GTx, Inc. (Nasdaq: GTXI) announced that the United States Food and Drug Administration has accepted for filing and review the New Drug Application (NDA) for toremifene 80 mg, an oral selective estrogen receptor modulator, which GTx seeks to market for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy (ADT).

The NDA is supported by results from a two year, double blind, placebo controlled, randomized Phase III clinical trial of 1,382 men with advanced prostate cancer on ADT.

GTx expects to hear within several weeks whether the NDA will receive priority or standard review.

About Prostate Cancer

Prostate cancer is the second most common type of cancer diagnosed in men in the U.S. An estimated 186,000 new cases of prostate cancer were diagnosed in the U.S. in 2008.

About ADT

ADT, primary treatment for advanced prostate cancer, has improved survival in men with prostate cancer. Approximately 700,000 men with prostate cancer are being treated with ADT and an estimated 100,000 are anticipated to initiate ADT each year.

ADT works by reducing testosterone to castrate levels. Testosterone, through the process of aromatization, is converted to estrogen. Healthy elderly men actually have higher levels of estrogen than do postmenopausal women. Because ADT reduces testosterone levels by up to 95%, it also substantially depletes estrogen levels.

Although estrogen is commonly thought of as a female sex hormone, it plays a critical role in men's health. Estradiol is the primary hormone responsible for bone turnover and bone quality. It is also important for cognition and the regulation of certain central nervous system functions and metabolism. Depletion of estrogen can result in serious side effects of ADT, including a high risk of bone fractures, adverse lipid changes and increased risk of cardiovascular disease, as well as common symptomatic side effects such as growth of breast tissue often accompanied by tenderness and pain, and hot flashes.

Of patients on ADT, up to 77 percent develop significant bone loss, making them susceptible to fracture. Recent studies indicate that the annual risk of fracture in men on ADT is 5% to 8%, or three times higher than the risk of fracture for postmenopausal women. Fractures are serious and can reduce survival in men on ADT by more than three years.

About GTx

GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways to treat cancer, osteoporosis and bone loss, muscle loss and other serious medical conditions. GTx is developing toremifene citrate, a selective estrogen receptor modulator, or SERM, in two separate clinical programs in men: first, a completed pivotal Phase III clinical trial evaluating toremifene 80 mg for the prevention of bone fractures and treatment of other estrogen side effects in men with prostate cancer on androgen deprivation therapy, and second, an ongoing pivotal Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia, or PIN. In 2006, GTx and Ipsen entered into a development and collaboration agreement for toremifene citrate in all indications except breast cancer for Europe and the Commonwealth of Independent States (CIS). GTx has submitted a NDA for toremifene 80 mg for the prevention of bone fractures in men with prostate cancer on ADT and, if approved, plans to commercialize toremifene 80 mg in the United States. In December 2007, GTx and Merck formed a collaboration to discover and develop selective androgen receptor modulators, or SARMs, a new class of drugs with the potential to treat sarcopenia, which is the loss of skeletal muscle mass resulting in reduced physical strength and ability to perform activities of daily living, as well as cancer cachexia (cancer induced muscle loss) and other musculoskeletal wasting conditions. Merck and GTx are evaluating multiple SARM product candidates, including Ostarine™ (designated by Merck as MK-2866) for sarcopenia in several Phase I and II clinical development programs. Merck and GTx are evaluating additional muscle loss indications including cancer cachexia for potential SARM clinical development. GTx also is developing its preclinical compound GTx-758, an oral luteinizing hormone inhibitor, for advanced prostate cancer. http://www.gtxinc.com

Forward-Looking Information is Subject to Risk and Uncertainty

This press release contains forward-looking statements based upon GTx's current expectations. Forward-looking statements involve risks and uncertainties. GTx's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks that (i) GTx and its collaboration partners will not be able to commercialize their product candidates if clinical trials do not demonstrate safety and efficacy in humans; (ii) GTx may not be able to obtain required regulatory approvals to commercialize product candidates; (iii) clinical trials being conducted by GTx and its collaboration partners may not be completed on schedule, or at all, or may otherwise be suspended or terminated; and (iv) GTx could utilize its available cash resources sooner than it currently expects and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product development programs or commercialization efforts. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTx's quarterly report on Form 10-Q filed November 6, 2008 contains under the heading, "Risk Factors," a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Cardo Medical (OTCBB: CDOM), a company engaged in the development of orthopedic medical devices, announces the femur-first versatility in surgical technique with its Uni-Compartmental Knee System. Uni-compartmental knee arthroplasty procedures are most commonly performed using tibial-first referencing surgical techniques; however the Cardo Medical Uni-Compartmental Knee system also provides surgeons with additional intra-operative versatility to easily adapt to femur-first surgical techniques. Dr. Andrew Yun, an orthopedic surgeon at St. John's Hospital in Santa Monica, CA, has performed numerous femur-first uni-compartmental arthroplasty procedures and commented, "I have been very satisfied with the ease of use and outcomes with this system. The Cardo engineering team has been incredible to work with, and I have enjoyed the responsiveness and quality of work which comes from this group." In addition, Dr. Jonathan Braslow, an orthopedic surgeon at JFK Memorial Hospital in Indio, CA, also stated, "The Cardo Align 360 instrumentation system eliminates the guesswork for the first cut, the system was easy and simple to use and creates a reproducible outcome each time." The Align 360 Uni-Compartmental Knee System, Cardo Medical's initial product release, has been used successfully since its introduction in January 2007. System enhancements for the femur-first approach include novel, unique femoral tibial alignment ("knee jack") instruments with dedicated alignment and resection guides.

Dr. Andrew Brooks, Chairman and Chief Executive Officer of Cardo Medical, stated, "The Cardo Medical Uni-Compartmental Knee system was our first commercially available arthroplasty system, and also set the standards of simplicity, versatility and reproducibility we design into all our system offerings. The Align 360 Uni-Compartmental Knee system enables surgeons the flexibility to choose between both a tibial-first or femoral-first referencing and resection surgical technique and approach. With its innovative alignment and conservative resection instrumentation, the system easily adapts to any surgeons' training and methodology, including use with mechanical or computer assisted surgical navigation. We are pleased to offer intra-operative versatility within all of our systems and continue to offer modularity and interchangeability, especially within our Align 360 knee platform. Our innovations especially with regards to instrumentation, surgical approaches and techniques enable surgeons to achieve excellent surgical outcomes."

AIDS was the top fatal infection among the Chinese in 2008, followed by TB, rabies, hepatitis, and infant's tetanus, said a government report released earlier this week by China's Ministry of Health.

China's state-run news agency, Xinhua reported that the official figures show that AIDS claimed 6,897 lives in China between January and September 2008, putting it at the top of the list of infectious diseases for that country for the first time, jumping from the third position it occupied three years ago.

There were 264,302 confirmed cases of people with HIV in September last year, said the Ministry of Health, 34,864 of whom have since died; five times the equivalent number of three years ago. The accumulated cases is nearly double the figure for 2005, which showed 135,630 Chinese had been infected by the virus.

Although the Chinese government did not elaborate on the reasons behind the jump in HIV/AIDS cases and deaths, a recent report in the Associated Press (AP) suggests that the Chinese government's willingness to gradually acknowledge the presence of the disease could be a factor.

There has been no reaction to the figures from UNAIDS or the World Health Organization in Geneva, said the AP report, which mentions that UNAIDS estimates there are 700,000 people living with HIV in China, of whom around 85,000 have AIDS.

According to the Chinese authorities, AIDS came to China in 1982 and their first death from the disease was three years later.

Since 2003 there has been a government policy of "four frees, one care" for all HIV carriers and AIDS patients in China. "Four frees" are free testing for HIV, free counselling and treatment fro HIV infected people in rural areas, free drugs for all pregnant women with HIV, and free education for children orphaned by AIDS.

The "one care" is help for those impoverished by AIDS and the "elimination of AIDS-related discrimination", said the Xinhua report.

According to the AP report, HIV spread in China was caused by tainted blood transfusions and unsanitary blood plasma, but a government report last year said that sex and drugs had now overtaken other causes of HIV spread in the country.

Earlier this week, AHN reported that the World Health Organization is predicting a rise in HIV/AIDS infection rates in Asia among men who have sex with men and this group urgently needs better access to healthcare if the rise is to be avoided.

WHO's adviser on HIV/AIDS in the Western Pacific, Mssimo Ghidinelli told the press that the spread of HIV through men who have sex with men was much bigger than they first thought.

WHO suggests there are some 10 million men who have sex with men in Asia, the highest number of any region in the world.

At the WHO Technical Consultation on Health Sector Response to HIV/AIDS held in Hong Kong on Wednesday, York Chow, Hong Kong's secretary for food and health, said that HIV prevention among men who have sex with men has been the main focus of the city's five-year HIV/AIDS programme which runs from 2006 to 2011.

Chow said HIV rates among men who have sex with men have risen sharply in recent years, accounting for 30 per cent of the 300 to 400 new cases reported every year, reported Xinhua. Chow said most men who have sex with men don't know their HIV status and unprotected sex is a major factor in the spread of the virus.

Government officials from throughout Asia plus representatives from Australia and New Zealand attended the conference.

WASHINGTON: Scientists have identified two genetic mutations they believe are linked with the most common types of brain cancer and longer survival
times. Researchers at Johns Hopkins and Duke universities discovered variations in the IDH1 and IDH2 genes that are associated with three quarters of the most common types of cancer tumors, known as gliomas.

It is hoped the findings could open the way to more successful treatment of the disease. Patients with these types of mutations can survive at least two times longer than those with other genetic variations, according to the work, which was published in the February 19 addition of the New England Journal of Medicine.

"Pathologists may find it useful to determine IDH1/IDH2 status to help identify and classify these cancers," said Williams Parsons, a visiting professor in pediatric oncology at Johns Hopkins. "The IDH mutation could serve as a biomarker that would help single out individuals who are likely to have better outcomes and receive different treatment," said Darell Bigner of Duke University and a coauthor of the report.

Source:- Times Of India

STOCKHOLM: Drunken driving is not just an indication of a deeply seated alcohol problem but is also very often connected to psychological disease
and chronic criminal background, says a doctoral thesis presented at the Karolinska Institute (KI). Psychologist Beata Hubicka has in collaboration with the Swedish traffic authority, Vagverket, and the police, carried out a nationwide study involving 1,200 drivers who were charged with drunken driving.

The suspect alcoholic offenders, along with a research group of 786 assuredly sober drivers, were called upon to answer a questionnaire on their alcohol consumption habits. The psychosocial and psychotic health condition of some of the drunken drivers was examined too.

"Earlier research in this area has mostly been undertaken in the US," Hubicka told IANS, after her dissertation at the KI. "However, it became essential to carry out an entirely Swedish study since we have different promille (alcohol in the blood permissible for driving) limits and different attitudes towards drunken driving compared to the US. Such variables have also to be taken into account when dealing with this problem in other countries."

The well-received study shows that "more than a half of the suspected alcohol abusers had earlier committed criminal offences. A large number among the abusers were also found to be suffering serious psychotic problems." "Since such a large number have psychotic problems and a criminal background," says Hubicka, "one should not direct attention solely towards their alcohol problem in any preemptive efforts to resolve drunken driving".

Hubicka said: "The current limit for drunken driving of 0.2 promille (in Sweden, among the strictest globally) is based on physiological studies in which it has been observed and recorded that our capacity for reaction (reflexes) is dangerously impaired with such an alcohol level (in the blood). Since alcohol abuse is such a big risk factor (cause) for drunken criminality, the result of our study should perhaps form the basis for a reconsidered alcohol limit for driving. I would rather suggest that we follow the few countries that have established zero-tolerance."

Source: Times of India