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VGXI Expands Manufacturing Facility, Adds Key Personnel

noemail@biohouston.org — Tue, 09 Mar 2010 17:00:00 GMT

NEW ORLEANS--(BUSINESS WIRE)--Mar 4, 2010 - VGXI, Inc., a leading provider of DNA plasmid manufacturing and development services, announced today at the 2010 DNA Vaccines Conference the expansion of its state-of-the-art cGMP plasmid manufacturing facility in The Woodlands, TX. This expansion nearly doubles the size of our current facility putting us in a much better position to meet the growing demand for our research and cGMP manufacturing services, said Henry Hebel, COO. While at the conference, Mr. Hebel will present a talk entitled Developing a Successful Contract Manufacturing Organization Partnership: A Case Study where he will discuss what to expect from a CMO and present examples of challenging projects successfully completed by VGXI. The Company also announced the addition of DNA vaccine pioneer, Dr. David Weiner, Ph.D., to VGXI's Scientific Advisory Board. Dr. Weiner currently serves as the Chairman of Inovio Biomedical's Scientific Advisory Board and as a Professor of...

Lexicon to put $95M in shares on sales block

noemail@biohouston.org — Mon, 08 Mar 2010 17:00:00 GMT

Lexicon Pharmaceuticals Inc.'s shares slid 9 percent Monday after the biopharmaceutical firm announced plans to offer $95 million of its stock to the public.

Lexicon (NASDAQ: LXRX) has granted underwriters up to $14.25 million in shares to cover any over-allotments.

The Woodlands company’s shares closed March 5 at $1.78 per share. It has 175.7 million shares outstanding.

Morgan Stanley & Co. Inc. and J.P. Morgan Securities Inc. will be acting as joint book-runners for the offering, with Cowen and Co. LLC and Thomas Weisel Partners LLC acting as co-managers.

Based on the $1.78 closing price, the company could sell as many as 61.4 million shares, including the over-allotment. That would be nearly 35 percent of its 175.7 million shares outstanding.

Shares of Lexicon were trading down 16 cents at $1.62 by Monday afternoon, after having dropped as low as $1.57 earlier in the day. The stock has traded between 89 cents and $3.78 in the past year.

UTSA opens New Venture Incubator on campus

noemail@biohouston.org — Mon, 08 Mar 2010 17:00:00 GMT

The University of Texas at San Antonio has opened a new facility on campus that will offer office and laboratory space to technology entrepreneurs as a way to help them grow their companies.

The UTSA Center for Innovation and Technology Entrepreneurship opened up the New Venture Incubator as part of its ongoing efforts to foster the development of more home-grown tech firms. The New Venture Incubator is located on UTSA’s Main Campus and is managed by the Center for Innovation and Technology Enterpreneurship. UTSA’s College of Engineering and College of Business founded the Center for Innovation and Technology Enterpreneurship back in 2007.

Pharmaceutical company ViroXis Corp. will be the first business to occupy space in UTSA’s incubator facility. ViroXis is working to identify and patent botanically-derived compounds that can be used in infectious disease treatments as well as cancer therapies. Over the next two to three years, ViroXis will work to develop a cost-effective and proven botanical drug that will target the human papilloma virus (HPV). The virus causes skin and genital wart infections and is the leading cause of cervical cancer. Some 20 million people in the United States between the ages of 15 and 49 become infected with HPV.

“By working with promising new companies that are aligned with the university’s research strengths, we create a win-win partnership that benefits the university through increased research funding and IP licenses while providing start-ups with connections to the support they need to become successful free-standing enterprises,” says Cory Hallam, director of the UTSA Center for Innovation and Technology Enterpreneurship.

UTSA is working to become a national research university. The university has 29,000 students.

KCI gains approval to expand to Japanese wound-care market

noemail@biohouston.org — Mon, 08 Mar 2010 16:00:00 GMT

Japanese health insurance regulators have approved Kinetic Concepts Inc.’s wound-care system for reimbursement.

Japanese physicians who prescribe the company’s V.A.C. Therapy System, will be able to get reimbursed by the government. This move by the government clears the way for Kinetic Concepts (KCI) to have its products sold in Japan.

With this approval in hand from Japan’s Health Insurance Bureau, KCI expects to begin selling the product in Japan in April. Japan’s Ministry of Health, Labor and Welfare already granted final regulatory approval for the product back in November.

“Japan represents a very important and underserved market for advanced wound care,” says Catherine Burzik, KCI’s president and CEO. “The people of KCI are committed to helping physicians and nurses improve the lives of wound care patients in Japan.”

V.A.C. Therapy has been used to treat more than 3 million patients worldwide.

San Antonio-based KCI (NYSE: KCI) is a global medical technology company that manufactures and markets products for the wound care, tissue regeneration and therapeutic support systems markets. The company markets its products in more than 20 countries.

Stem Cell Innovations to Provide Research and Assay Services to Agennix Read more: http://www.fiercebiotech.com/press-releases/stem-cell-innovations-provide-research-and-assay-services-agennix-0#ixzz

noemail@biohouston.org — Wed, 03 Mar 2010 19:15:00 GMT

HOUSTON, March 2 /PRNewswire-FirstCall/ -- Stem Cell Innovations (Pink Sheets: SCLL) announced today that the Company has signed a Master Services Agreement to provide research and assay services in support of Agennix's talactoferrin program. The assay utilizes SCLL's C3A human liver cell line. We are happy to enter into this contract with Agennix, said James H. Kelly, PhD, CEO of Stem Cell Innovations. Our C3A cells provide a reliable and reproducible foundation on which to base the talactoferrin assays. In addition to the talactoferrin assays, SCLL will provide other research and cell culture services to Agennix. About Agennix Agennix AG is a publicly traded biopharmaceutical company that is developing novel therapies in areas of major unmet medical need to improve the length and quality of life of seriously ill patients. The Company's most advanced program is talactoferrin, an oral targeted therapy that has demonstrated activity in randomized, double-blind, placebo-controlled...

Vidacare unveils bone marrow extraction device in U.S.

noemail@biohouston.org — Wed, 03 Mar 2010 19:00:00 GMT

Vidacare Corp. has released its OnControl Bone Marrow System.

The company developed this system with an eye toward raising the standard of care for bone marrow patients, while alleviating much of the pain of traditional procedures.

Vidacare officials developed its system using its patented lithium battery-power driver. The OnControl Bone Marrow System is designed to quickly drill a needle directly into the marrow of a patient and extract enough marrow for either an aspiration or a biopsy. Aspirations involve doctors removing small amounts of bone marrow tissue from a patient’s body. A bone marrow biopsy involves doctors removing a portion of the bone.

Traditional bone marrow procedures rely upon a manual device hand-inserted into the patient. This procedure can take anywhere from 2 minutes to 30 minutes to collect a biopsy.

With Vidacare’s OnControl Bone Marrow System, the median time is 81 seconds, according to clinical studies.

Prior to full-scale launch, Vidacare worked with 31 clinicians at 13 sites to evaluate the product.

Founded in 2001, San Antonio-based Vidacare develops, manufactures and markets advanced technologies that allow doctors to drill through bones.

The company’s EZ-IO device helps doctors gain emergency access to a patient’s vascular system when traditional IV access is not available. Vidacare’s bone marrow device allows doctors to perform aspirations and biopsies.

Mission Pharmacal rolls out new product to help alleviate morning sickness

noemail@biohouston.org — Mon, 01 Mar 2010 19:00:00 GMT

Mission Pharmacal Co. has developed a new vitamin supplement designed to help reduce the amount of morning sickness women face during pregnancy. The San Antonio company created a new B6-rich prescription prenatal vitamin, called CitraNatal B-Calm. It’s designed to boost a woman’s defense system against pregnancy-related nausea and vomiting. The scientific literature from the American College of Obstetricians and Gynecologists suggests that vitamin B6 supplements may be helpful to women who face severe forms of nausea during pregnancy. “For many women, pregnancy-related nausea and vomiting can be a serious concern,” says Mission Pharmacal President Neill Walsdorf, Jr. “We are pleased to offer women a prenatal vitamin option that may help provide some relief during their pregnancies.” As many as 85 percent of pregnant women may experience nausea and up to half may experience vomiting early during their pregnancies. There is no...

A&M gets big grant to make tobacco-based vaccine

noemail@biohouston.org — Wed, 24 Feb 2010 19:45:00 GMT

The Texas A&M University System and a Texas company have been awarded a $40 million U.S. Department of Defense grant to develop vaccines made from tobacco, a hoped-for improvement on the antiquated egg-based technology that made the response to last year's swine flu outbreak so slow. The so-called Texas Plant-Expressed Vaccine Consortium announced the manufacturing initiative Wednesday. It will be headquartered in a 145,000-square-foot facility to be built on 21 acres at the Texas A&M Health Science Center in Bryan. “If this works, we'll have a billion-dose-per-month vaccine facility in Texas, which would be by far the largest and most capable center in the world,” said Brett Giroir, vice chancellor for research for the A&M System and co-principal investigator for the project. “It would have staggering economic implications for the state of Texas, as well as overwhelming health implications for the nation and world.” Giroir said the consortium hopes to have...

MicroTransponder Inc. raises $7M

noemail@biohouston.org — Wed, 24 Feb 2010 19:00:00 GMT

Medical device developer MicroTransponder Inc. raised $7 million Series B round financing for its next clinical trial, according to a press release today.

The Austin company is testing a wireless neurostimulation platform that will treat chronic pain and other neurological indications. MicroTransponder did not name the investors, but said the latest contribution came from existing funders and angel investors.

At the same time, the company said it was awarded a $2.6 million grant that will pay for pre-clinical device validation. MicroTransponder used the funds to hire clinical and support staff to test the SAINT System.

Cyberonics approves share buyback program

noemail@biohouston.org — Thu, 18 Feb 2010 22:00:00 GMT

The board of Cyberonics Inc. has approved a new share repurchase program of up to 1 million shares.

This replaces an older buyback program of 1 million shares. The Houston medical technology company repurchased 515,000 shares under the program.

Cyberonics (NASDAQ: CYBX) expects to complete this program by the end of fiscal 2011.

The company has about 27.7 million shares outstanding.

Mission Pharmacal retools kidney stone drug

noemail@biohouston.org — Wed, 17 Feb 2010 21:00:00 GMT

Mission Pharmacal Co. has developed a new formulation of its drug compound for kidney stone treatment.

The San Antonio company’s new Urocit-K 15 mEq extended-release tablet has been developed with a maximum-strength alkalinizing agent that has been shown to help prevent kidney stone recurrence in more than 90 percent of patients.

“The availability of Urocit-K 15 mEq is important for kidney stone patients because it can help ease their pill burden,” says David S. Goldfarb, clinical chief of nephrology at New York University Langone Medical Center and at New York Harbor Veterans Affairs Medical Center. “Therefore, this new dosage regimen may help patients to comply with their treatment regimens and, ultimately, help keep new kidney stones from forming.”

One in 10 people will have a kidney stone at some point in their lives. Once a person develops a kidney stone, that person is more likely to develop additional stones in the future.

Mission Pharmacal is a privately held pharmaceutical company.

Stematix inks deal with Argentine firm

noemail@biohouston.org — Mon, 15 Feb 2010 17:15:00 GMT

Stematix Inc. has signed a 10-year agreement with Laboratorios Bagó to distribute certain Stematix products.

Financial terms of the deal were not disclosed, however Houston-based Stematix has the option of additional forms of joint collaboration in clinical trials and treatments with Laboratorios Bagó, a medical products company based in Buenos Aires, Argentina.

As part of the deal, Laboratorios Bagó will distribute a variety of Stematix orthopedic and cellular products for use in regenerative and related medical treatments.

Luminex Corp. reports record growth

noemail@biohouston.org — Fri, 05 Feb 2010 17:00:00 GMT

Testing equipment maker Luminex Corp. reported $20 million in fourth quarter income on $38.1 million in revenue, which compares with $2 million in income on $28.1 million in revenue the same period last year.

Austin-based Luminex (Nasdaq:LMNX) reported that the 35 percent year-to-year revenue growth was the highest ever logged by the company.

Luminex, which was founded in 1995, employs about 380 workers. The company develops biological testing technologies with applications for the diagnostic and life sciences industries.

Luminex also posted $17.7 million in income on $120.6 million in revenue during fiscal 2009 versus $3 million in income on $104.4 million in revenue during the previous year.

In September 2009, the company received clearance from the U.S. Food and Drug Administration for a new cystic fibrosis test. In June 2009, Luminex launched two new cystic fibrosis tests in Europe.

GenSpera awarded patent for prospective prostate cancer drug

noemail@biohouston.org — Tue, 02 Feb 2010 17:00:00 GMT

The U.S. Patent and Trademark Office issued a new patent to GenSpera Inc. to cover the intellectual property on the company’s second anti-cancer drug compound currently in development.

The patent 7,635,682 covers GenSpera’s drug G-115 — which is activated in prostate tumors by an enzyme. In preclinical testing, G-115 was shown to inhibit the growth of tumors in animal models of prostate cancer. Obtaining the patent rights to this drug is key as GenSpera seeks formal Food and Drug Administration approval.

GenSpera’s President and CEO Craig Dionne says that the term of the patent will extend into 2026. This will give the company time to enter into discussions with future development partners.

San Antonio-based GenSpera is a development stage oncology company with a technology platform that delivers drugs directly into tumors.

Repros Therapeutics gets verbal OK for drug trial

noemail@biohouston.org — Tue, 02 Feb 2010 17:00:00 GMT

Repros Therapeutics Inc. has been given a verbal go-ahead from the U.S. Food and Drug Administration to initiate its investigational new drug application for the study of its male infertility drug Androxal in the treatment of men with Type II diabetes.

The Woodlands-based Repros (NASDAQ: RPRX) plans to enroll a total of 60 men into Phase IIa clinical trials to compare the reactions to a placebo to two active doses of the drug.

Dr. Glenn Cunningham, a professor at Baylor College of Medicine, will lead the trials.

Androxal is being developed for the treatment of secondary hypogonadism, or a defect of the gonads that results in the underproduction of testosterone.

Repros Chief Executive Officer Joseph Podolski said that the company must raise additional capital before it can actually move forward with the study. The company faced bankruptcy last year as its cash position dwindled.

Previous studies had found that men taking Androxal were more susceptible to hypoglycemia.

“The retrospective analysis from our previous study is interesting. However we should not underestimate the challenges in conducting studies in diabetes,” Podolski said. “We believe the protocol we have designed will determine if there is clinically significant signal that warrants further development.”

Last week, Repros received advice from the FDA on how to advance Androxal’s regulatory process.

Beckman Coulter to shutter Webster facility

noemail@biohouston.org — Mon, 01 Feb 2010 17:00:00 GMT

Beckman Coulter Inc. is closing its facility in Webster and laying off 19 people over the next few months.

In a letter to the Texas Workforce Commission, Beckman Coulter (NYSE: BEC) said the facility will close around Oct. 10. Between now and then, the Brea, Calif.-based biomedical testing company does expect more layoffs although it did not specifically state how many.

Many of the people being let go in this round, either on March 31 or April 15, are scientists or technicians. Beckman Coulter also laid off 11 people at the facility last November.

At the time, the facility, located at 445 Medical Center Blvd., employed 92 regular employees and five temporary employees.

Beckman Coulter’s customers include hospital laboratories, pharmaceutical and biotechnology companies, universities, medical schools and research institutions.

AirStrip names executive to lead product sales

noemail@biohouston.org — Mon, 01 Feb 2010 17:00:00 GMT

Health technology company AirStrip Technologies has hired a new chief sales officer to drive sales of its remote patient monitoring products.

Bruce Brandes comes to AirStrip from HealthStream Inc., where he was vice president of sales and field operations. HealthStream is a software-as-a-service health care company.

“Bruce knows the health care industry inside and out, and is especially skilled at building both sales infrastructure and strategic alliances with clients and partners,” AirStrip President Cameron Powell says. “Bruce will be a valuable asset as AirStrip’s usage numbers continue to rise in the U.S. and we move toward global availability.”

AirStrip developed a remote patient monitoring system called AirStrip OB that doctors are using to monitor the health of expectant mothers and their babies. The system can track info such as fetal heart rates and contractions through a mobile smart phone.

Pioneer Surgical Technology opening Austin office

noemail@biohouston.org — Fri, 29 Jan 2010 17:00:00 GMT

A Michigan-based medical device company will open an Austin facility in April, officials said this morning.

Pioneer Surgical Technology Inc. did not say how many jobs would be created or where the local office would be, but it will house its spine development division. Officials said they chose Austin because of the city's rich access to key spine markets and surgical support.

Central Texas has several prominent spine resources including Seton's Brain & Spine Institute, St. David's Physical Therapy & Spine Center, The Spine Recovery Center at University Medical Center Brackenridge and others.

The facility will open April 1.

Pioneer currently operates offices in Raleigh and Greenville, N.C.; Woburn, Mass.; and the Netherlands. The company was founded in 1992 and employs 270 worldwide. It acquired 120 U.S. and foreign patents and has numerous pending.

GenSpera enrolls first patient in cancer trial

noemail@biohouston.org — Thu, 28 Jan 2010 17:00:00 GMT

GenSpera Inc. has reached a milestone in the development of its investigational cancer drug.

In a phase 1 clinical study, doctors at the University of Wisconsin Carbone Cancer Center in Madison treated the first patient with GenSpera’s cancer chemotherapeutic agent G-202.

The phase 1 clinical study is designed to treat up to 30 patients with cancers that have progressed even after treatment with other anti-cancer therapies. The study will determine the safety, tolerability and effect the drug has on the human body. Researchers will also study how effective the drug is in treating solid tumors.

G-202 is designed to target the blood vessels in solid tumors in order to destroy the tumor’s blood supply.

San Antonio-based GenSpera is a development stage oncology company.

Repros shares spike after FDA meeting

noemail@biohouston.org — Wed, 27 Jan 2010 17:00:00 GMT

Repros Therapeutics Inc.’s shares soared Wednesday afternoon as the biopharmaceutical company received advice from the Food and Drug Administration on how to deal with its male infertility drug Androxal.

At the highest, Repros’ shares were up 77 percent to $1.22 from Jan. 26’s close of 69 cents. Shares closed Wednesday above 90 cents. The stock has traded as high as $11.35 in the past year.

In a meeting with the company, regulators asked The Woodlands-based Repros (NASDAQ: RPRX) to propose a label that better defines the population of individuals who will benefit from the use of Androxal. Repros had previously tried to get a label suggesting the drug would be suitable for men with secondary hypogonadism wishing to preserve their fertility.

Androxal is being developed for the treatment of secondary hypogonadism, or a defect of the gonads that results in the underproduction of testosterone.

The company was also asked by the FDA to conduct a literature review of the incidence of infertility associated with the use of exogenous testosterone as support of the company’s data.

During the meeting, Repros said it can clearly define the intended patient population who will benefit from the use of Androxal and provide the FDA with existing scientific citations that support the notion that exogenous testosterone impairs male fertility.

If the submitted data is approved, no additional meeting regarding the label may be required, according to Repros, and the FDA is promising a “timely response.”

So far, the new year has been good to Repros. On Jan. 15, the company was given the green light to begin trading on the NASDAQ Capital Market. Repros faced bankruptcy last year as its cash position dwindled.