Tuesday, January 5, 2010

Tengion plans $40 million IPO

Tengion plans $40 million IPO
December 28, 2009 by MassDevice staff

Tengion Inc. rides a late-year surge in initial public offering filings to launch a bid for $40 million in fresh funding for its organ and tissue regeneration process.
Tengion logo

Joining what is quickly becoming a mini-stampede toward the public markets, a suburban Philadelphia biotech unveiled plans for an initial public offering of stock.

The company, Tengion Inc. of East Norriton, Pa., is working to commercialize a process that coaxes the body into producing its own replacement organs. Early testing has demonstrated some success rebuilding bladder tissue in children with spina bifida and Tengion officials are now hoping that those encouraging results will attract sufficient market support to finance additional clinical trials.

According to its preliminary prospectus filed Dec. 23, the company expects to raise up to $40.25 million in gross proceeds from the IPO. Other terms for the offering are purposely left vague, although it's clear that a sizable portion of the deal will go to pay off $24.3 million in loans coming due by April 2012 and requiring up to 12.26 percent in yearly interest costs.

Existing investors, which include Boston's Bain Capital and Oak Investment Partners of Westport, Conn., obviously are also eager for an IPO to loosen money they've had tied up in Tengion since August 2005. Overall, venture funds and institutional investors have a total of $184.2 million invested in the company, including a $33 million Series C funding round completed in September, 2007, and a $50 million B-round in June, 2006.

Liquidity desires and a rebounding market, meanwhile, appear to be spurring a surge in IPO filings after a long dry spell. With a week left in the current quarter, 62 companies have filed plans for first-time offerings — representing more than half of the year's total and marking the strongest quarterly activity in nearly two years, according to data gathered by Renaissance Capital.

Neural tube birth defects on rise in Utah

Neural tube birth defects on rise in Utah
Salt Lake Tribune - Heather May

Thousands of Utah women are getting free bottles of multivitamins in the hopes that none of their future children will develop deadly but preventable neural tube defects.

The 26,000 bottles of vitamins, paid for by a federal grant and through a private donation by the group Vitamin Angels, contain 400 micrograms of folic acid. The B vitamin helps a fetal neural tube properly develop into the brain and spinal cord, according to the March of Dimes.

While the importance of folic acid was common knowledge a few years ago, fewer women know it now, according to the Utah Department of Health.

"We have a new cohort of women coming into this group every year ... who haven't heard this message," said Amy Nance, the Utah Birth Defect Network at the health department.

That may be why the number of Utah babies born with neural tube defects is on the rise. Up to 25 more babies were born in 2008 with defects like spina bifida or the deadly anencephaly (in which the brain fails to develop) than in the late-1990s.

Seventy percent of neural tube defects are preventable with the well-timed digestion of folic acid, according to the March of Dimes. The vitamin must be taken in the first few weeks of pregnancy when the neural tube is developing -- before women know they are pregnant.

Since one-third of Utah pregnancies are unintended, the health department is advocating all women of childbearing age take the supplement everyday.

It is using its grant money to focus on women in the federal Women, Infants and Children (WIC) program, which provides food vouchers and nutritional counseling.

The health department targeted WIC clients because they are an easy group to reach and their demographics also align with the mothers who have had babies with neural tube defects: Most are under age 30, and one-quarter are Latino, whose babies are up to two times more likely than others in the United States to have such a defect.

Since October, WIC offices in Box Elder, Cache, Rich, Salt Lake, Tooele and Wasatch counties have been giving out a 3-month supply of multivitamins to women who had had a baby six weeks before. One in five pregnancies in Utah occur within 15 months of a prior birth; 5 percent within 6 months.

