�Millennium: The Takeda
Oncology Company proclaimed the publication of results from the 682
patient role, randomized, Phase III VISTA(1) trial in this week's edition of the
New England Journal of Medicine. The results showed a significant natural selection
benefit and a 30 percent nail remission (CR) rate with VELCADE,
alkeran and meticorten (VcMP) compared to 4 percent for melaphalan and
prednisone (MP) alone in previously untreated multiple myeloma patients.
Multiple myeloma is the second most common blood cancer.
"These data demonstrate that treatment with VELCADE asset melphalan and
prednisone leads to a survival benefit and a high nail remission in
previously untreated patients with multiple myeloma," said Professor Jesus
San Miguel, M.D., Ph.D., Hematology Department Head, University Hospital of
Salamanca and Principal Investigator of the test. "The combination of
VELCADE plus alkeran and meticorten is an important fresh option for these
patients."
These data originally were presented at the 2007 American Society of
Hematology (ASH) Annual Meeting. Based on these positive tribulation results, the
U.S. Food and Drug Administration approved VELCADE for patients with
previously untreated multiple myeloma on June 20, 2008. The Phase III VISTA
trial was conducted by Millennium and its co-development partner Johnson &
Johnson Pharmaceutical Research & Development, L.L.C. in 151 centers
worldwide.
"We are proud to have these information published in such a highly honored
journal," said Nancy Simonian, M.D., Chief Medical Officer, Millennium.
"We're delighted that previously untreated multiple myeloma patients now
can benefit from this VELCADE based therapy as have patients in the
relapsed and refractory settings since 2003."
(1) VELCADE as Initial Standard Therapy in multiple myeloma: Assessment
with alkeran and prednisone
VISTA Trial Results
Patient responses were evaluated by the stringent European Group for
Blood and Marrow Transplantation (EBMT) criteria:
-- A CR rate of 30 percent in the VcMP arm compared to 4 percent with
MP (p
-- VcMP demonstrated statistical significance in overall survival with
a 39 percent reduction in danger of death (Hazard ratio= 0.61; p=0.008) with
a follow-up of 16.3 months
-- The median treatment continuance was 46 weeks for the VcMP arm compared
to 39 weeks for the control arm and discontinuation ascribable to inauspicious events
was similar in both arms
Patients in the VcMP arm received VELCADE at 1.3 mg/m2 twice weekly in
weeks one, two, four and basketball team for foursome six-week cycles (eight doses per
bike), followed by once weekly on weeks one, 2, four and five for up to
five six-week cycles (four doses per cycle) in combination with melphalan
at 9 mg/m2 and liquid Pred at 60 mg/m2 at one time daily on days 1 through 4 of
each cycle for up to nine six-week cycles. For both groups, treatment
continued for a maximum of 54 weeks.
"The tolerability of VcMP also was encouraging and side effects were
more often than not manageable with appropriate supportive care and dose reduction as
needed," commented Paul Richardson, M.D., Clinical Director of the Jerome
Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute and Senior
Investigator on the study.
The safety profile of VELCADE in combination with MP is consistent with
the known safety profiles of both VELCADE and MP. In VISTA, the most
usually reported untoward events for VELCADE in combination with MP vs MP,
respectively, were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%),
sickness (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46% vs
17%), anemia (43% vs 55%), constipation (37% vs 16%), neuralgia (36% vs
1%), leukopenia (33% vs 30%), vomiting (33% vs 16%), pyrexia (29% vs 19%),
fatigue (29% vs 26%), lymphopenia (24% vs 17%), anorexia (23% vs 10%),
asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema
peripheral (20% vs 10%), skin rash (19% vs 7%), endorse pain (17% vs 18%),
pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% vs 13%),
headache (14% vs 10%), pain in extremity (14% vs 9%), abdominal painfulness (14%
vs 7%), paraesthesia (13% vs 4%), herpes zoster (13% vs 4%), bronchitis (13%
vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain
upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%),
nasopharyngitis (11% vs 8%), bone pain in the neck (11% vs 10%), arthralgia (11% vs
15%) and pruritus (10% vs 5%).
Important Safety Information
In the U.S., VELCADE is indicated for the treatment of patients with
multiple myeloma. VELCADE besides is indicated for the treatment of patients
with mantle cell lymphoma world Health Organization have received at least one prior therapy.
VELCADE is contraindicated in patients with hypersensitivity to bortezomib,
boron or mannitol. VELCADE should be administered under the supervising of
a physician experienced in the use of antineoplastic therapy.
