto shop workers who were unaware of the hazards they were facing on an almost daily basis.

Problems, say health officials, are compounded by the fact that many mechanics believe asbestos was banned in the United States more than 3 decades ago. That’s simply not the case. While warnings were issued in the 1970s and automakers stopped using the material about a dozen years ago, asbestos is still a legal product. As a matter of fact, the U.S. is one of the few industrialized countries that hasn’t banned the importation or use of asbestos which, when inhaled, can cause mesothelioma or other asbestos-related lung diseases.

A pamphlet touting the concerns of asbestos exposure in the auto industry was issued by the Environmental Protection Agency more than 20 years ago, but no warnings have been published in written form since that time. New mechanics, of course, are among those that are the least aware of the dangers of inhaling the material, which was used in brakes and other mechanical parts for several decades prior to their employment.

Occupational health specialists note that older mechanics were exposed to huge amounts of the material as brakes were once made of 50% asbestos. Thousands of workers in the industry are diagnosed with mesothelioma or other asbestos-caused diseases annually.

Even more aggravating to advocates in the auto repair field is the fact that OSHA completed a pamphlet about the hazards of asbestos in their field nearly two years ago but chose not to publish or distribute it.

Most critics believe that the government's refusal to publish the literature was due to pressure from the auto repair industry, which is already facing thousands of lawsuits over health-related claims resulting from the use of asbestos in brakes.

More information on these reports and the diseases associated with asbestos can be found at http://www.mesothelioma.com and the article that broke this report can be found on the Baltimore Sun web site.


Press Contact: Steve Rinaldi
Company Name: IIMSNET.COM
Phone: 203-777-7799
Website:
http://www.mesothelioma.com  

mesothelioma 


Tuesday, May 02, 2006

 

Mesothelioma Cancer Site Offers Information On Mesothelioma

 

JustMeso Offers Information on Treatment Options
I-Newswire.com (press release) - USA
(I-Newswire) - Mesothelioma, the deadly disease that has been at the forefront of global medical and legal research for the last decade, is becoming ...

JustMeso.com offers a plethora of information on treatment options for mesothelioma.
 
(I-Newswire) - Mesothelioma, the deadly disease that has been at the forefront of global medical and legal research for the last decade, is becoming increasingly susceptible to advanced treatment options.  While the disease is not yet curable, if caught very early there are a wide range of rather divergent medical treatment options which have had substantial success in limiting the harmful effects of malignant mesothelioma.
 
While there are a number of treatment options available, often there is a great deal of unknown information regarding what the procedures available are and how they work.  To that end, JustMeso.com (  http://www.JustMeso.com  ) has provided comprehensive information about the disease, its causes, and now the treatment options available to those diagnosed at its website.
 
The site explains in great detail the many traditional and new treatments available to those diagnosed with malignant mesothelioma, such as surgical solutions, radiation, and chemotherapy.  JustMeso.com breaks down each category into its component procedures as well as providing information on the extent of a procedure, its level of invasiveness, as well as an analysis of the costs and benefits of each specific procedure.  This analysis includes summaries of information on the effectiveness and the scope of the effectiveness of a particular treatment option. 
 
Combined, the information compiled by JustMeso.com in their treatment options section ( http://www.justmeso.com/treatment/ ), provides those diagnosed as well as their loved ones with a comprehensive resource from which they can attain a deeper understanding of the diseases as well as assess either own situation in light of the present treatment options available.  This information can prove valuable insofar as it will give individuals an excellent overview of the options available to them.  Through this information, individuals affected by mesothelioma can make more educated decisions about their own situation as well as be better situated to provide support for others. Of course, none of the information on JustMeso should be taken as medical advice, and a person should always consult their physician before taking treatment.
 
JustMeso.com ( http://www.JustMeso.com ) is based in the United States.  It was created with the intent of providing a single resource for individuals seeking information about malignant mesothelioma. 
 
If you have questions regarding information in this press release contact the company listed below. I-Newswire.com is a press release service and not the author of this press release. The information that is on or available through this site is for informational purposes only and speaks only as of the particular date or dates of that information. As some companies / PR Agencies submit their press releases once per week/month or quarter, make sure check the official company website for accurate release dates as our site displays the I-Newswire.com distribution date only. We do not guarantee the accuracy or completeness of information on or available through this site, and we are not responsible for inaccuracies or omissions in that information or for actions taken in reliance on that information.
 
More Information
JustMeso.com
Published on:
2006-02-14
 

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