Navigation Links
Genta Incorporated Announces Fourth Quarter and Year End 2007 Financial Results and Corporate Highlights
Date:3/12/2008

termittent dosing by both subcutaneous injection and brief (1-2 hour) intravenous (IV) infusion. The maximally tolerable dose (MTD) on a once-per-week for 3 weeks schedule was identified. The follow-on study using the MTD administered on a twice-per- week for 3 weeks schedule has also been completed.

Genta expects to incorporate this new schedule into the ongoing melanoma trial with Abraxane(R) and Temodar(R). These new schedules may ultimately obviate the need for treatment via continuous IV infusion. Abstracts describing results of these studies have been submitted to the 2008 ASCO meeting.

G4544, A New Oral Drug for Skeletal Diseases, Enters Clinical Trials

In late 2007, Genta completed the initial Phase 1 study of G4544, the Company's proprietary small molecule that is intended to treat diseases associated with accelerated bone loss. G4544 contains the active ingredient in Ganite(R), a highly effective drug whose market potential has been constrained by a requirement for continuous IV infusion. No drug-related adverse experience was observed in 30 subjects who received G4544 over a 5- fold dosing range. Further clinical and pharmacokinetic results have been submitted to the 2008 ASCO meeting.

G4544 Development Strategy: The Company has improved the G4544 manufacturing process. Following review and approval of this change, Genta will seek FDA guidance on the 505(b)(2) regulatory pathway, which may shorten development time by allowing use of bioequivalence studies rather than trials to demonstrate efficacy and safety. In this case, Genta owns the NDA for Ganite and has exclusive ownership of important trade secrets, including but not limited to detailed pharmacokinetics and long-term animal toxicology of the active ingredient. The 505(b)(2) approach enables potential approval in the currently approved indication (cancer-related hypercalcemia), in parallel with development in other indications. Low doses of the active ingredient have als
'/>"/>

SOURCE Genta Incorporated
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10

Related medicine technology :