Risks associated with VELCADE therapy include new or worsening
peripheral neuropathy, hypotension throughout therapy, cardiac and
pulmonary disorders, reversible buns leukoencephalopathy syndrome,
gastrointestinal adverse events, thrombopenia, neutropenia, tumour lysis
syndrome and liverwort events. Women of childbirth potential should avoid
becoming pregnant spell being toughened with VELCADE. Nursing mothers are
advised not to breastfeed while receiving VELCADE. Cases of severe sensory
and motor peripheral neuropathy have been reported. The long-term event
of peripheral neuropathy has not been studied in mantle cell lymphoma.
Acute development or exacerbation of congestive warmheartedness failure, and new
onset of decreased left ventricular ejection fraction has been reported,
including reports in patients with no risk factors for decreased leftfield
ventricular expulsion fraction. There have been reports of acute permeate
infiltrative pulmonary disease of unknown aetiology such as pneumonitis,
interstitial pneumonia, lung infiltration and Acute Respiratory Distress
Syndrome in patients receiving VELCADE. Some of these events have been
fatal. There have been reports of Reversible Posterior Leukoencephalopathy
Syndrome (RPLS) in patients receiving VELCADE. RPLS is a rare, reversible,
neurological disorder which can buoy present with seizure, high blood pressure,
headache, inanition, confusion, cecity, and other visual and neurological
disturbances. VELCADE is associated with thrombocytopenia and neutropenia.
There have been reports of gastrointestinal and intracerebral bleeding in
association with VELCADE. Transfusions may be considered. Complete pedigree
counts (CBC) should be frequently monitored during discourse with VELCADE.
Cases of acute liver failure have been reported in patients receiving
multiple concomitant medications and with serious underlying medical
weather. Patients world Health Organization are concomitantly receiving VELCADE and drugs that
ar inhibitors or inducers of cytochrome P450 3A4 should be closely
monitored for either toxicities or decreased efficacy. Patients on oral
antidiabetic medication while receiving VELCADE should check blood sugar
levels frequently.
Adverse Reaction Data
Safety data from Phase II and III studies of single-agent VELCADE 1.3
mg/m2/dose twice weekly for 2 weeks followed by a 10-day rest period in
1163 patients with previously treated multiple myeloma (N=1008, non
including the Phase III, VELCADE asset DOXIL(R) [doxorubicin HCl liposome
injection] study) and antecedently treated pallium cell lymphoma (N=155) were
integrated and tabulated. In these studies, the condom profile of VELCADE
was similar in patients with multiple myeloma and blanket cell lymphoma.
In the integrated depth psychology, the most commonly reported adverse events
were asthenic conditions (including fatigue, unease and weakness) (64%),
sickness (55%), looseness (52%), irregularity (41%), peripheral neuropathy NEC
(including peripheral sensory neuropathy and peripheral neuropathy
aggravated) (39%), thrombocytopenia and appetite decreased (including
anorexia) (each 36%), fever (34%), vomiting (33%), anemia (29%), hydrops
(23%), head ache, paresthesia and dysesthesia and headache (each 22%),
dyspnea (21%), coughing and insomnia (each 20%), rash (18%), arthralgia (17%),
neutropenia and dizziness (excluding vertigo) (each 17%), hurting in limb and
abdominal muscle pain (each 15%), os pain (14%), back pain in the neck and hypotension (each
13%), herpes zoster, nasopharyngitis, pep pill respiratory tract infection,
myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and
anxiety (each 10%). Twenty percent (20%) of patients experienced at least 1
episode of greater than or equalize to Grade 4 toxicity, most unremarkably
thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients
experient serious untoward events (SAEs) during the studies. The most
ordinarily reported SAEs included pneumonia (7%), febrility (6%), looseness of the bowels
(5%), puking (4%), and nausea, dehydration, dyspnea and thrombocytopenia
(each 3%).
About Multiple Myeloma
Multiple myeloma is the endorsement most mutual hematological malignance.
Between 2001 - 2005, the medial age of diagnosis was 70 long time. In 2007,
there were 110,000 patients living with multiple myeloma across the United
States, Europe and Japan. It is estimated that this number will growth by
5.6 % annually over the next few years due to new therapies extending the
lives of multiple myeloma patients.
About VELCADE
VELCADE is being co-developed by Millennium: The Takeda Oncology
Company and Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Millennium is responsible for commercialization of VELCADE in the U.S. and
Janssen-Cilag is responsible for commercialization in Europe and the perch
of the world. Janssen Pharmaceutical K.K. is responsible for
commercialisation in Japan.
About Millennium
Millennium: The Takeda Oncology Company, and a leading
biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a
novel cancer product, and has a robust clinical development pipeline of
product candidates. Millennium research, development and commercialisation
activities ar focused in oncology. Additional information about Millennium
is available through its site, http://www.millennium.com.
Millennium
http://www.millennium.com
View drug information on Doxil; Velcade.
More info
Saturday 6 September 2008
Wednesday 27 August 2008
Stefani and Rossdale have baby boy
Gwen Stefani and her husband Gavin Rossdale are celebrating the birth of their minute child together.
Their son, Zuma, was born weighing 8.5lbs.
In a statement, the couple's spokesperson aforementioned mother and baby were "happy and healthy".
Thirty-eight-year-old Stefani and 40-year-old Rossdale have another son, Kingston, wHO was born in 2006.
More info
Sunday 17 August 2008
Download Grandmaster Flash mp3
 Artist: Grandmaster Flash: mp3 download Genre(s): Electronic Discography:  The Official Adventures Of Year: 2002 Tracks: 13  Ministry of Sound Session Year: 2002 Tracks: 1  Live in NYC Year: 1995 Tracks: 1  Ba-Dop-Boom-Bang ... and Even More Year: 1987 Tracks: 18  The Geatest Hits of Grandmaster Flash Year: 1984 Tracks: 14  More Hits From... Year: 1984 Tracks: 11  Message Year: 1982 Tracks: 8  Grandmaster Flash V The Sugarhill Gang Year: Tracks: 17 DJ Grandmaster Flash and his group the Furious Five were hip-hop's sterling innovators, transcending the genre's party-music origins to explore the total background of its lyrical and sonic horizons. Flash was natural Joseph Saddler in Barbados on January 1, 1958; he began spinning records as teenager growing up in the Bronx, performing springy at arena dances and impede parties. By old years 19, spell attending skilful school courses in electronics during the day, he was as well spinning on the local discotheque circuit; over time, he developed a series of groundbreaking techniques including "cut" (moving betwixt tracks on the nose on the beat), "back-spinning" (manually turning records to recur brief snippets of sound), and "phasing" (manipulating turntable speeds) -- in short, creating the canonic vocabulary which DJs keep to come with regular today. Flash did non begin collaborating with rappers until around 1977, number one teaming with the fabled Kurtis Blow. He then began working with the Furious Five -- rappers Melle Mel (Melvin Glover), Cowboy (Keith Wiggins), Kid Creole (Nathaniel Glover), Mr. Ness aka Scorpio (Eddie Morris), and Rahiem (Guy wire Williams); the group cursorily became legendary throughout New York City, attracting notice not only for Flash's one and only skills as a DJ merely as well for the Five's masterly rapping, most famous for their signature trading and blending of lyrics. Despite their local popularity, they did non phonograph recording until after the Sugarhill Gang's crush "Rapper's Delight" proved the beingness of a market for rap music releases; after releasing "We Rap More Mellow" as the Younger Generation, Flash and the Five recorded "Superappin'" for the Enjoy label owned by R&B legend Bobby Robinson. They then switched to Sugar Hill, owned by Sylvia Robinson (no relative), after she promised them an chance to rap over a stream DJ front-runner, "Get Up and Dance" by Freedom (the musical theme had belike been originally conceived by Crash Crew for their unmarried "High Powered Rap"). That record, 1980's "Freedom," the group's Sugar Hill debut, reached the Top 20 on national R&B charts on its direction to merchandising over 50,000 copies; its followup, "Natal day Party," was besides a stumble. 1981's "The Adventures of Grandmaster Flash on the Wheels of Steel" was the group's beginning unfeignedly watershed recording, introducing Flash's "clipping" techniques to create a stunning sound collage from snippets of songs by Chic, Blondie, and Queen. Flash and the Five's future effort, 1982's "The Message," was even more revelatory -- for the first time, rap music became a vehicle not just for crowing and self-praise but for searching social comment, with Melle Mel delivering a blistering rap detailing the forbidding realities of life in the ghetto. The record was a major vital hit, and it was an tremendous step in hardening rap as an important and enduring mannikin of musical expression. Following 1983's anti-cocaine polemic "White River Lines," dealings between Flash and Melle Mel sour ugly, and the rapper presently left hand the group, forming a new unit too dubbed the Furious Five. After a series of Grandmaster Flash solo albums including 1985's They Said It Couldn't Be Done, 1986's The Source, and 1987's Da Bop Boom Bang, he reformed the original Furious Five lineup for a jacob's ladder concert at Madison Square Garden; before long subsequently, the reconstituted grouping recorded a new LP, 1988's On the Strength, which earned a lukewarm reception from fans and critics alike. Another reunification followed in 1994, when Flash and the Five joined a blame parcel tour also including Kurtis Blow and Run-D.M.C. A year subsequently, Flash and Melle Mel as well appeared on Duran Duran's cover of "White Lines." Except for a few compilations during the belated '90s, Flash was comparatively quiet until 2002, when a geminate of mix albums appeared: The Official Adventures of Grandmaster Flash on Strut and Essential Mix: Classic Edition on ffrr. |
Jerry Lewis says gun in baggage was telethon gift
Friday 8 August 2008
American Idol star promises "twists and turns"
'American Idol' winner David Cook has been talk about his debut album, which is due out later this year.
