GNTA.OB...Sector: Healthcare...Industry: Biotechnology & Drugs

[D&Data]

Hi Setravis,everybody

Genta found a nice support between 0.70 - 0.8.

Note this in your agenda :

The Company requested a meeting with the FDA and submitted additional data analyses in support of the NDA. On October 30, 2006, the Company announced that the FDA determined that the new information constituted a major amendment to the NDA and extended the review period for ninety days to January 29, 2007

If the FDA is ok...this could be a really big gainer !
remember :
http://money.cnn.com/2006/08/30/news/companies/fda/index.htm?source=yahoo_quote

Its product Genasense, designed to block the production of a protein known as Bcl-2, which is used for the treatment of malignant melanoma, chronic lymphocytic leukemia, multiple myeloma, acute myelocytic leukemia, nonsmall-cell lung cancer, prostate cancer, small-cell lung cancer, breast cancer, colorectal cancer, nonHodgkin's lymphoma, kidney cancer, pancreatic cancer, Waldenstrom's macroglobulinemia, hepatocellular carcinoma, and childhood solid tumors

Now...wait FDA's decision ...you've got the time to trade

[D&Data]

Hi,

[D&Data]

clinical benefit correlates with major objective response (GNTA) 0.65 : Co announces the presentation of data that support major objective response as a key endpoint for clinical trials in patients with relapsed or refractory chronic lymphocytic leukemia. The analyses derive from the co's pivotal Phase 3 trial of chemotherapy with or without Genasense Injection, co's lead anticancer drug. Results of these analyses show that CR/nPR was associated with both durable and complete relief of CLL signs and symptoms. By contrast, the relief observed in patients who achieved only partial response was significantly inferior and less sustained. Moreover, patients who failed to achieve at least a PR derived very little benefit. Co says the investigators concluded that lack of disease progression absent achievement of a major objective response was not associated with important clinical benefit in this population. The data were presented Monday at the annual meeting of the American Society of Hematology.


Not in yet but plan to do ...
...

[D&Data]

Ola..
Macd has shown good signs...
GNTA has no news but volmes are driving the pps up...is there a solid news around the corner ?

[traderjbr]

This one appears to have started an upward correction recently.Some indicators turning bullish:Macd pos divergence and crossing centerline,price broke above upper Bollinger Band and back near its centerline,price broke above 50 day ma,pos shift in Parabolic SAR, ADX(14) breaking out from a recent convergence below 20,higher highs and higher lows in the RSI(14),OBV recent break over its 20ma,weekly fast stoch's- fast crossing slow and coming up thru 20 and on an even shorter time frame price closed on lower channel line support 60 min chart 10 day channel.This is going to need some strong VOLUME to make a meaningful move higher imo..

[Ares]

http://www.3stocksonfire.org/trading/index.php?topic=8896.msg97445#msg97445

[stockpicker]

Took a very small (long) position at 33-34 cents

[Ares]

GNTA became GNTAD.
From 0.29 to  today's high of 1.71?

[setravis]

Buying here !
Stocks under $1.00...but too many times I have seen them reach $1.00 again !
Looks oversold, positive money flow increasing, MACD reversing, all looks good, shows good support at 0.80...Should go up without news, and surge on speculation of European approval.


Technicals
Last Price Quote is:
21.00%above 13-day MA
71.81%above 50-day MA
RS Rating: 99 

Fundamentals
Key Data:
Market Cap (M): $26.03 
P/E Ratio: 388.89 
PEG Ratio: N/A 
Next Earnings: 11/06/2007
Last Analyst Rating: Hold

[setravis]

Press Release Source: Genta Incorporated


Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
Wednesday September 5, 8:00 am ET 
Barcelona Hosts Key Investigator Meeting for European Participants in Phase 3 AGENDA Trial Targeting Biomarker-Defined Population


BERKELEY HEIGHTS, N.J., Sept. 5 /PRNewswire-FirstCall/ - Genta Incorporated (Nasdaq: GNTA - News) announced that data from the Company's Phase 3 trial of Genasense® (oblimersen sodium) plus chemotherapy would be presented at the opening session of the first Worldwide Melanoma Center Meeting organized by the European Association of Dermato-Oncology (EADO). Genta, which is a Silver Level sponsor of the EADO meeting, will also host its key investigator meeting for European participants in the Company's ongoing Phase 3 trial of Genasense in advanced melanoma. The Genasense clinical results will be presented by Dr. Claus Garbe, who is Chair of the Congress, and Professor of Dermatology and Head of the Division of Dermatooncology, Department of Dermatology, University Medical Center, Tubingen, Germany. The EADO, which is the lead international cooperative group for the current Phase 3 trial, is meeting this week in Barcelona, Spain.


The new Genasense trial, known as AGENDA, is a randomized, double-blind, placebo-controlled study in which patients are randomly assigned to receive Genasense plus dacarbazine (DTIC) or DTIC alone. AGENDA is designed to confirm the safety and efficacy of Genasense when combined with DTIC in patients who have not previously received chemotherapy. The trial will accrue approximately 300 patients who have been defined using a biomarker and will be conducted at approximately 100 sites worldwide, including North America, Europe and Australia. Patient enrollment into AGENDA has been initiated.

About Genasense in Advanced Melanoma

Genasense, Genta's lead anticancer drug, is a novel targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of cancer treatment resistance. By knocking down Bcl-2, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma. Genasense in melanoma has Orphan Drug designations in Australia and the U.S., along with Fast Track designation in the U.S.

In its initial Phase 3 trial, Genta performed the largest randomized controlled trial that has ever been conducted in patients with advanced melanoma. In that trial, 771 patients were randomly assigned to receive chemotherapy with DTIC alone or in combination with Genasense. A scientific article that describes efficacy and safety results from this study can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1.

In that trial, patients were prospectively stratified according to levels of a blood enzyme known as LDH. Further analysis of this study showed that maximum benefit accrued to patients whose LDH biomarker did not exceed 80% of the upper limit of normal. Efficacy results in this group of 274 patients, which are the focus of the confirmatory AGENDA trial, are displayed in the table below. (The hazard ratios indicate that the addition of Genasense to DTIC was associated with a 42% reduction in the risk of disease progression and a 36% reduction in risk of death.)




    Endpoint                Genasense/DTIC   DTIC         Hazard      P
                                                          Ratio
    Overall response             20.8 %      7.2 %                  0.002
    Durable response             10.7 %      2.4 %                  0.007
    Progression-free survival,
     median                     3.6 mos.     1.6 mos.     0.58     <0.0001
    Overall survival, median   12.3 mos.     9.9 mos.     0.64      0.0009


About Melanoma

Malignant melanoma is the most deadly form of skin cancer. The incidence of this disease is increasing by approximately 4% annually in the U.S. In 2004, the American Cancer Society estimates more than 55,000 cases of malignant melanoma will have been diagnosed. Melanoma is the number one cause of cancer death in women aged 25 to 29. More information about melanoma can be accessed at the Melanoma Research Foundation: http://www.melanoma.org.

About the EADO

The EADO is an international cooperative group dedicated to promote, coordinate and improve clinical and laboratory research activities in skin cancer. Further information about the EADO can be viewed at: http://www.eado.org/.

About Genta

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company's research platform is anchored by two major programs that center on oligonucleotides (RNA- and DNA- based medicines) and small molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its oligonucleotide program. The leading drug in Genta's small molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. Genta is partnered with IDIS (www.idispharma.com) on a program whereby both Ganite® and Genasense® are available on a "named- patient" basis in countries outside the United States. For more information about Genta, please visit our website at: www.genta.com.

Safe Harbor

This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Forward- looking statements include, without limitation, statements about:


    -- the Company's ability to obtain necessary regulatory approval for
       Genasense® from the U.S. Food and Drug Administration ("FDA") or
       European Medicines Agency ("EMEA");
    -- the safety and efficacy of the Company's products or product
       candidates;
    -- the Company's assessment of its clinical trials;
    -- the commencement and completion of clinical trials;
    -- the Company's ability to develop, manufacture, license and sell its
       products or product candidates;
    -- the Company's ability to enter into and successfully execute license
       and collaborative agreements, if any;
    -- the adequacy of the Company's capital resources and cash flow
       projections, and the Company's ability to obtain sufficient financing
       to maintain the Company's planned operations;
    -- the adequacy of the Company's patents and proprietary rights;
    -- the impact of litigation that has been brought against the Company and
       its officers and directors and any proposed settlement of such
       litigation; and
    -- the other risks described under Certain Risks and Uncertainties Related
       to the Company's Business, as contained in the Company's Annual Report
       on Form 10-K and Quarterly Report on Form 10-Q.

The Company does not undertake to update any forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2006 and its most recent quarterly report on Form 10-Q.


    CONTACT:
    For Genta Incorporated
    Tara Spiess
    TS Communications Group, LLC
    (908) 286-3980
    [email protected]
--------------------------------------------------------------------------------
Source: Genta Incorporated

[setravis]

Resurrection for GNTA.......

52wk Range: 0.75 - 6.60
Volume: 1,704,821
Avg Vol (3m): 287,332

Technicals
Percentage Gainer

Last Price Quote is:
46.12%above 13-day MA
114.62%above 50-day MA
RS Rating: 99 

Fundamentals
Key Data:
Market Cap (M): $26.03 
P/E Ratio: 388.89 
PEG Ratio: N/A 
Next Earnings: 11/06/2007
Last Analyst Rating: Hold
 

[traderjbr]

Another pop today,may have to keep a watch this one..

[traderjbr]

Fresh news,macd, obv, breaking out here,stock staging a turnaround.

[setravis]

AP
Shares of Genta Climb on Trial Launch
Monday September 17, 1:32 pm ET 
Shares of Biotech Genta Climb on Trial Launch for Oral Drug to Treat Bone Disease


NEW YORK (AP) -- Shares of Genta Inc. rose sharply Monday after the biotechnology company said it started the first clinical trial of its oral drug to treat bone disease.
Genta said the first cohort of six volunteers has been treated with single doses of G4544 without experiencing significant side effects.


G4544 is a tablet formulation of the injected drug Ganite, which Genta markets for treatment of a form of cancer-related hypercalcemia, or high blood calcium levels.

The initial clinical study of G4544 in humans will examine safety and pharmacokinetics, or how the body uses the drug.

The study also will seek to establish bioequivalence with Ganite, the company said. Bioequivalence is a regulatory requirement that the active ingredient of a drug be absorbed and metabolized in the body in about the same amount, over about the same time, as the active ingredient of a brand name drug, like Ganite.

Genta also said the Food and Drug Administration allowed an investigational new drug exemption for G4544.

The news sent shares of Genta up 8 cents, or 6.3 percent, to $1.36 in midday trading at more than quadruple their average daily volume. The stock has traded between 75 cents and $6.60 in the past year.

[setravis]

Press Release Source: Genta Inc.


Genta Initiates First Clinical Trial with New Oral Drug (G4544) to Treat Bone Disease
Monday September 17, 8:05 am ET 
IND Allowed by FDA for Bioequivalence Program Starting in Normal Volunteers


BERKELEY HEIGHTS, N.J., Sept. 17 /PRNewswire-FirstCall/ -- Genta Inc. (Nasdaq: GNTA - News) announced that the Food and Drug Administration (FDA) has allowed the Investigational New Drug (IND) exemption that was submitted by the Company for its new drug known as G4544. In addition, Genta also announced that the first cohort of 6 normal volunteers has been treated with single doses of G4544 without experiencing significant side effects.


G4544 is a new tablet formulation that enables oral absorption of the active ingredient contained in Ganite® (gallium nitrate injection), a drug that is marketed by Genta and approved in the U.S. for treatment of cancer- related hypercalcemia that is resistant to hydration. The initial clinical study is a dose-ranging, single-dose evaluation of G4544 that will examine safety and pharmacokinetics of G4544 in human subjects. Genta is the IND Sponsor and is directing the clinical development program.

"The active ingredient in G4544 has shown a consistently high level of clinical activity across a range of skeletal diseases," said Dr. Raymond P. Warrell, Jr., Chairman and Chief Executive Officer of Genta. "Heretofore, an inconvenient dosing schedule has precluded broader use of the IV drug, which may now be resolved with the new oral formulation. We believe that emerging safety issues, such as osteonecrosis, that have been associated with the major competitive drug class of bisphosphonates, can be avoided with G4544. From a regulatory standpoint, we seek to establish bioequivalence to our IV drug, while conducting the additional preclinical and clinical studies to develop repeat-dose programs that may lead to rapid approval in hypercalcemia. We also foresee the potential for subsequent approvals in other diseases, such as non-Hodgkin's lymphoma, bone metastases, Paget's disease, and osteoporosis. Genta plans to manage the G4544 development program in oncology, and we intend to seek a partner for clinical programs in metabolic bone disease."

Gallium-Containing Compounds

G4544 is one of a class of gallium-containing compounds that were originally developed by the U.S. National Cancer Institute. In investigational studies, high doses of gallium nitrate demonstrated consistent antitumor activity in patients with non-Hodgkin's lymphoma. However, experimental work by Genta personnel and others established that lower doses of gallium directly inhibited calcium release from bone, principally by decreasing bone resorption and possibly by also stimulating bone formation.

Many diseases are associated with accelerated bone loss, including osteoporosis, cancer, and Paget's disease. In some diseases, the rate of loss is slow and subtle, while in others the rate is rapid and acutely life- threatening. In osteoporosis, the most prevalent bone-losing condition, the process of bone loss extends over many years before the disease becomes evident. Conversely, in cancer-related hypercalcemia, bone loss is so rapid that it overwhelms the kidney's ability to eliminate calcium from the blood, and this condition can quickly become lethal. In patients with cancer-related hypercalcemia who were resistant to hydration, randomized double-blind trials have been conducted with Ganite compared with calcitonin and with two bisphosphonates (etidronate [Didronel®; Proctor and Gamble] and pamidronate [Aredia®; Novartis, Inc.]).

About G4544

G4544 was developed to enable extended administration of the active ingredient in Ganite, which may greatly improve patient convenience and avoid the current need for intravenous pumps or hospitalization. The initial focus of clinical studies with G4544 will be to establish its bioequivalence with the intravenous product, potentially enabling rapid regulatory approval of the oral formulation. Genta holds or has exclusively licensed the intellectual property related to G4544.

About Genta

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company's research platform is anchored by two major programs that center on oligonucleotides (RNA- and DNA- based medicines) and small molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its oligonucleotide program. The leading drug in Genta's small molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. Genta is partnered with IDIS (www.idispharma.com) on a program whereby both Ganite® and Genasense® are available on a "named- patient" basis in countries outside the United States. For more information about Genta, please visit our website at: www.genta.com.

Safe Harbor

This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Forward- looking statements include, without limitation, statements about:


    -- the Company's ability to obtain necessary regulatory approval for
       Genasense® from the U.S. Food and Drug Administration ("FDA") or
       European Medicines Agency ("EMEA");
    -- the safety and efficacy of the Company's products or product
       candidates;
    -- the Company's assessment of its clinical trials;
    -- the commencement and completion of clinical trials;
    -- the Company's ability to develop, manufacture, license and sell its
       products or product candidates;
    -- the Company's ability to enter into and successfully execute license
       and collaborative agreements, if any;
    -- the adequacy of the Company's capital resources and cash flow
       projections, and the Company's ability to obtain sufficient financing
       to maintain the Company's planned operations;
    -- the adequacy of the Company's patents and proprietary rights;
    -- the impact of litigation that has been brought against the Company and
       its officers and directors and any proposed settlement of such
       litigation;  and
    -- the other risks described under Certain Risks and Uncertainties Related
       to the Company's Business, as contained in the Company's Annual Report
       on Form 10-K and Quarterly Report on Form 10-Q.

The Company does not undertake to update any forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2006 and its most recent quarterly report on Form 10-Q.

    CONTACTS:

    For Genta Incorporated
    Tara Spiess
    TS Communications Group, LLC
    (908) 286-3980
    [email protected]
--------------------------------------------------------------------------------
Source: Genta Inc.