Medarex Announces Allowance of Investigational New Drug Applications for Wholly Owned Fully Human Anti-CD19 Antibody... ( Two Separate Clinical Studies Planne...)

HOME >> MEDICINE >> TECHNOLOGY

Medarex Announces Allowance of Investigational New Drug Applications for Wholly Owned Fully Human Anti-CD19 Antibody, MDX-1342

Date:12/4/2007

Two Separate Clinical Studies Planned for Cancer and Inflammatory Disease

PRINCETON, N.J., Dec. 4 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX) announced today the allowance of two separate investigational new drug applications (IND) filed with the U.S. Food & Drug Administration (FDA) for MDX-1342, one for the treatment of chronic lymphocytic leukemia (CLL) and the other for rheumatoid arthritis. MDX-1342 is a fully human antibody that targets CD19, a molecule specifically expressed on normal B-cells and malignant B-cells in diseases such as CLL, acute lymphoblastic leukemia, follicular non-Hodgkins lymphoma, diffuse large B-cell lymphoma and mantle cell lymphoma.

The IND for the treatment of CLL is for an open-label, multi-dose, dose-escalation Phase I clinical trial for cancer that is expected to enroll up to 52 patients with relapsed or refractory CLL. This trial is designed to establish and evaluate the safety, tolerability and maximum tolerated dose, as well as preliminary pharmacodynamics and efficacy of MDX-1342.

The IND for the treatment of rheumatoid arthritis is for a randomized, single-dose, dose-escalation, placebo-controlled Phase I clinical trial that is expected to enroll up to 90 patients with rheumatoid arthritis. This trial is designed to evaluate the safety and tolerability profile of MDX-1342 and to determine the dose range for B-cell depletion.

"We are pleased with the advancement of a new product candidate from Medarex's proprietary pipeline into clinical trials," said Howard H. Pien, President and CEO of Medarex. "We look forward to the continued development of MDX-1342, which could provide new treatment options for a number of serious conditions."

About
'/>"/>

SOURCE Medarex, Inc.
Copyright©2007 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4
Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
4. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
5. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
6. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
7. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
8. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
9. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
10. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
11. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study

Post Your Comments:

(Date:11/9/2009)..., WALTHAM, Mass., Nov. 9 Decisio...nd advisory firms for pharmaceutical and healthcar...wth factor receptor 2 (HER2) targeting therapies -...SmithKline/Nippon Kayaku,s Tykerb/Tyverb -- were t...atment. Continued uptake of Herceptin and Tykerb/T...

(Date:11/9/2009)..., SUNNYVALE, Calif., Nov. 9 /PRNewswire-FirstCal...harmaceutical company focused on developing and co...the treatment of immune mediated diseases and canc...sident, Preclinical Development will provide an ov... Merriman Curhan Ford,s 6th Annual Investor Summit...

(Date:11/9/2009)..., GLEN ROCK, Pa., Nov. 9 ARmark ...c. announced today an alliance in the development ...M) , an authentication technology that incorporate...-release film coatings of solid oral dosage forms ...ovides Colorcon exclusive rights to market ARmark,...

Breaking Medicine Technology:Sales of HER2-Targeting Agents for Breast Cancer, Including Herceptin and Tykerb/Tyverb, Will Grow by 3.3 Percent Annually from 2008 to 2018 2 Pharmacyclics to Present at Merriman Curhan Ford's Investor Summit 2009 2 ARmark Authentication Technologies, LLC and Colorcon, Inc. Announce Alliance 2 ARmark Authentication Technologies, LLC and Colorcon, Inc. Announce Alliance 3 Study reveals new role of vitamin C in skin protection 56591 1 Study reveals new role of vitamin C in skin protection 56591 2 UAB researchers find TB prevention therapy is cost effective option 56588 1 UAB researchers find TB prevention therapy is cost effective option 56588 2 Lead in bone associated with increased risk of death from cardiovascular disease in men 56585 1 Lead in bone associated with increased risk of death from cardiovascular disease in men 56585 2

[0] Sales of HER2-Targeting Agents for Breast Cancer, Including Herceptin and Tykerb/Tyverb, Will Grow by 3.3 Percent Annually from 2008 to 2018 [0] Pharmacyclics to Present at Merriman Curhan Ford's Investor Summit 2009 [0] ARmark Authentication Technologies, LLC and Colorcon, Inc. Announce Alliance

...ng and Webcast to Follow,Presentation, DANBURY, Co...l,Inc. today announced plans to present clinical r...M), at the 67th Annual American,Diabetes Associati...o, June 22 through June 26. , Biodel,s oral presen...4:15 - 6:15pm CST, a summary of which will be avai...

...wire-FirstCall/ -- Orexigen(TM),Therapeutics, Inc....tment of central nervous system disorders with an ... Company will present data,about its lead obesity ...arkers of cardiovascular disease (visceral fat, se...sistance. The,findings come from additional analys...