Billboard reports that Cook hopes to release the album in November.
Cook said: "I just want the record to be both eclectic and cohesive and have something to state. The music is sway and it's pretty undeniably me, which I'm pretty excited about."
He likewise said there would be "some interesting twists and turns... that will keep people interested".
More info
Tuesday 1 July 2008
Wednesday 18 June 2008
Seether lines up a busy summer
South African rock band Seether [ tickets ] has lined up a tour of secondary markets, and is bringing along the likes of Sick Puppies [ tickets ] and Finger Eleven [ tickets ] on multiple dates. The tour kicks off on Independence Day at Milwaukee's Summerfest and continues through an Aug. 24 finale in Nampa, ID. Seether is currently enjoying one of its biggest hits to date, "Fake It," which is the lead track off of last October's "Finding Beauty in Negative Places." The second single, "Rise About This," is gaining momentum on the Billboard Hot 100 singles chart, where it sits at No. 92. The album, which follows 2005's gold-certified "Karma and Effect," reached No. 9 on The Billboard 200. The band also released a live, acoustic set, "One Cold Night," in 2006. Sick Puppies are touring in support of the single "What Are You Looking For," taken from the album "Dressed Up As Live," the Australian band's North American debut album.Recently, Sick Puppies--Shimon Moore (guitar and vocals), Emma Anzai (bass), Mark Goodwin (drums)--completed a two-month headline tour, as well as a series of gigs supporting Evanescence, Deftones, Velvet Revolver, Chris Cornell, Flyleaf, Chevelle, Breaking Benjamin, 3 Doors Down and Finger Eleven. Finger Eleven, who scored a hit with the song "Paralyzer," has canceled all June European dates after singer Scott Anderson injured his neck. In a message to fans on Finger Eleven's webpage, he wrote: "You see: I broke something in and around my neck area. Well, the doc says I sprained it. You know how they always say a sprain is worse than a break? Well, I think I'll stick with a sprained neck over a broken one! Am I right, Internet?" The US dates are a go. Finger Eleven is pushing its album "Them vs. You vs. Me."
Monday 9 June 2008
R. Kelly trial: Sun-Times critic ordered to come to court
There will be no jail time for Jim DeRogatis, but the R. Kelly trial judge ordered the Sun-Times music critic to come to court Wednesday.
A subpoena had been issued compelling him to appear Tuesday, but DeRogatis never showed.
The newspaper argued the renowned music critic never received the subpoena, though a Sun-Times reporter, attorney and the editor-in-chief's assistant all received legal documents indicating he was expected in court, according to statements made before Cook County Judge Vincent Gaughan.
Gaughan said it was possible DeRogatis was unaware of the ordered appearance and would not issue a warrant for his arrest.
"I'm going to give him the benefit of the doubt," Gaughan said.
Gaughan ordered DeRogatis to appear Wednesday so the defense can question him in front of the jury about his connection to the sex tape at the heart of the case. DeRogatis, who first wrote about Kelly's relationships with young girls in 2000, received the video from an unknown sender in early 2002.
The critic turned the tape over to the Chicago police, prompting an investigation that eventually led to child pornography charges against the singer.
The Sun-Times contends DeRogatis is protected by the reporter's privilege and is not required to testify about information he gathered as a journalist. The judge, however, has ruled he is connected to the trial's most critical piece of evidence and can be questioned.
"He's a material witness," Gaughan said. "He turned over [the sex tape], which is the basis of this prosecution."
