Telik anuncia el inicio de un ensayo clínico fase 2 de Telintra ® (clorhidrato de Ezatiostat) en pacientes con Revlimid o resistentes eliminación 5q refractarios ® síndrome mielodisplásico

Fuente

PALO ALTO, California, 7 de junio 2011 / PRNewswire / - Telik, Inc. (NASDAQ: Telk) ha anunciado hoy el inicio de una fase 2 del ensayo clínico para evaluar Telintra oral en pacientes con Revlimid refractaria o resistente, eliminación 5q síndrome mielodisplásico ( deleción del cromosoma 5q MDS).

Se trata de un ensayo multicéntrico pretende inscribir hasta a 117 pacientes evaluables. Se emplea un diseño secuencial con dos análisis intermedios. Estos pacientes son dependientes de transfusión con baja a intermedia MDS-1 de riesgo. Telintra será administrado durante 21 días, seguido de un período de descanso de una semana en ciclos de cuatro semanas. El objetivo principal es determinar la tasa de respuesta hematológica mejora-eritroides (HI-E), medida por la reducción de la transfusión o la independencia, de acuerdo con el Grupo de Trabajo Internacional MDS 2006 criterios. Los objetivos secundarios incluyen la determinación de la mejora hematológica de neutrófilos (HI-N) y hematológicas mejora de plaquetas (HI-P) las tasas de respuesta y seguridad.

Este ensayo sigue la fase de completado recientemente dos estudios en los no-del 5q MDS informó en la 52 ª Reunión Anual de la Sociedad Americana de Hematología 2010 en Orlando, FL, "Fase 2 Estudio aleatorizado multicéntrico de extendido de dosificación oral Ezatiostat Listas de HCl (Telintra) , un análogo de glutatión, glutatión-S-transferasa P1-1 (GSTP1-1) inhibidor, en bajo a intermedio-1 de riesgo del síndrome mielodisplásico (SMD) ", Ramos, A., Galili, N. Smith, S., et al. (Abstract # 2910) donde se observó evidencia de actividad clínica en esta población de pacientes. Los pacientes con deleción del cromosoma 5q MDS tienen opciones limitadas de tratamiento después de convertirse en resistentes a tratamiento con Revlimid y representan una importante necesidad médica no cubierta.

Antecedentes de MDS y Telintra

El síndrome mielodisplásico es un grupo heterogéneo de trastornos clonales de células madre hematopoyéticas se caracteriza por la hematopoyesis ineficaz (producción de células sanguíneas), relacionados con uno o varios linajes de células (glóbulos rojos, glóbulos blancos o plaquetas) y un riesgo variable de transformación a leucemia mieloide aguda. Se estima que afecta a MDS a unas 300.000 personas en todo el mundo. Según la Sociedad Americana del Cáncer, 10.000-20.000 nuevos casos de SMD son diagnosticados cada año en los Estados Unidos, con tasas de supervivencia que van desde seis meses a seis años. pacientes con MDS a menudo requieren múltiples transfusiones de sangre para controlar su enfermedad.

Sigue siendo una necesidad crítica de terapias efectivas y bien tolerado para el SMD. Telintra tiene un novedoso mecanismo de acción que inhibe una enzima llamada glutatión S-transferasa P1-1, que conduce a la activación de Jun quinasa, un regulador clave del crecimiento celular y la diferenciación de células precursoras de sangre. Telintra se ha demostrado para estimular diferenciarse en diferentes líneas de sangre normal de precursores de células madre y cáncer de inducir la muerte celular, o apoptosis, en líneas celulares de leucemia humana. Telintra también está siendo evaluada en un estudio clínico de fase 1 en combinación con lenalidomida (Revlimid ®) en pacientes con SMD, y en una fase exploratoria dos estudios aleatorios en pacientes con neutropenia severa crónica idiopática. Información adicional acerca de Telintra está disponible en www.telik.com .

Acerca de Telik, Inc.

Telik, Inc., de Palo Alto, CA, es una droga estadio clínico empresa de desarrollo centrada en el descubrimiento y desarrollo de fármacos de moléculas pequeñas para tratar el cáncer. La compañía fármaco candidato más avanzado es Telintra ®, un análogo de glutatión modificados destinados para el tratamiento de trastornos hematológicos, incluyendo síndrome mielodisplásico, seguido por Telcyta ®, un cáncer activado profármaco para el tratamiento de una variedad de cánceres. candidatos Telik de productos fueron descubiertos utilizando su tecnología patentada de descubrimiento de fármacos, TRAMPA ®, que permite el descubrimiento rápido y eficiente de los pequeños candidatos molécula de la droga.

Este comunicado de prensa contiene "declaraciones prospectivas" sobre el futuro desarrollo de Telintra, la seguridad y la eficacia de Telintra en el tratamiento de MDS, si los resultados Telintra tratamiento en la mejora hematológica en pacientes con SMD y ofrece una alternativa a las transfusiones de sangre de glóbulos rojos, el uso de Telintra en pacientes refractarios o resistentes al tratamiento con Revlimid, el uso de Telintra en el tratamiento de SCIN, y el uso de Telcyta para el tratamiento del cáncer. Estas declaraciones prospectivas se basan en las expectativas actuales Telik y hay factores importantes que podrían causar que los resultados reales difieran materialmente de los indicados en estas declaraciones prospectivas. información detallada sobre los factores que pueden causar que los resultados reales difieran materialmente de los resultados expresados ​​o implícitos en las declaraciones de este comunicado de prensa se puede encontrar en las presentaciones periódicas Telik ante la Comisión de Bolsa y Valores, incluyendo los factores descritos en la sección titulada "Factores de Riesgo" en su informe anual en Forma 10-K para el año que terminó el 31 de diciembre 2010. Telik no asume ninguna obligación de actualizar las declaraciones prospectivas contenidas en este comunicado de prensa.

TELIK, el logotipo de Telik, TELINTRA, TELCYTA y TRAP son marcas comerciales o marcas comerciales registradas de Telik, Inc.
 

Primer trasplante de riñón sin sangre realizado con éxito en Moolchand La India

http://www.expresshealthcaremgmt.com/201106/market06.shtml

La cirugía sin sangre elimina los efectos adversos, disminuye las tasas de infección y minimiza la inmunosupresión, lo que resulta en menor estancia hospitalaria y un trato más rentable, sin necesidad de equipo especial

Una primera cirugía de trasplante de riñón sin sangre se llevó a cabo con éxito en Moolchand Hospital, Nueva Delhi, el 3 de mayo de 2011. Con esto, Moolchand ha establecido un nuevo punto de referencia en el trasplante de órganos. Un equipo dirigido por el Dr. Ramesh Kumar, consultor senior y asesor en nefrología y trasplante, el Dr. SA Bhatyal, cirujano de trasplantes superiores y el Dr. Vijay Langer, consultor senior de anestesiología logrado esta hazaña con la improvisación y la innovación en la asistencia sanitaria sin transfusión de sangre.

Los médicos fueron abordados por los miembros de los Testigos de Jehová, una secta cristiana que buscan atención médica de calidad y aceptar la mayoría de los tratamientos médicos, pero por razones religiosas, no aceptan transfusiones de sangre y por lo tanto, pidió alternativas no sanguineas. Con el recuento de hemoglobina del paciente tan bajo como 30 por ciento de los niveles normales, es decir., 4,2 Hb, cualquier procedimiento quirúrgico era casi imposible para la anestesia. Cualquier procedimiento quirúrgico importante, como el trasplante de órganos que plantean un peligro mayor. En este caso, la vida de ambos el receptor y el donante se encontraban en riesgo, cualquier fallo afectaría a los dos. El Dr. Ramesh Kumar, Consultor Senior y Asesor en Nefrología y Trasplante Renal Care Moolchand y Diálisis, dijo, "Nosotros respetamos los valores religiosos con la ética y proporcionar atención médica de alto nivel. Después del trasplante, el donante y el receptor están bien y estables y ahora puede llevar una vida normal y será dado de alta en dos o tres días. Esta cirugía sin sangre proporciona menor tiempo de hospitalización, el tratamiento coste-efectivo, no requiere equipos especiales, eliminar los efectos adversos, menores tasas de infección y reducir la inmunosupresión, etc y puede ser un milagro para los pacientes que buscan trasplante de riñón. "
 

What if some other behavior cost 25 million lives?

Campaign chief says actions linked to terminal AIDS largely ignored

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Posted: June 09, 2011
10:15 pm Eastern By Bob Unruh © 2011 WND


The chief of a watchdog organization working to combat the spread of HIV and AIDS has launched a campaign to demand a government investigation of – and action over – the homosexual behavior that has been linked to more than 25 million deaths over the last 30 years, likening the problem to smoking, which was blamed for 100 million deaths in the 20th century.

Although statistics on the diseases linked to homosexual activity notoriously are hard to obtain, a report from the International Journal of Epidemiology estimated from a review of the "gay" population of Vancouver, B.C., that HIV/AIDS costs homosexuals up to 20 years of their lives on average.

And the U.S. government is spending, according to a Congressional Research Services report to Congress, in the range of $20 billion a year for treatment and research, with a small fraction for prevention that, analysts explain, includes testing but largely doesn't address the behavior itself.

That's even though when another threat to lives and livelihood – cigarettes – were suspected of imposing such a cost, Washington mandated exhaustive studies, imposed draconian advertising limits, demanded warning labels and imposed outright bans in many circumstances. It said the behavior, smoking, could be changed.

"It's a public health question," Peter LaBarbera, president of Americans for Truth about Homosexuality, told WND. "We've got to get beyond the gay politics and get back to the behaviors. We know there are high risks."

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He recent publicly demanded a federal government review of the problem and action regarding it. He issued the call to action at a recent Reclaim Oklahoma conference and he later explained the idea to WND.

"We need to pull this information together," he said. "We would, if it were from any other behavior, where one in five men who practice come down with this awful disease called AIDS."

On his website, LaBarbera explained that homosexual behavior is like the behavior of smoking, which the U.S. government investigated and addressed directly by requiring warnings and other limits.

"Men who have had sex with men since 1977 have an HIV prevalence 60 times higher than the general population and 800 times higher than first-time blood donors," LaBarbera wrote, citing a federal report that touched on the issue.

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"When it comes to combating cigarettes, the government not only restricts, taxes and bans smoking, it also funds and encourages anti-smoking messages and advertisements," LaBarbera said. "Given the immense health risks of male homosexual sex, shouldn't the federal government do a comprehensive study on the matter, tax sodomitic establishments like bathhouses, and educate the public and especially young people about the dangers of 'gay' sex?"

That smoking costs dearly isn't disputed. According to Health.com, researchers at the University of Bristol in England determined that for each cigarette, a smoker loses approximately 11 minutes of lifetime.

"That means that 10 cigarettes a day for 10 years takes more than nine months off your life."

The report also reveals tobacco "was responsible for the deaths of 100 million people in the 20th century."

Additionally, a Washington Post report said on average, smokers lose about 10 years of lifetime. "The pioneering epidemiologist Richard Doll, who's now 91, and his colleagues found that almost half of all persistent cigarette smokers were killed by their habit, and a quarter died before age 70," the report said.

But it also found that "kicking the cigarette habit had equally dramatic effects … someone who stops smoking by age 30 has the same average life expectancy as a nonsmoker, and someone who stops at 50 will lose four, rather than 10, years of life."

There's evidence that homosexuality's link to HIV and AIDS also is costly.

"In the U.S., recent research has identified HIV/AIDS as the leading cause of death among men aged 25-44 in the states of New York, New Jersey, California, Florida and Massachusetts, and 64 out of 170 cities having reported at least 25 AIDS-related deaths," said the Journal of Epidemiology. "Similarly, in Europe and Canada HIV/AIDS is now the leading cause of death in middle-aged men in several urban centers. Deaths attributable to HIV have led to an enormous burden on adult and childhood mortality in developing areas of the globe, such as sub-Saharan Africa."

According to the American Family Association of Pennsylvania, men who have sex with men account for more than half of the many thousands of new HIV infections in the U.S. each year, and the rate for infection for that "MSM" population is "more than 44 times that of other men and more than 40 times that of women."

WSYR Television in New York said on this year's 30th anniversary of the identification of HIV and AIDs, more than 60 million people have been diagnosed with HIV and 25 million of those are dead, "as there is no cure."

USA Today described the origins:

"Few people took note when, on June 5, 1981, doctors reported that a strange and deadly new disease had turned up in five gay men in Los Angeles. Doctors, too, were perplexed by the illness, which turned its victims into prey for exotic microbes. All five suffered from Pneumocystis carinii, a fungus that feasts on the lungs; candida, another fungus that nests in the mouth and throat; and cytomegalovirus (CMV), a common cause of infection in transplanted organs.Normally, the immune system thwarts these microbes, which survive only in transplant patients, cancer patients and others whose defenses are down. But these men seemed to have as little resistance to hungry microbes as the stump of a fallen tree. In effect, they were decaying before their doctors' eyes."

Money already is being thrown at the problem, according to the research of the Fair Foundation.

Its research reveals that National Institutes of Health allocates $225,656 for research and related work for each HIV/AIDS death, but only $13,803 for diabetes research for each death from that. That was followed by $11,595 for prostate cancer research for each each from that.

Their results:

On the most recent World AIDS Day, Dr. Kevin Fenton of the National Center for HIV/AIDS said there are 56,000 new HIV infections each year in the U.S. with "stark disparities" in that "men who have sex with men … are most affected."

He also noted there is no "recovery" for AIDS victims as there is for smokers who quit.

"Because there is not yet a cure or vaccine, it is critical that we take action now and build upon the prevention milestones achieved this year," he said.

While there is much discussion about testing, identifying those infected and treatments with retrovirals and such, the discussion of preventing the behavior that contributes to the transmission is largely absent.

The discussion about smoking, however, gets directly to the point.

Tim McAfee, director of the CDC's Ofice on Smoking and Health, noted recently, "At the start of the decade, there were no states in the U.S. with comprehensive smoke-free laws in workplaces, restaurants, and bars, and less than one percent of Americans were protected… Today … 25 states and the District of Columbia – covering nearly 50 percent of Americans – prohibit smoking in workplaces, restaurants and bars."

Fenton said on the 2010 awareness day that Latinos have a high risk for HIV.

"Among Latinos, as is true with other U.S. populations, most individuals who become infected with HIV do so through male-to-male sexual contact. But heterosexuals are also at risk," Fenton said. "We must face head-on the factors that place Latinos at high risk, and we must redouble our HIV prevention efforts at the federal, state and local levels. Studies have shown a range of factors that may place Latinos at such high risk: lack of awareness about the risk of HIV infection; cultural and socioeconomic factors like poverty and language barriers; and concerns about immigrations status. Additionally, these factors may also prevent individuals from seeking HIV testing and treatment. Fear of stigma and discrimination may also represent barriers to HIV prevention and treatment, particularly among gay and bisexual men and people living with HIV."

The solution? New testing programs, he said.

"The sooner individuals learn they are infected, the sooner they can receive life-extending treatment. CDC recommends that everyone between the ages of 13 and 64 years be tested for HIV. Gay and bisexual men should be tested at least annually, and every three to six months if they are at increased risk for infection (e.g., have multiple or anonymous sex partners, or inject drugs)," he continued.

But not a word about quitting the dangerous behavior, even while the CDC confirms that those aged 30-34 who are diagnosed have only an 87 percent chance of surviving another three years. Those 45-49 who are diagnosed have only a 79 percent chance of surviving another three years.

LaBarbera noted that, "Not only do they [federal researchers] not condemn the behavior, they criticize those who oppose the behavior."

"So it's completely the opposite of the smoking thing. What they've done is recognize that smokers may be ostracized – they have to smoke outside the building. There's no concern for the feeling of the smokers. In the interest of making the air clean and making life healthier for everyone else, we have to not care about the smokers' feelings. If they have to be ostracized or made to feel bad, that's part of the public health," he said.

"On the contrary, regarding homosexuality, it's all about the feelings of the practicing homosexuals."

In fact, a report in the International Business Times cited a CDC report that appeared to "raise the possibility" that "homophobia is a factor in the racial disparity in HIV infection among gay and bisexual men in the U.S."

They were looking into why a "disproportionate" 45 percent of new HIV infections were accounted for by African-Americans.

"Negative attitudes toward homosexuality, either from their surrounding community or from within themselves, could make it difficult for men who have sex with men to acknowledge their risk for HIV and seek testing," the article quoted lead researcher Sara Nelson Glick, of the University of Washington in Seattle.

The article stated, "It is not yet known whether any efforts to address homophobia will ultimately curb HIV rates among gay and bisexual men."

LaBarbera noted that the government already has done some work on the comprehensive review he envisions, including a report from the Food and Drug Administration that explains why the government "defers" men who have had sex with other men as blood donors.

"This is because MSM are, as a group, at increased risk for HIV, hepatitis B and certain other infections that can be transmitted by transfusion," the report said.

"A history of male-to-male sex is associated with an increased risk for the presence of and transmission of certain infectious diseases, including HIV, the virus that causes AIDS. FDA's policy is intended to protect all people who receive blood transfusions from an increased risk of exposure to potentially infected blood and blood products," the federal report said.

Among the statistics the FDA cites:

• Men who have had sex with men since 1977 have an HIV prevalence (the total number of cases of a disease that are present in a population at a specific point in time) 60 times higher than the general population, 800 times higher than first time blood donors and 8,000 times higher than repeat blood donors.
  
  
  
• Men who have had sex with men account for the largest single group of blood donors who are found HIV positive by blood donor testing.
  
  
  
• Blood donor testing using current advanced technologies has greatly reduced the risk of HIV transmission but cannot yet detect all infected donors or prevent all transmission by transfusions. While today's highly sensitive tests fail to detect less than one in a million HIV infected donors, it is important to remember that in the U.S. there are over 20 million transfusions of blood, red cell concentrates, plasma or platelets every year.
  
  
  
• No alternate set of donor eligibility criteria (even including practice of safe sex or a low number of lifetime partners) has yet been found to reliably identify MSM who are not at increased risk for HIV or certain other transfusion transmissible infections.
  
  
  
• Men who have sex with men also have an increased risk of having other infections that can be transmitted to others by blood transfusion. For example, infection with the Hepatitis B virus is about five to six times more common, and Hepatitis C virus infections are about two times more common in men who have sex with other men than in the general population. Additionally, men who have sex with men have an increased incidence and prevalence of Human Herpes Virus-8 (HHV-8). HHV-8 causes a cancer called Kaposi's sarcoma in immunocompromised individuals.

"Male to male sex has been associated with an increased risk of HIV infection at least since 1977. Surveillance data from the Centers for Disease Control and Prevention indicate that men who have sex with men and would be likely to donate have a HIV prevalence that is at present over 15 fold higher than the general population, and over 2000 fold higher than current repeat blood donors (i.e., those who have been negatively screened and tested) in the USA. MSM continue to account for the largest number of people newly infected with HIV," the report said.

"We are saying the government needs to investigate the cause of this and do something," LaBarbera told WND. "It has happened with smoking. But in reality with homosexuality it's exactly the opposite. There's a lot of propaganda coming out of the CDC about homophobia. They won't shut down bathhouses. We know that hyperpromiscuous behavior is going on. They won't tell the truth that homosexual sodomy is directly related to all of these diseases."

"We need to raise the level of seriousness," LaBarbera said. "It's common sense to most people."

The government, however, is moving the opposite direction. In California, state lawmakers propose forcing schools to profile homosexuals and lesbians as role models for young children, a move that is not unique there.

Likewise, the White House is dedicated to a course of action that would "normalize" homosexuality within the ranks of the U.S. military – even to the point that chaplains would face pressure to endorse the homosexuality irrespective of their religious beliefs.