1. Innocoll Announces Dosing of First Patient in Second US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections
2. Innocoll Announces Dosing of First Patient in US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections in Cardiac Surgery Patients
3. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Mildly Infected Diabetic Foot Ulcers
4. Genta Clinical Programs Featured at American Society of Hematology Meeting
5. Genta Completes Initial Clinical Dosing of G4544, a New Oral Drug for Bone Diseases
6. Genta Incorporated Announces Third Quarter 2007 Financial Results
7. Genta Initiates First Clinical Trial with New Oral Drug (G4544) to Treat Bone Disease
8. Genta Initiates Phase 3 AGENDA Trial of Genasense(R) for Patients with Advanced Melanoma
9. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
10. Progen Announces Commencement of Global Phase 3 Study for PI-88 in Post- Resection Liver Cancer
11. Inclinix Announces New Patent for Expert System Platform
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... /CNW/ - Protecting the health and safety of Canadians is our ... appropriate powers and tools at its disposal to help ensure that ... To that end, Health Canada ... Canada of all drug products from three ... , Apotex Pharmachem India Pvt Ltd , Apotex ...
(Date:9/30/2014)... , Sept. 30, 2014  Hologic, Inc. (NASDAQ: ... , Hologic,s President and Chief Executive Officer, will preside ... October 1, the first day of Breast Cancer Awareness ... Company,s campaign focused on the important benefits of Hologic,s ... the FDA as clinically superior to traditional mammography. ...
(Date:9/30/2014)... LONDON , Sept. 30, 2014 ... market for molecular imaging informatics solutions including nuclear ... fusion and comparison. The study assesses the size ... between 2010 and 2013, and projects future growth ... well as the dynamics taking place in the ...
Breaking Medicine Technology:Statement by the Honourable Rona Ambrose on the import ban of drug products from three plants in India 2Hologic to Kick Off National Breast Cancer Awareness Month at the October 1 NASDAQ Stock Market Opening Bell Ceremony 2Hologic to Kick Off National Breast Cancer Awareness Month at the October 1 NASDAQ Stock Market Opening Bell Ceremony 3Analysis of the US Molecular Imaging Informatics Market 2Analysis of the US Molecular Imaging Informatics Market 3
(Date:9/30/2014)... no genetic evidence that high levels of vitamin D ... Some previous research had suggested that elevated levels ... diabetes, raising the possibility of a link between vitamin ... this study, British researchers investigated the association between diabetes ... control blood levels of vitamin D. They found no ...
(Date:9/30/2014)... plant standards to cut climate-changing carbon emissions will ... human health benefits, according to a new study ... the policy options included in the final Clean ... thousands of premature deaths and hospitalizations, and hundreds ... year., In the new study, Health Co-benefits of ...
(Date:9/30/2014)... cancer, breast cancer is the leading cause of cancer ... That,s why so many medical professionals encourage women to ... best: only a minority of suspicious mammograms actually leads ... of needless worry for women and their familiesnot to ... including ultrasounds and biopsies. , Recently, a different ...
(Date:9/30/2014)... Utah (PRWEB) September 30, 2014 A new ... Ohio State University studied the impact of stress on metabolism ... burger and french fries from a fast food restaurant, about ... woman’s resting metabolism for 20 minutes every hour for 7 ... Results showed that women who had experienced a stressful event ...
(Date:9/30/2014)... Research by UC Irvine immunologists reveals new information ... a vital process that determines how the body,s ability ... of Nature Immunology , neurology professor Dr. Michael ... Immunology colleagues describe a critical mechanism underlying how T ... , A T cell is a type of blood ...
Breaking Medicine News(10 mins):Health News:Gene Study Finds No Proof Vitamin D Guards Against Type 2 Diabetes 2Health News:Power plant standards could save thousands of US lives every year 2Health News:Power plant standards could save thousands of US lives every year 3Health News:'Virtual breast' could improve cancer detection 2Health News:NutriGold Urges Every Woman To Read a Recent Study About Diet and Stress 2Health News:NutriGold Urges Every Woman To Read a Recent Study About Diet and Stress 3Health News:UCI study uncovers important process for immune system development 2
... Lung Association Urges Senate to Quickly Pass this ... Charles D. Connor, American Lung Association President and ... overwhelmingly voted in favor with a strong bipartisan ... to pass the Family Smoking Prevention and Tobacco ...
... Mo., April 2 Argus Health Systems, Inc., a ... an award from the Flaspohler Research Group as the ... Interest" in the 2008 PBM Survey of MCOs ... by survey participants based on specific attributes, including not ...
... always see what is in front of us? According to ... The City College of New York (CCNY), the answer is "no." ... by Professor Ro and colleagues from the University of Illinois demonstrates ... a trough. , "We may have our eyes open, but we ...
... attention about clinical productivity and adoption of Health IT ... www.usercentric.com ) - a user research firm based in ... healthcare industry called Usability Diagnostics ... targeted for these service offerings are: Electronic Health Records ...
... PHILADELPHIA, April 2, 2009 -- More than 6,000 ... allied health professionals will meet in Philadelphia for ... the American College of Physicians (ACP), April 23 ... Convention Center. , ACP is the largest specialty ...
... ALTO, Calif., April 2 Varian Medical Systems (NYSE: ... anniversary and a decade of growth and innovation in ... and security and inspection. , , Varian ... 2, 1999 following the division of Varian Associates, a ...
Cached Medicine News:Health News:U.S. House of Representatives Again Votes with a Strong Bipartisan Majority in Favor of Granting the U.S. FDA Regulatory Control Over Tobacco Products 2Health News:Argus Honored by Flaspohler Research Group as Highest-Rated PBM for 'No Conflicts of Interest' 2Health News:Neuroscientists demonstrate link between brainwave acticity and visual perception 2Health News:User Centric Offers New Service, Usability Diagnostics, to Measure HIT Usability 2Health News:User Centric Offers New Service, Usability Diagnostics, to Measure HIT Usability 3Health News:From the ethics of Dr. Frankenstein to preventing cardiovascular disease 2Health News:From the ethics of Dr. Frankenstein to preventing cardiovascular disease 3Health News:From the ethics of Dr. Frankenstein to preventing cardiovascular disease 4Health News:From the ethics of Dr. Frankenstein to preventing cardiovascular disease 5Health News:Varian Medical Systems to Celebrate Tenth Anniversary and Decade of Growth 2Health News:Varian Medical Systems to Celebrate Tenth Anniversary and Decade of Growth 3
Advanced operating microscope with high-resolution apochromatic optics. Senso-servo drive to keep the microscope in perfect balance even if parts are moved or mounted elsewhere....
The Horizontal-Vertical (H/V) lumbar valve system is the only differential pressure valve for lumbo-peritoneal shunting, which addresses orthostatic overdrainage....
10 overall length 4.5 from bend 250 mm. 90...
Wilson pituitary forcep, flattened tip, 3 mm bite, 145 mm effective....
Medicine Products: