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November 11, 2009
Austin biomedical company raises $3.5 million in backing
An Austin biomedical company has received $3.5 million in funding from the Texas Emerging Technology Fund and venture firms.
Ortho Kinematics has developed an investigational, non-invasive technology that allows surgeons to evaluate spine function in patients. Two U.S. hospitals and one in the United Kingdom have installed the technology, and the company said more hospitals will be adding it in the next six months.
“We are pleased to raise these funds in today’s challenging financing environment,” said Adam Deitz, CEO of Ortho Kinematics. “Our company now has the resources and commitment necessary to expand commercialization plans.”
Aside from the state Emerging Technology Fund, the new money is coming from PTV Sciences and Gatebridge Investments.
Deitz is a University of Texas alumnus and former consultant with Booz-Allen & Hamilton. He joined the company in 2006.
Related story: State tech fund seeding a new crop of Austin startups
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July 9, 2009
PPD cuts some Austin jobs
PPD Inc., which does clinical research for pharmaceutical and biotech companies, is cutting 270 jobs across its North American operations, including an unspecified number in Austin.
PDD has about 1,100 employees in Austin, out of 5,800 overall in North America.
The company, based in Wilmington, N.C., said the job cuts are a cost-cutting move tied to the impact of the global recession on PPD’s customers.
The job cuts, which affect a range of positions, will take effect July 16, said spokeswoman Louise Caudle.
The company reported a profit of $187.5 million on revenue of $1.6 billion for 2008.
“Even though the current market is challenging and requires us to take this action, we remain optimistic about the long-term outlook for our industry and for our company in particular,” Caudle said.
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December 3, 2008
Introgen files for bankruptcy
Austin-based Introgen Therapeutics Inc. filed for bankruptcy today, the latest blow in a tough year for the drug-development company.
Last week, the company’s longtime chief executive resigned, and the company laid off two-thirds of its employees.
“In light of our current financial state and recent market conditions, the company believes today’s actions represent the wisest alternatives for our shareholders, creditors and other stakeholders,” David Enloe, the new chief executive, said in a statement. “We are very optimistic about the promise of our contract manufacturing business and will continue to focus on growing our customer base in this area.”
The troubled biotech company has been unraveling since September, when the Food and Drug Administration rejected its application to market Advexin, a cancer-fighting drug on which it had been working for 14 years.i
Introgen has never made a profit. The company has $6.3 million in cash and short-term investments in its third quarter, compared with $14.9 million in December 2007, according to securities filings.
“Introgen expects to continue core activities pertaining to each of its business units during the reorganization process and expects to emerge from Chapter 11 during 2009,” the company said in a press release.
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September 2, 2008
Introgen shares plunge on FDA decision
Shares of Austin-based Introgen Therapeutics plunged more than 26 percent this morning after the company said the U.S. Food and Drug Administration had rejected its application for its cancer drug Advexin.
Introgen said the FDA had ruled that the application, submitted on June 30, was incomplete and would not be filed at this time. The company is seeking approval to market the gene-based drug to treat head and neck cancers.
This is a signifcant setback for Introgen, which has been working on Advexin for more than a decade. European regulators last month had accepted the application, a key step toward approving the drug for marketing.
Introgen CEO David Nance said the company would appeal the FDA’s decision.
“We will work with the FDA to determine our next steps in the U.S. as we continue to pursue potential approval in Europe,” he said.
Introgen shares were trading early today at 72 cents.
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July 14, 2008
Introgen stock tanks after TheStreet.com article
Street.com writer Adam Feuerstein has never been a big fan of local biotechnology company Introgen Therapeutics Inc., consistently writing articles about why the company is doomed to fail.
Unfortunately for Introgen, the street seems to listen to Feuerstein. The company’s stock is down 20 percent today after Feuerstein wrote another article about why Advexin, a gene therapy cancer drug that Introgen has been developing for 14 years, doesn’t work.
This is on top of a 60 percent slide in its stock price in the last two years.
Introgen applied June 30 for U.S. Food and Drug Administration approval of Advexin. It could know between six months to a year if it gains approval.
Previously, Introgen executives have speculated that Feuerstein has shorted the stock in the past, which basically means placing a bet the stock will go down. Introgen spokeswoman Channing Burke clarified this Monday, saying that “it’s my understanding that Feuerstein disclosed he worked for a hedge fund that shorted Introgen, just before he went to work for TheStreet.”
Feuerstein told me during a phone call this morning that it is against his company’s policy (TheStreet.com) to invest, short, or have any financial stake in any company, particularly a company he covers. He denies having any financial stake in Introgen. “I can only invest in mutual funds and my company’s stock,” he said.
One of the issues that Feuerstein and Introgen disagree on is its use of biomarkers. Introgen says Advexin works on patients with a certain genetic profile of the tumor suppressor p53 gene. Basically, the drug won’t work on all patients with head-and-neck cancer, just those with a certain level of the p53 gene.
Data from its phase III clinical trial seem to support this, and financial analysts, such as Joseph Pantginis from Canaccard Adams agree that Advexin does work.
Feuerstein takes issue with how Advexin accumulated its clinical data. He said Introgen completed its phase II trial results and only afterward decided to look at how patients with certain biomarkers responded. This retrospective analysis is at odds with the FDA’s preference on how clinical trials are run, he claims, and led to poor results because Introgen wasn’t able to obtain tissue samples of all of its patients.
But Introgen has said it has the blessing of the FDA in its analysis of biomarkers. This is the essence of what Advexin is, Introgen says. Because Advexin works to restore p53, it won’t work on patients that have a mutated p53, for example. And it points to a single patient under the care of Dr. John Hamm in Louisville as proof it does work — this person’s cancer is in remission and he has been receiving Advexin for 8 years.
Feuerstein raises other issues with Introgen’s data, but the central question remains: will the FDA buy that Advexin works, but only on certain patients? The answer is crucial to Introgen’s survival. The company has never turned a profit and relies on patient investors and money from contracts, grants and leases to survive.
Only time will tell.
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June 30, 2008
Introgen files for approval of cancer drug
After 14 years of development and several delays, Austin biotechnology firm Introgen Therapeutics has applied for U.S. Food and Drug Administration marketing approval for its head-and-neck cancer drug Advexin.
This is a milestone for Introgen. Although it has other drugs in the pipeline, gene therapy drug Advexin is the furthest along in the approval process.
If Advexin is approved, it will pave the way for other gene therapy drugs in Introgen’s pipeline to gain approval and help bring in much-needed revenue for the company.
The company has never posted a profit. It relies on federal grants, interest income, sale of its stock and rent from leases on the property it owns.
“This is a positive catalyst for Introgen,” said Joseph Pantginis, an analyst with Canaccord Adams who covers the company. Introgen will need to prove that its drug works, addresses an unmet medical need and is safe, Pantginis said.
If the FDA decides to put Advexin under priority review, a decision on whether to approve the drug could come as soon as six months.
If not, a decision could take at least a year.
Also Monday, Introgen filed for marketing approval for Advexin with the European Medicines Evaluation Agency, the equivalent to the FDA in Europe.
“This is an important milestone in the clinical application of gene therapy for cancer patients,” said Jack Roth, the inventor of Advexin and a professor at the M.D. Anderson Cancer Center. “Advexin will provide more effective and less toxic treatment for head and neck cancer patients who have limited options.”
According to Introgen, the drug is intended to treat patients who have the p53 biological marker. Not all cancer patients have this marker.
Clinical trials have shown that patients with the p53 biomarker who took Advexin lived a median of 7.2 months, versus patients with the biomarker who took chemotherapy drug methotrexate and lived a median of 2.7 months.
Part of Introgen’s challenge will be to convince the FDA that the drug indeed works — but only on cancer patients with the p53 biomarker. Those who do not have it are not likely to show any statistically significant improvement.
This strays from conventional thinking, where medicines are used to treat a certain illness, not targeting patients based on genetic markers.
Introgen was established in 1993 to specialize in targeted molecular therapy. Advexin works by using a deactivated cold virus to insert the p53 tumor suppressor gene into cancer cells. This kills the cancer cells without damaging healthy ones.
Although Introgen promised investors it would file for FDA approval “in the first half of 2008,” some were skeptical Introgen would live up to its promise, Pantginis said. The stock price ticked up about 1 percent on Friday to close at $1.051.
“There is a clear lack of investor interest right now,” Pantginis said. “They didn’t believe the (application) was going to be filed.”
The company had delayed filing for approval several times, the last in December, when Introgen said it had discovered missing samples from its clinical trials that it wanted to include in the data analysis.