The Sun-Times intends to appeal the judge's decision and ask the appellate court to bar DeRogatis from being called as a witness until the matter is settled. Gaughan said he will not delay the testimony unless a higher court orders him to do so.
"I have 15 people in the jury box and this trial is into its fourth week," Gaughan said.
Stacy St. Clair
June 3, 2008 2:04 PM: Newspaper's attorney files appeal on critic's behalf--with the wrong court
Arguments continue over whether Sun-Times music critic Jim DeRogatis will have to appear today before the trial judge in the R. Kelly child pornography case.
Sun-Times lawyer Damon Dunn reasserted that it would be a "serious breach" of DeRogatis' rights if he were compelled to testify as a reporter and said he had appealed last week's decision by the judge ordering the critic to testify.
Kelly's defense team wants DeRogatis to testify about the sex tape at the center of the prosecution's case. Specifically, defense attorneys are interested in what DeRogatis may have done with the tape between the time he received it in early 2002 and when he gave it to police.
Dunn asserted that the Illinois reporter's privilege statute protects the critic from having to testify while an appeal is pending. The judge pointed out, however, that Dunn's notice of appeal was filed to the wrong court—at the Daley Center—and as such is not really on file at this point.
"You filed it in the wrong court," Gaughan snapped. "A notice of appeal has to be filed at the appellate court." Gaughan also rehashed his finding that DeRogatis is not protected under the law as a reporter because he is a "a material witness to a crime" and is not protecting a source.
In his opinion issued Monday, Gaughan said the defense could not ask about the source of the tape and that Kelly attorney Marc Martin said the defense had no plans to ask about the source.
"You're protecting something that nobody is after," Gaughan said to Dunn.
A subpoena had been issued compelling him to appear Tuesday, but DeRogatis never showed.
The newspaper argued the renowned music critic never received the subpoena, though a Sun-Times reporter, attorney and the editor-in-chief's assistant all received legal documents indicating he was expected in court, according to statements made before Cook County Judge Vincent Gaughan.
Gaughan said it was possible DeRogatis was unaware of the ordered appearance and would not issue a warrant for his arrest.
"I'm going to give him the benefit of the doubt," Gaughan said.
Gaughan ordered DeRogatis to appear Wednesday so the defense can question him in front of the jury about his connection to the sex tape at the heart of the case. DeRogatis, who first wrote about Kelly's relationships with young girls in 2000, received the video from an unknown sender in early 2002.
The critic turned the tape over to the Chicago police, prompting an investigation that eventually led to child pornography charges against the singer.
The Sun-Times contends DeRogatis is protected by the reporter's privilege and is not required to testify about information he gathered as a journalist. The judge, however, has ruled he is connected to the trial's most critical piece of evidence and can be questioned.
"He's a material witness," Gaughan said. "He turned over [the sex tape], which is the basis of this prosecution."
The Sun-Times intends to appeal the judge's decision and ask the appellate court to bar DeRogatis from being called as a witness until the matter is settled. Gaughan said he will not delay the testimony unless a higher court orders him to do so.
"I have 15 people in the jury box and this trial is into its fourth week," Gaughan said.
Stacy St. Clair
June 3, 2008 2:04 PM: Newspaper's attorney files appeal on critic's behalf--with the wrong court
Arguments continue over whether Sun-Times music critic Jim DeRogatis will have to appear today before the trial judge in the R. Kelly child pornography case.
Sun-Times lawyer Damon Dunn reasserted that it would be a "serious breach" of DeRogatis' rights if he were compelled to testify as a reporter and said he had appealed last week's decision by the judge ordering the critic to testify.
Kelly's defense team wants DeRogatis to testify about the sex tape at the center of the prosecution's case. Specifically, defense attorneys are interested in what DeRogatis may have done with the tape between the time he received it in early 2002 and when he gave it to police.
Dunn asserted that the Illinois reporter's privilege statute protects the critic from having to testify while an appeal is pending. The judge pointed out, however, that Dunn's notice of appeal was filed to the wrong court—at the Daley Center—and as such is not really on file at this point.
"You filed it in the wrong court," Gaughan snapped. "A notice of appeal has to be filed at the appellate court." Gaughan also rehashed his finding that DeRogatis is not protected under the law as a reporter because he is a "a material witness to a crime" and is not protecting a source.
In his opinion issued Monday, Gaughan said the defense could not ask about the source of the tape and that Kelly attorney Marc Martin said the defense had no plans to ask about the source.
"You're protecting something that nobody is after," Gaughan said to Dunn.
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