The WIC offices also have a new DVD on folic acid to play in their waiting rooms, to target all women using WIC services.

hmay@sltrib.com

Xiao to visit Mumbai to treat spina bifida patients

Xiao to visit Mumbai to treat spina bifida patients
India Today - Nishat Bari - ‎Dec 28, 2009

Dr. Chuanguo Xiao of China has developed a nerve re-routing surgical procedure to treat patients suffering from Spina bifida, a disorder of the spine, as well as other related spinal injury disorders. He had been invited to Mumbai for a week by Kokilaben Dhirubhai Ambani Hospital to conduct the surgery on patients as well as train doctors about the procedure.

Spina bifida is a congenital defect where the patient has no sensation or control of his bladder or bowels. Though people have this defect since birth, spinal injuries can also lead to the condition. Patients are dependent on diapers or catheter (a tube inserted into the bladder to drain bodily fluids) to cope with the condition and there is no other treatment for it.

Xiao has successfully treated the condition in over 1500 patients by re-routing the nerves from the bladder and bowels to the thighs. This is done using a part of a nerve from the patient's leg. The result is that the patient can activate his bladder or bowels on his own by scratching a spot on his thigh.

He has conducted 8 successful surgeries at Ambani Hospital with the help of a core team, comprising of Dr. Amrish Vaidya, Dr. Ketan Parikh, Dr. Abhaya Kumar and Dr. Poornima Shah. The surgeries have been sponsored by the hospital and the cost of the procedure is expected to be ascertained within 2-3 weeks. The hospital already has a long list of people who have enlisted for the surgery. In the US the surgery costs $45,000.

It takes about 5-6 months after the surgery for the nerves to grow before a result can be seen. In certain cases it can take almost 2 years before a change is noticed. The success of the surgery varies if the patient has undergone prior surgeries on the spine. In such cases the nerves have already been weakened by surgery and can take longer to grow. Xiao says that if the Xiao Procedure is carried out at an early age, the patient can even regain sensation of the bladder and bowels.

Xiao has been researching the procedure for the last 10 years, the first 8 on animals. He performed the first surgery on a person in China in 1995. In some of his first patients he noted a slight weakness in the patient's leg post the surgery. This was because he would use a whole nerve from the leg for the procedure. However, he has modified the technique and now uses only half or one third of the nerve, and says there are no side effects of the procedure.

Xiao is a professor and Chairman of the Department of Urology at Union Hospital, Tongji Medical College in China. He became interested in treatments for spinal injuries while he was a resident doctor at Hubei Medical College in China in 1976 when a huge earthquake killed thousands of people. Many of the victims suffered from spinal injuries. He has performed surgeries in several countries including USA, Germany, Denmark, Australia, and has been invited by several more including Philippines, Canada and Japan.

There are 80,000 new cases of Spina bifida in China each year. In India there are 25000 to 30000 new cases a year, or 5-7 cases per 1000 births. It can be diagnosed at birth as the children born with it have a lesion on the lower back.

Accidental Discovery Advances Understanding of Spinal Cord Birth Defects

Accidental Discovery Advances Understanding of Spinal Cord Birth Defects
http://www.brainandspinalcord.org/blog/2010/01/04/accidental-discovery-advances-understanding-of-spinal-cord-birth-defects/

A report published in the December 6 issue of the journal Nature Cell Biology revealed a link between certain genetic mutations and early development of spinal cord disorders in mice. Scientists from the Johns Hopkins University School of Medicine and the University of California-Berkeley made the accidental discovery while searching for genes that guide the development and routing of the billions of neurons that make up the nervous systems of mice.

The study initially involved creating random mutations in mouse genes and then studying the offspring for nervous system defects. While examining thousands of mouse embryos as part of the study, graduate student Janna Merte noticed one of them had a spinal cord that had failed to develop from a flat sheet of cells into a tube.

Healthy spinal cord cells in mouse embryos develop at first in a flat layer of cells which then rolls up into a tube to begin forming the spinal cord. In spina bifida and other spinal cord disorders, the flat layer of cells never rolls up into a tube.

The mutated gene in the mouse embryo with the ill-developed spinal cord was identified by Merte as Sec24b, a gene already known to influence the process by which cells package proteins for the cell membrane or for delivery outside of the cell. The Johns Hopkins researchers then brought in Randy Schekman, the Berkeley professor who first discovered the Sec24 gene in yeast.

The team investigated another gene that, when mutated, led to similar problems with spinal cell tube closure in mice. The researchers discovered that the gene, known as Vangl2, was influenced by the presence of Sec24b. Further examination suggested that mutations in Sec24b and Vangl2 could be closely related to the development of spinal cord defects in humans.

Sixty-eight percent of mice engineered with mutations in both Sec24b and Vangl2 were born with spina bifida, which suggested to the scientists an integral interaction between the two genes.

Sec24b was found to be instrumental in spinal cord cells’ ability to properly package Vangl2. Mutations in either of the genes led to similar spinal cord defects in the animal models. The researchers’ discovery has opened the door to further studies in humans, which could lead to great advances in the understanding, prevention, and treatment of patients with spina bifida and other spinal cord disorders.

References:

Johns Hopkins Medical Institutions. (December 28, 2009) “One Step Closer to Closure: Neuroscientists Discover Key to Spinal Cord Defects.” Retrieved December 29, 2009 from the Science Daily website: http://www.sciencedaily.com/releases/2009/12/091228090543.htm

Tuesday, November 3, 2009

CDC Study Links 2 Antibiotics to Birth Defects

CDC Study Links 2 Antibiotics to Birth Defects
No added risk was found, however, for most commonly used infection-fighters
Posted November 2, 2009

By Jennifer Thomas
HealthDay Reporter

MONDAY, Nov. 2 (HealthDay News) -- Taking antibiotics during pregnancy does not raise the risk for most birth defects, though there are some exceptions, new research has found.

Penicillin, which is the most commonly used antibiotic during pregnancy, as well as erythromycin, cephalosporins and quinolones, other widely prescribed antibiotics, were not associated with increased risk for about 30 different birth defects.

However, the study found that two types of antibiotics were linked with a higher risk for several birth defects: nitrofurantoins and sulfonamides, sometimes called "sulfa drugs," which are prescribed for urinary tract and other infections.

Women whose children had anencephaly, a fatal malformation of the skull and brain, were three times more likely to have taken sulfonamides, the study found. Sulfonamides were also tied to an increased risk for such heart defects as hypoplastic left heart syndrome and coarctation of the aorta, choanal atresia (a blockage of the nasal passage), transverse limb deficiency and diaphragmatic hernia, an abnormal opening in the diaphragm that results in severe breathing difficulties.

Nitrofurantoins were also associated with multiple birth defects, including anophthalmia and microphthalmos (eye defects) and several congenital heart defects. Mothers whose children were born with a cleft lip or cleft palate were twice as likely to have taken nitrofurantoins, the study found.

But pregnant women should not be overly worried if they need an antibiotic to treat an infection during pregnancy, stressed the study's lead author, Krista Crider, a geneticist with the National Center on Birth Defects and Developmental Disabilities, part of the U.S. Centers for Disease Control and Prevention.

"The most important message is that most commonly used antibiotics do not seem to be associated with the birth defects we studied," Crider said.

The findings are published in the November issue of Archives of Pediatrics & Adolescent Medicine.

Crider and her colleagues analyzed data on more than 13,000 women whose babies had one of more than 30 birth defects, including cleft palate, heart or limb defects and anencephaly. They compared the women's rates of antibiotic usage, from the month leading up to pregnancy through the end of the first trimester, with that of almost 5,000 women whose children did not have a birth defect. The data was culled from the National Birth Defects Prevention Study, which began in 1997 and includes about 30,000 women from 10 states.

Information on the impact of many prescription drugs on developing fetuses is sorely lacking, Crider pointed out. Much of that stems from the fact that ethical considerations preclude conducting drugs trials in pregnant women, she said.

Though many antibiotics have been used safely for decades, resistant strains of bacteria are forcing doctors to use a wider array of antibiotics. For some, little data exist.

The researchers found that about 30 percent of women took an antibiotic between the three months prior to conception and the end of the pregnancy.

Even antibiotics that generally were safe were found to be associated with a few specific birth defects. Women whose babies were born with a certain type of limb malformation were three times more likely to have taken penicillin. Erythromycin, cephalosporins and quinolones were also associated with an increased risk for one or two specific birth defects.

However, the researchers said they did not know if the birth defects were caused by the antibiotics or the underlying infection.

One expert said women need to remember the good antibiotics can do mom and baby, as well. Though many pregnant women want to avoid taking any drugs during pregnancy, infections pose a risk to mother and baby and often need to be treated, said Dr. Jennifer Wu, an obstetrician-gynecologist at Lenox Hill Hospital in New York City.

"Untreated infections during pregnancy can lead to severe consequences, such as maternal sepsis [blood infection] and preterm labor," Wu said. "Yet many patients are afraid to take medications such as antibiotics during pregnancy."

The study "supports the evidence that antibiotics are safe for pregnant women," she said. "It is reassuring for doctors and patients to have more data on necessary drugs for pregnancy."

Crider also stressed that the chances of having a baby with a birth defect remain small, even if an antibiotic has been linked to an elevated risk. For example, the risk of having a child with hypoplastic left heart syndrome is about one in 4,200. Sulfonamides were associated with a three-fold increase, making the likelihood about one in 1,400, she said.

Brand names for nitrofurantoins include Furadantin, Macrobid and Macrodantin. Bactrim and Septra are among the brand names of sulfonamides.

Given the data, Crider said, women should be cautious about taking either of those types of drugs during pregnancy and should discuss other options with their physicians,.

According to the study, the overall risk for having a child with a birth defect is about three percent.

The study did not look at chromosomal defects, including Down syndrome.

Monday, September 14, 2009

VitaPath gets $6M to fight spina bifida

VitaPath gets $6M to fight spina bifida

VitaPath Genetics, developer of a diagnostic that could be used to lessen rates of the birth defect spina bifida, has raised $6 million in a first round of funding led by Mohr Davidow Ventures. The money should provide the Foster City, Calif. with runway through next year, covering testing for women with a high chance of having a baby with spina bifida.

The condition, which causes a underdeveloped spinal column often leading to nerve and brain damage, occurs in eight babies born every day. VitaPath’s mission is to identify women at high risk for the defect before they even conceive. Those who are can potentially fix the problem by taking high amounts of folic acid.

X/Seed Capital Management also participated in the financing. It previously provided see money which was rolled into the round.

Wednesday, August 19, 2009

Low Choline Level in Pregnancy Tied to Birth Defects

Low Choline Level in Pregnancy Tied to Birth Defects
Anencephaly, spina bifida linked to nutrient found in foods, study shows
Posted August 14, 2009

FRIDAY, Aug. 14 (HealthDay News) -- Low blood levels of the nutrient choline during pregnancy increases the risk of brain and spinal-cord defects in newborns, U.S. researchers report.

They focused on two types of neural tube birth defects -- anencephaly and spina bifida. Anencephaly is a lethal condition in which the brain and skull don't develop, and spina bifida is a spinal-cord malformation that causes paralysis and lifelong disability.

The Stanford University School of Medicine team compared pregnancy blood samples from 80 women who gave birth to children with anencephaly and spina bifida to pregnancy blood samples from 409 women whose infants had no birth defects.

The results showed that choline levels were linked to risk of neural tube defects. Choline is found in egg yolks, soy, wheat germ and meats.

Women with the lowest blood choline levels during pregnancy were 2.4 times more likely to have infants with neural tube defects than women with average blood choline levels. Women with the highest choline levels had the lowest risk.

The study appears in the Aug. 14 issue of Epidemiology.

Primary author Gary Shaw, a professor of neonatology, noted that prenatal vitamins contain little or no choline. For women planning to get pregnant, "the best source for choline is still eating a variety of foods," he said in a university news release.

More information

The U.S. National Institute of Child Health and Human Development has more about neural tube defects.