Introgen is one of Austin’s most well-known biotechnology companies and the only one that focuses on developing gene therapy drugs.
UPDATE: Monday morning, Introgen’s stock was up nearly 12 percent, trading near $1.70.
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June 18, 2008
Two Austin companies win state emerging technology grants
Two companies with Austin ties will split $3.7 million in grants from the state’s Emerging Technology Fund, which is designed to spur commercialization of research in Texas.
Terapio Inc. will receive $1.7 million to develop a cream to treat hand-foot syndrome, a side effect of several chemotherapy drugs for certain cancers.
Receptor Logic Inc. will receive $2 million to advance its work in the development of antiobodies that can improve the understanding of the immune system and thus lead to better drugs and vaccines.
The company, with headquarters in Austin and a laboratory in Abiline, earlier this year signed a licensing agreement with Sanofli Pasteur, a world leader in vaccines.
Receptor Logic is a portfolio company of Emergent Technologies Inc., an Austin-based life sciences venture firm.
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January 15, 2008
ViaGen's statement on FDA approval of cloned meats
Austin-based ViaGen Inc. has released this statement on the U.S. Food and Drug Administration’s approval of meat and milk from cloned animal and their offspring for human consumption:
“ViaGen applauds the release of the U.S. Food and Drug Administration’s (FDA) rigorous scientific analysis of the safety of food from cloned animals and their offspring.
FDA’s determination that meat and milk from animal clones is safe to eat concludes the most extensive food safety review in FDA’s history, and complements two earlier reports from the National Academy of Sciences that reached the same conclusion.
Cloning companies will continue to work out an orderly marketing transition with the food industry and relevant government agencies - including FDA and USDA - as we move toward commercialization.
The number of cloned animals in the barnyard today is miniscule compared to the size of the total livestock population. In addition, clones are to be used as breeding animals, not for consumption. Because of a supply chain management system that allows tracking of cloned livestock, consumers are unlikely to ever eat these animals.”
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January 11, 2008
ViaGen cheers European approval of cloned meat products
Austin biotech company ViaGen has cheered the initial European approval of meat and milk from cloned animals and their offspring.
The European Food Safety Authority released its draft report Friday saying that meat and milk from cloned animals are safe to eat, according to ViaGen.
Last year the U.S. Food and Drug Administration released a risk assessment saying it thought meat and milk from cloned animals and their offspring were safe to eat, too.
But the FDA waited months to allow the public to weigh in and is on the brink of issuing its final assessment on the topic, which could allow companies like ViaGen to start producing more cloned animals for livestock producers.
ViaGen issued this statement today:
“In light of the European Food Safety Authority’s strong endorsement of the safety of food from clones and their offspring, we urge the U.S. Food and Drug Administration to release its final risk assessment at the earliest possible moment and to lift the voluntary moratorium. The international scientific consensus is clear: food from these animals and their offspring is as safe to eat as any other food. The opportunity to increase the availability of exceptional breeding stock offers great benefits to producers and consumers worldwide.”
But not everyone is happy with the momentum. The International Dairy Foods Association said this in a press release today:
“Nothing is more important to milk processors than the trust people have in milk and milk products. That is why we urge the FDA to listen to the more than 30,000 comments the agency has received over the last year and take the time to respond to their comments and concerns before allowing milk from cloned cows into the food supply.”
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April 10, 2007
UT licenses technology to biotech startup
A news release from Beacon Sciences LLC:
Beacon Sciences, LLC, announced today that it has obtained an exclusive license from the University of Texas at Austin for a “lock and key” chemistry platform for the detection of a wide variety of chemical and biological agents for medical and industrial diagnostic applications. Beacon Sciences, LLC, is an Emergent Technologies Fund IV portfolio company.
A key aspect of the technology platform is its ability to generate a chemiluminescent signal - or “glow” - when an agent is detected. A world-renowned leader in supramolecular recognition and binding, Eric Anslyn, Ph.D, is Chief Scientist of Beacon Sciences. Damon Borich, M.D., and Brian Windsor, Ph.D., will serve as Co-Managing Directors of the company, both of whom have extensive experience in assay development and commercialization.
Anslyn is one of the top scientists in the world in creating chemosensors, and has recently extended this expertise to the field of “glow chemistry.” His research has encompassed physical organic and bio-organic chemistry, specializing in the use of synthetic receptors for sensing and catalysis applications.