Other Medicine Technology:Biodel Inc. to Present VIAject Clinical Progress at the 2007,American Diabetes Association Meeting 2 Biodel Inc. to Present VIAject Clinical Progress at the 2007,American Diabetes Association Meeting 3 Orexigen Therapeutics to Present Data on Contrave Impact on,Visceral Fat and Insulin Resistance at American Diabetes,Association 67th Scientific Sessions in Chicago June 23 2 Orexigen Therapeutics to Present Data on Contrave Impact on,Visceral Fat and Insulin Resistance at American Diabetes,Association 67th Scientific Sessions in Chicago June 23 3

Biodel Inc. to Present VIAject Clinical Progress at the 2007,American Diabetes Association Meeting Orexigen Therapeutics to Present Data on Contrave Impact on,Visceral Fat and Insulin Resistance at American Diabetes,Association 67th Scientific Sessions in Chicago June 23

(Date:11/9/2009)... , Tarkett Sports, the wo...orth American indoor product offering with a more ...ptions, a new team of indoor sports flooring exper.... , (PRWEB) November 9, 2...erican indoor sports flooring products includes ha...

(Date:11/9/2009)... , SHENZHEN, China, Nov. 9 /PRNewswire-As...ited (NYSE: MR ), a leading developer, manufactur...unced today its selected unaudited,financial resul...tember 30,2009. , , Highlights for Operations...9 net revenues were $151.1 million, an increase of...

(Date:11/9/2009)... , WASHINGTON, Nov. 9 The C...estow its Award For Leadership to J.W. "Bill" Marr...cracy through progressive free market practices an...s culture. Mr. Marriott will receive his award at ...he Washington D.C. Four Seasons Hotel. ,, "Thi...

(Date:11/9/2009)... Result may be left atrial enlargement, study fin...- Obesity is a major risk factor for left atrial e...rillation, stroke and death, a new study shows. ,...arrhythmia (an irregular heart rhythm or heartbeat...d women, aged 25 to 74, in Germany who were follow...

(Date:11/9/2009)... Link likely due to fact that both eye conditions...NDAY, Nov. 9 (HealthDay News) -- Cataract surgery ...ated macular degeneration (AMD), according to a ne...ne cause of vision loss worsens the other. , "B...any individuals with cataract also have AMD," wrot...

[0] Tarkett Sports Launches Revamped Indoor Sports Flooring Division and New Indoor Website [0] Mindray Announces Third Quarter 2009 Financial Results [0] J.W. 'Bill' Marriott to Receive Churchill Centre Award For Leadership [0] Obesity Seems to Alter Heart Structure [0] Cataract Surgery Doesn't Worsen Macular Degeneration: Study

... more complete picture of color vision evolution h...li to an up-close, genetic encounter with one of t... , Verrelli and his ASU team have performed the f...al features including extremely large eyes and ear...

...e age of 5 who receive an annual flu shot have a g... or be admitted to the hospital because of flu-rel...of Pediatrics that analyzes how many outpatient vi... as 650,000 doctors office visits and 2,250 hospit...

... 4 "Biotech rode a surging market,in the final tr... Day,holiday weekend," said G. Steven Burrill, CEO...leader in life sciences whose principal activities...SDAQ,s 2% increase." Driving the Burrill Biotech ...

...Sept. 4 Approximately 85,percent of the 8 million...y,Disorder (AD/HD) remain undiagnosed due to a lac... this neurobiological disorder. Without proper,med...g of the disorder and provide hope to,people with ...

...forts to control it, diarrhoea is still one of the...rates in many low and middle-income countries. Thi...nted at the Swedish medical university Karolinska ...any years, Chief physician Birger Forsberg has bee...

...rbett Worldwide Healthcare,Communications has been...udging Event in the U.S. Robin Shapiro, Senior Vic...rbett, will serve as the Host Judge.,Corbett is th... of Corbett.,"The Global Awards is one of the most...

Other Medicine News:Health News:The aye-ayes have it: The preservation of color vision in a creature of the night 2 Health News:The aye-ayes have it: The preservation of color vision in a creature of the night 3 Health News:Annual flu shot cuts need for doctors' visits, hospitalization among children 2 Health News:Biotech Finishes on a High in August, Burrill Report Says 2 Health News:Biotech Finishes on a High in August, Burrill Report Says 3 Health News:Biotech Finishes on a High in August, Burrill Report Says 4 Health News:Biotech Finishes on a High in August, Burrill Report Says 5 Health News:ADDA'S Awareness Campaign Offers Resources and Education to Adults Living with AD/HD and Professionals Working With Them 2 Health News:ADDA'S Awareness Campaign Offers Resources and Education to Adults Living with AD/HD and Professionals Working With Them 3 Health News:1.5 million children could be saved 2 Health News:Corbett Selected to Host the Only Midwest Global Awards Judging Competition 2

The aye-ayes have it: The preservation of color vision in a creature of the night Annual flu shot cuts need for doctors' visits, hospitalization among children Biotech Finishes on a High in August, Burrill Report Says ADDA'S Awareness Campaign Offers Resources and Education to Adults Living with AD/HD and Professionals Working With Them 1.5 million children could be saved Corbett Selected to Host the Only Midwest Global Awards Judging Competition

AQuify Long-Lasting Comfort Drops

Lens Plus Rewetting Drops

Renu Rewetting Drops

Renu Multiplus Lubricating and Rewetting Drops

Medicine Products:

AQuify Long-Lasting Comfort Drops Lens Plus Rewetting Drops Renu Rewetting Drops Renu Multiplus Lubricating and Rewetting Drops

Medarex Announces Allowance of Investigational New Drug Applications for Wholly Owned Fully Human Anti-CD19 Antibody...( Two Separate Clinical Studies Planne...),Health