A Ph.D. graduate from the California Institute of Technology and Columbia University National Science Foundation Post-Doctoral Fellow, he now serves as Norman Hackerman Professor of Chemistry at The University of Texas at Austin.
Among his numerous accolades, Dr. Anslyn was named the 2006 Cope Scholar by the American Chemical Society for his pioneering research in the fields of pattern recognition and supramolecular chemistry, and was recently elected a Fellow of the American Association for the Advancement of Science. His research has applications in environmental, industrial and medical diagnostics.
“Synthetic receptors are now commonly used in academic and industrial settings, and Beacon Sciences has the unique ability to create such receptors for many different kinds of analytes,” Anslyn said. “Using new chemical principles, these receptors can be used to signal the presence of their target analyte by producing a naked-eye visible glow.”
While many chemiluminescent assays use enzymes or antibodies, Beacon Sciences’ assays do not require either of these biological molecules and are compatible with a wide variety of compounds, even non-immunogenic metals, cations, and anions.
“We are actively screening collaborative partners who need specialized binding assays for novel biomarkers and other important analytes,” Borich said. “Development licenses are available for a variety of fields, including clinical diagnostics, drug discovery, or other life sciences.”
The exclusive-licensed assay development platform utilizes supramolecular recognition chemistry, or “lock-and-key” chemistry, rather than antibodies or enzymes to create a binding event in an assay. Custom chemistry scaffolds enable Beacon Sciences to design a custom, non-biological receptor for many classes of biological or non-biological molecule - even those too small for current antibody-based assays to detect. The technology is also compatible with existing assay techniques and can possibly improve antibody- or enzyme-based assays.
Windsor, who also serves as Senior Vice President of Business Development for ETI, said, “We are very excited to be working with research leader and innovator, Dr. Anslyn. Beacon Sciences is the second company to be funded from the ETI Fund IV. Our joining with Beacon Sciences further strengthens ETI’s role in funding and developing early-stage companies whose clinically relevant and commercially viable products and services address large or emerging markets.” ETI is a venture capital firm focused on early technology deals from universities with the goal of partnering with industry leaders to commercialize the technology.
Chemiluminescence
Chemiluminescence (CL) is a highly sensitive detection method used in life science research and clinical diagnostics. CL is one of several types of luminescence that specifically involves a chemical reaction for which light is one of the products released. CL assays typically involve an activator molecule, that, in the presence of the target analyte, is triggered to relax some of its high-energy electrons, resulting in the release of light that be can quantified by the naked eye or simple instrumentation.
About Beacon Sciences
Beacon Sciences is a biotechnology company founded on the pioneering research of Dr. Eric Anslyn and his research team. The Beacon Sciences platform utilizes supramolecular recognition chemistry rather than antibodies or enzymes to create a binding event in an assay. Custom chemistry scaffolds enable Beacon Sciences to design a custom, non-biological receptor for many classes of biological or non-biological molecule - even those too small for current antibody-based assays to detect. The technology is also compatible with existing assay techniques and can possibly improve antibody- or enzyme-based assays. It has wide-ranging applications, including medical diagnostics, biowarfare detection, molecular tools, environmental monitoring, food and beverage testing, chronic disease monitoring, and pre-clinical drug safety testing. Beacon Sciences is actively seeking in-licensing opportunities for novel biomarkers and rapid detection analyte markers. For more information, visit the Beacon Sciences website, www.beaconsciences.com.
About Emergent Technologies Fund IV, L.P.(a)
Emergent Technologies Fund IV, L.P., (Fund IV) has been established to invest in early-stage companies formed to commercialize technologies created, developed, owned, and/or synergistic with The University of Texas System. The UT System consists of nine academic and health institutions and, in fiscal year 2007, spent in excess of $1.8 billion in research endeavors. This resulted in 117 U.S. patents and 655 invention disclosures last year alone.
About Emergent Technologies, Inc.
Emergent Technologies Inc. (ETI), founded in 1989 by Thomas A. Harlan, is a unique life sciences venture firm that forms and manages companies and funds that commercialize groundbreaking institutional and university-based technologies. ETI is a turnkey solution for converting university science into high return ventures. ETI works with regional economic development groups and universities to capitalize on the technology assets unique to their region. For more information, visit the company website www.etibio.com.
(a) Fund IV is not an affiliate of, nor has it been endorsed by, The University of Texas System.
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March 7, 2007
UT licenses drug technology to Austin startup
A news release from the University of Texas
The University of Texas at Austin announced today that it has licensed a drug delivery technology developed by the UT Austin team of Nicholas Peppas, Sc.D., Mark Byrne, Ph.D., and Zach Hilt, Ph.D., to Mimetic Solutions, LLC, an Emergent Technologies Fund IV portfolio company.
Dr. Peppas will serve as Co-Chief Scientist of Mimetic Solutions, along with Dr. Hilt, now on faculty at the University of Kentucky. Mimetic Solutions will be managed by Emergent Technologies, Inc., with Dr. Brian Windsor serving as Managing Director.
A pioneer in the field of drug delivery and smart-release systems, Dr. Nicholas Peppas has more than 30 years of research experience and has published more than 1,000 peer-reviewed articles and 30 books. He has made life-changing contributions to drug delivery and biomaterials applications using his recognized expertise in biomedical engineering and polymer chemistry.
Peppas, a member of both the National Academy of Engineering and the French Academy of Pharmacy, has received numerous awards for his multidisciplinary research. In addition to serving as Chief Scientist of Mimetic Solutions, Peppas will remain as the Fletcher Stuckey Pratt Chair in Engineering in the Departments of Chemical and Biomedical Engineering and Professor in the College of Pharmacy at the University of Texas at Austin.
“I have explored many academic areas of drug delivery and smart release chemistry, and am excited to apply this strong scientific foundation to some very important commercial applications,” notes Dr. Peppas.
“Emergent Technologies was planning a strategic initiative into the $100 billion drug delivery market, and we are excited to have joined with the leading scientist in this field, Dr. Peppas,” comments Thomas Harlan, President and CEO of ETI. ETI is a venture capital firm focused on early technology deals from universities with the goal of partnering with industry leaders to commercialize the technology.
Mimetic Solutions’ core technology, Affinimer™ Chemistry, allows for the creation of chemically engineered smart polymers that can bind specific “trigger” molecules such as a key biomarker in a patient’s blood and subsequently release a drug or other agent under pre-programmed conditions. Managing Director Brian Windsor commented, “Using our proprietary Affinimer™ chemistry we are currently pursuing two major applications: the TheraSmart™ System - smart release of therapeutic agents; and the BeautySmart™ System - smart cosmetic or cosmeceutical delivery.” A planned first application is a smart-release of insulin in response to blood glucose levels in diabetic patients.
ETI anticipates that the technology licensing deal is likely to be one of many to come. In a recent report from the Milken Institute, the University of Texas system was ranked first globally in the number of biotechnology patents filed.
“What we do over the next decade in the biotechnology field is crucial,” said Neil Iscoe, director of the Office of Technology Commercialization at Austin. “Universities must work closely with entrepreneurs, investors, and established industry to move nascent scientific discoveries into products that will bring significant value to society, addressing issues of health, productivity, and quality of life.”
Mimetic Solutions, LLC is a biopharmaceutical company pioneering new frontiers in drug and bioactive agent delivery. Beyond merely providing mechanisms for slower release or better compatibility, Mimetic Solutions is developing true smart release systems that sense the surrounding environment and deliver the right chemical or drug, at the right time and at the right dose. Using proprietary Affinimer™ chemistry, Mimetic Solutions creates biomimetic polymer networks that are engineered to release a payload chemical or drug under pre-defined conditions, such as upon binding of a specific biomarker or analyte. Mimetic Solutions seeks collaborative partnerships for development of many different commercial applications. To learn more about Mimetic Solutions, visit www.mimeticsolutions.com.
Emergent Technologies Fund IV, L.P., (Fund IV) has been established to invest in early-stage companies formed to commercialize technologies created, developed, owned, and/or synergistic with The University of Texas System.
Emergent Technologies Inc. (ETI) is a unique life sciences venture firm that forms and manages companies and funds that commercialize groundbreaking institutional and university-based technologies.
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December 15, 2006
Luminex to acquire molecular diagnostics company
A news release from Luminex Corp.:
Austin-based Luminex Corp. and Tm Bioscience Corporation today announced a definitive agreement for Luminex to acquire Tm Bioscience Corporation, a leader in the commercial genetic testing market. Under the terms of the agreement, each Tm Bioscience share will be exchanged for 0.06 shares of Luminex common stock. The per share consideration represents a 41.5 percent premium for Tm shares based on the closing price of a share of Tm common stock and Luminex common stock on December 14, 2006, the last trading day prior to the announcement of the acquisition. Upon completion of this transaction, Tm shareholders will own approximately 9 percent of Luminex outstanding common stock. Completion of the transaction is subject to the approval of Tm shareholders, required regulatory and court approvals, and certain other conditions set forth in the definitive agreement. The transaction is anticipated to close in the first quarter of 2007.
Based in Toronto, Ontario, Canada, Tm is a leading DNA-based diagnostics company developing a suite of molecular diagnostic tests. Tm’s products include tests for infectious diseases as well as tests for genetic mutations related to cystic fibrosis, sepsis, personalized medicine and other debilitating genetic disorders. Tm has proprietary technologies that improve the speed, accuracy, flexibility, and cost of DNA-based genetic tests. Tm’s cystic fibrosis test is the first multiplexed human disease genotyping test to be cleared by the U.S. Food and Drug Administration (FDA) for diagnostic use in the U.S. For the first nine months of 2006, Tm reported revenue of C$8.6 million, a 62% increase compared with C$5.3 million for the same period a year ago.
Commenting on the announcement, Patrick J. Balthrop, president and chief executive officer of Luminex, stated, “We believe that this transaction has the potential to be a transforming event for Luminex. We are very excited about the opportunity to bring the Tm products, capabilities and resources into our company and enhance our ability to be a leader in the growing molecular diagnostics market.
“As we previously announced, Luminex has been evaluating strategic acquisition candidates to advance our growth strategy. With Tm’s cGMP-capable manufacturing, proprietary molecular detection chemistries, assay development expertise and a strong menu of kits and reagents, and the complementary assets and strengths of Luminex’s partner-based business model, we intend to work closely with our business partners that have relevant distribution channels or complementary products to leverage this new business to the mutual benefit of Luminex and our partners. As we continue to support our partners in Life Science research and Immunoassay/HLA, molecular diagnostics will be an important growth market for Luminex. We believe this business combination will allow us to accelerate our growth strategy and build shareholder value.”
Commenting on the acquisition, Greg Hines, president and chief executive officer of Tm, stated, “After examining all of the options available to the company, we determined that the acquisition of Tm by Luminex was in the best interest of shareholders. During the six years that Luminex and Tm have worked together, we have become convinced that DNA-based diagnostics based on Tm’s Universal Array and Luminex’s xMAP can establish Luminex as a leader in the fast growing molecular diagnostics market. We believe that Luminex can secure the global reach and scale required to properly exploit Tm’s product portfolio. The proposed transaction will enable Tm shareholders to share in the growth of the combined business.”
J.P. Morgan Securities Inc. acted as exclusive financial advisor to Luminex in connection with this transaction. The investment banking firm Leerink Swann & Company (Boston, Massachusetts) acted as financial advisor to Tm in connection with the transaction and Westwind Partners (Toronto, Ontario) advised Tm with respect to financing for the transaction.
Management from both companies will host a conference call to discuss this announcement on Friday, December 15, 2006, at 8:00 a.m. Eastern time. The conference call will be webcast live and will be accompanied by a slide presentation, both of which may be accessed at Luminex Corporation’s website at http://www.luminexcorp.com or at Tm Bioscience’s website at http://www.tmbioscience.com . Simply log on to the web at the address above, go to the Company section and access the Investor Relations link. Please go to the website at least 15 minutes prior to the call to register, download and install any necessary audio/video software. If you are unable to participate during the live webcast, the call and slides will be archived for one year on the website using the ‘replay’ link.
About Tm Bioscience
Tm Bioscience is a Toronto-based diagnostics company developing a suite of DNA-based tests for genetic disorders, drug metabolism (pharmacogenetics) and infectious diseases. Tm Bioscience has developed and commercialized Analyte Specific Reagents* and a series of Tag-It(TM)** tests for a variety of genetic disorders. These tests are based on Tm Bioscience’s proprietary Tag-It(TM) Universal Array platform, which utilizes a proprietary universal tag system that allows for easy optimization, product development and expansion. Tm Bioscience’s ID-Tag(TM) Respiratory Viral Panel (RVP) is a reliable and cost- effective test designed to play a key role in patient management, infection control and in countering the pandemic threat of respiratory diseases, all with results in less than six hours. The ID-Tag(TM) RVP has received CE mark certification and the company is focused on gaining regulatory clearance from the FDA for the ID-Tag(TM) RVP as an in vitro device (IVD) in the United States. Tm Bioscience’s Cystic Fibrosis (CF) test is the first multiplexed human disease genotyping test to be cleared by the FDA as an in vitro device (IVD) for diagnostic use in the U.S. It has also received CE mark certification and Health Canada clearance, allowing the test to be marketed for diagnostic purposes in the European Union and Canada. In addition, the company is developing a companion test for the blood-thinning drug warfarin and a test for patients under treatment for sepsis.
About Luminex
Luminex Corporation develops, manufactures and markets proprietary biological testing technologies with applications throughout the life sciences industry. The company’s xMAP(R) system is an open-architecture, multi-analyte technology platform that delivers fast, accurate and cost-effective bioassay results to markets as diverse as pharmaceutical drug discovery, clinical diagnostics and biomedical research, including the genomics and proteomics research markets. The company’s xMAP(R) technology is sold worldwide and is in use in leading research laboratories as well as major pharmaceutical, diagnostic and biotechnology companies. Further information on Luminex Corporation or xMAP(R) can be obtained on the Internet at http://www.luminexcorp.com.
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November 15, 2006
Austin company clones top barrel-racing horse
A news release from ViaGen Inc.
Scamper, the legendary barrel racing horse owned by rodeo star Charmayne James, now has a young twin thanks to cloning company ViaGen. ViaGen and James announced today that Scamper’s clone Clayton was born in Texas on August 8th of this year.
James says she named the foal after her childhood home town of Clayton, New Mexico, where she met Scamper when she was 11 years old. Though Scamper was considered unrideable, James and her father admired the horse’s conformation, or physical form, so her father bought him from a cowboy who worked on his feedlot.
James trained Scamper, and in 1984 at age 14 she rode him to win the World Championship in Barrel Racing. The pair went on to win the next nine World Championships, making James the all-time leading money earner in Barrel Racing, the first million dollar cowgirl, and the holder of more world championships than any other woman in professional sports.
This year, James decided to clone the 29-year-old horse in order to continue to use his exceptional genetics in her breeding program. She hired ViaGen, the Austin, Texas-based world leader in animal cloning, to do the cloning work. A few months later Clayton was born in Boerne, Texas.
“If there was ever a horse to be cloned, Scamper’s the one,” said James. “The baby looks so much like Scamper, conformation-wise. He’s so balanced, he’s got the same shoulder, the same bright eye. I’m happy I had Scamper cloned and I’m so happy with the results.”
“We were honored but not surprised that Charmayne would seek to clone Scamper,” said ViaGen President Mark Walton. “Horse breeders increasingly recognize that cloning is an excellent tool for maximizing the value of their best genetics.”
Cloning produces a later-born identical twin, thereby preserving and multiplying the genetics of superior animals. Many horse breeders, who already use assisted reproductive techniques such as in vitro fertilization and embryo transfer, view cloning as the next step in breeding.
The technology can be used to produce stallions from the genes of top- performing geldings, or to produce duplicates of popular stallions so that their owners can keep up with demand for semen, embryos, and offspring.
ViaGen also offers a gene banking service, which enables people to preserve the genes of exceptional animals for possible later use in cloning, or as insurance against unexpected injury or loss.
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Austin company clones top barrel-racing horse
A news release from ViaGen Inc.
Scamper, the legendary barrel racing horse owned by rodeo star Charmayne James, now has a young twin thanks to cloning company ViaGen. ViaGen and James announced today that Scamper’s clone Clayton was born in Texas on August 8th of this year.
James says she named the foal after her childhood home town of Clayton, New Mexico, where she met Scamper when she was 11 years old. Though Scamper was considered unrideable, James and her father admired the horse’s conformation, or physical form, so her father bought him from a cowboy who worked on his feedlot.
James trained Scamper, and in 1984 at age 14 she rode him to win the World Championship in Barrel Racing. The pair went on to win the next nine World Championships, making James the all-time leading money earner in Barrel Racing, the first million dollar cowgirl, and the holder of more world championships than any other woman in professional sports.
This year, James decided to clone the 29-year-old horse in order to continue to use his exceptional genetics in her breeding program. She hired ViaGen, the Austin, Texas-based world leader in animal cloning, to do the cloning work. A few months later Clayton was born in Boerne, Texas.
“If there was ever a horse to be cloned, Scamper’s the one,” said James. “The baby looks so much like Scamper, conformation-wise. He’s so balanced, he’s got the same shoulder, the same bright eye. I’m happy I had Scamper cloned and I’m so happy with the results.”
“We were honored but not surprised that Charmayne would seek to clone Scamper,” said ViaGen President Mark Walton. “Horse breeders increasingly recognize that cloning is an excellent tool for maximizing the value of their best genetics.”
Cloning produces a later-born identical twin, thereby preserving and multiplying the genetics of superior animals. Many horse breeders, who already use assisted reproductive techniques such as in vitro fertilization and embryo transfer, view cloning as the next step in breeding.
The technology can be used to produce stallions from the genes of top- performing geldings, or to produce duplicates of popular stallions so that their owners can keep up with demand for semen, embryos, and offspring.
ViaGen also offers a gene banking service, which enables people to preserve the genes of exceptional animals for possible later use in cloning, or as insurance against unexpected injury or loss.
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September 7, 2006
Introgen cancer treatment gets orphan drug designation in Europe
A news release from Introgen Therapeutics Inc.
Gendux AB and Introgen Therapeutics, Inc. (NASDAQ:INGN) announced today Gendux was notified by the European Medicines Agency Committee for Orphan Medicinal Products that Advexin p53 therapy has received orphan medicinal product designation in Europe for the treatment of Li-Fraumeni Syndrome. LFS is a genetic disorder characterized by inherited mutations in the p53 tumor suppressor gene. EU orphan designation confers a number of regulatory benefits for the product, including access to protocol assistance, reduced regulatory fees and a 10-year period of marketing exclusivity from the date of approval. The designation recommended by the EMEA Committee for Orphan Medicinal Products must be ratified by the European Commission, and is expected within 30 days. Gendux is a wholly owned subsidiary of Introgen Therapeutics Inc.
Dr. Max W. Talbott, senior vice president of worldwide commercial development and regulatory affairs at both Introgen and Gendux said, “We are very encouraged by the recognition of the unique ability of ADVEXIN to treat the tumors of Li-Fraumeni Syndrome cancer patients without the toxicity that characterizes many other anti-cancer treatments. We plan to seek expedited registration of ADVEXIN in Europe utilizing the Exceptional Circumstances provisions of the EMEA’s registration rules. The European registration efforts compliment our advancing registration program in the United States and will provide for ADVEXIN’s availability in both major biopharmaceutical markets.”
Advexin is a targeted molecular therapy with broad applicability in a wide range of tumor types and clinical settings because it targets one of the most fundamental and common molecular defects, abnormal p53 tumor suppressor function, associated with cancer initiation, progression and treatment resistance.
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August 15, 2006
Luminex gets Homeland Security contract
News release from Luminex Corp.
Austin-based Luminex Corporation (NASDAQ:LMNX) , a leading multiplex solution developer, Tuesday announced that it has received a sub-contract from Smiths Detection, for research related to detecting acts of bio-terrorism. The company makes biological detection equipment.
Smiths Detection is a leading global provider of chemical, biological and explosives detectors and X-ray security screening equipment. The award comes from the Homeland Security Advanced Research Projects Agency as part of their Low-Cost Biological Agent Detection System program. In this program, Luminex will work as a sub-contractor to Smiths Detection to develop a very low-cost early warning trigger sensor to detect the presence of weaponized biological pathogens in the ambient air.
i”The ‘trigger’ sensor is designed to serve as the front end to a comprehensive bio-detection system, in which the trigger provides early warning of a possible attack, followed by a confirmatory sensor subsequently determining actual species identification,” said Patrick Balthrop, president and chief executive officer of Luminexn. “The Smiths team approach is to design and develop an optically-based trigger sensor, utilizing our corporate expertise in optical detection technologies to meet the very demanding cost, performance, and reliability goals set forth” in the program.
“We are very pleased to have been awarded the sub-contract through Smiths, providing Luminex with important opportunities to leverage our state-of-the art technology and increase our market awareness within the government sector,” added Balthrop. “This program demonstrates our strategy to offer total solutions to the government for defending against bio-terrorism. This opportunity will also make us more competitive for future research grants that utilize our systems and technology.”
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