Stockmarketquarterly Newsletter GNTA

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Genta Incorporated
200 Connell Drive
Berkeley Heights, NJ 07922
Phone: 908-286-9800
Fax: 908-464-1701

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. Two major programs anchor the Company’s research platform : DNA/RNA-based Medicines and Small Molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genta is currently recruiting patients to the AGENDA Trial , a global Phase 3 trial of Genasense in patients with advanced melanoma.

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. The Company has developed G4544, an oral formulation of the active ingredient in Ganite, that has recently entered clinical trials as a potential treatment for diseases associated with accelerated bone loss. The Company is also developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drug as paclitaxel and docetaxel. Ganite® and Genasense® are available on a “named-patient” basis in countries outside the United States.

Ganite^® is indicated for the treatment of clearly symptomatic cancer-related hypercalcemia that has not responded to adequate hydration. In general, patients with a serum calcium concentration (corrected for albumin) < 12 mg/dL would not be expected to be symptomatic.

Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without diuretics). In the treatment of cancer-related hypercalcemia, it is important first to establish adequate hydration, preferably with IV saline, in order to increase the renal excretion of calcium and correct dehydration caused by hypercalcemia.

Genta has built a broad portfolio of proprietary products in various stages of clinical development. The Company’s lead compound, Genasense® (oblimersen sodium) Injection, has been studied in over 2300 patients with a wide variety of tumor types. At Genta, we are aggressively leveraging our expertise in clinical oncology research by expanding and diversifying our R&D pipeline.

Genta is building a portfolio of products targeted against some of the most deadly diseases and conditions facing patients with cancer today. With four products in the pipeline and on-going clinical trials in all phases of development (Preclinical to Phase III), Genta is committed to better the lives of people with cancer.

Genta’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 oligonecleotide program. The leading drug candidate from the small molecule program is G4544. This compound has the same active ingredient as Ganite (gallium nitrate) Injection, a product currently marketed by Genta. G4544 represents the successful reformulation of the clinically active ingredient into a tablet formulation that can be taken by mouth for extended periods. The IND proposes a dose-ranging trial of G4544 in normal volunteers that will examine safety and pharmacokinetics providing a rapid path to regulatory approval.

The AGENDA Trials

The AGENDA Trial is the second randomized Phase 3 trial in advanced melanoma for Genasense®. The trial is designed to expand evidence for the safety and efficacy of Genasense® combined with dacarbazine for patients who have not previously been treated with chemotherapy. The study will prospectively target patients using a biomarker that identified patients who derived maximal benefit in the preceding trial of Genasense®, including significant increases in overall and progression-free survival.

Genasense® (oblimersen sodium) Injection - ADVANCED MELANOMA

In its initial trial, Genta performed the largest randomized controlled trial that has ever been conducted in patients with advanced melanoma. The melanoma trial was a front-line trial conducted in patients who had not previously received systemic chemotherapy (prior immunotherapy was allowed.) A total of 771 patients were randomized to receive Genasense® (oblimersen sodium) Injection plus dacarbazine (DTIC) or dacarbazine alone. The primary end-point of the study was overall survival; secondary end-points included overall response and progression-free survival (PFS).

Tesetaxel

Tesetaxel is a novel oral semi-synthetic taxane. Taxanes, such as paclitaxel (Taxol®) and docetaxel (Taxotere®), are mainstays of modern anticancer therapy. These drugs are believed to kill cancer cells by disrupting critical cellular proteins. Taxanes have been formally approved by FDA for the treatment of breast, lung, ovarian, gastric, and prostate cancers. However, all currently approved taxanes require intravenous (IV) infusion under close medical supervision. Moreover, both paclitaxel and docetaxel can cause severe, occasionally fatal, infusion reactions, which require pre-medication with steroids and antihistamines. Other serious reactions associated with taxanes include long-lasting damage to peripheral nerves (neuropathy). An oral taxane with the anticancer activity of the IV drugs could provide substantially greater patient safety (by eliminating infusion reactions and precluding the need for pre-medication), a high level of patient convenience, and potentially greater flexibility to explore novel dosing schedules that might improve overall outcomes for patients.

In preclinical testing, tesetaxel has shown clear anticancer activity, including activity against cancer cells that were resistant to paclitaxel and docetaxel. Typically, cancer cells become resistant to taxanes by a mechanism known as “multidrug resistance” that is mediated by a factor called p-glycoprotein. Resistance to tesetaxel did not appear to be mediated by this mechanism, suggesting that tesetaxel might be useful for diseases that are resistant to conventional taxanes.

To date, oral tesetaxel has been studied in Phase 1 and Phase 2 studies involving more than 250 patients. Objective clinical responses have been observed, no patients have developed hypersensitivity effects that have been associated with IV infusion reactions, and no patients have required pre-medication. Unlike other IV taxanes (as well as other investigational oral taxanes), tesetaxel has not been associated with serious nerve damage, which can be quite disabling. However, like all other taxanes, the most serious side-effects of tesetaxel have included lowering of the white blood cell count (neutropenia), and complications of this reaction have been fatal in some patients. Because of this reaction, the Food and Drug Administration (FDA) placed tesetaxel on “clinical hold” and requested further specific information in order to lift the clinical hold and allow patient testing to resume. Genta is currently compiling that information for the FDA.

Oral Gallium Compound (G4544)

The initial clinical trial of G4544, currently pending review, will examine safety and pharmacokinetics of a range of G4544 doses in normal volunteers. High IV doses of gallium nitrate (Ganite®) are extremely effective for treatment of patients (pts) with cancer-related hypercalcemia, and preliminary studies have shown consistent anticancer activity in pts with relapsed non-Hodgkin’s lymphoma (NHL). In preclinical studies, low concentrations of gallium nitrate act as a potent inhibitor of osteoclast-mediated bone resorption, and the agent may also have anabolic effects on bone formation.

Clinical studies have shown that low doses of gallium nitrate administered by subcutaneous injection significantly reduced metabolic markers of disordered bone turnover in patients with advanced Paget’s disease. Moreover, a multi-year longitudinal study in pts with advanced multiple myeloma showed that similarly low doses administered by intermittent subcutaneous injection significantly reduced bone loss in pts receiving chemotherapy. Since gallium nitrate has low oral bioavailability, and in order to improve dosing convenience over extended periods, we have developed a novel formulation of gallium nitrate, known as G4544, which has now advanced into initial clinical studies.

An IND has been filed in the U.S. and initial clinical trials with G4544 are planned for the third quarter of 2007. These trials will seek to establish the bioequivalence of G45644 to Ganite® and to eventually secure regulatory approval for this new drug in patients with cancer-related hypercalcemia. The drug may also be developed for other oncology indications by Genta, and the Company will seek a partner to develop G4544 in other diseases, such as osteoporosis and Paget’s disease.

Certain things have happened for this drop.. As with most Bio companies, results come with FDA approval and continued clinical and new product introduction.. In this case and event in mid-December was the decline in their flagship Genasense(R) on 12/02/08 announced that the Company has received a complete response letter from the Office of Oncology Drug Products (OODP) at the Food and Drug Administration (FDA) regarding the Company's amended New Drug Application (NDA) for the use of Genasense(R) plus chemotherapy in patients with chronic lymphocytic leukemia (CLL). In its letter, OODP indicated that the Division cannot approve the NDA in its present form and suggested the need for an additional clinical study.

The company has much going for it and in my opinion we should eventually get back above .01 as these negative events are behind us. As with many Bio-companies and especially ones that are in continued R&D, you MUST watch the Share Structure.. The company from it's latest 10-Q (11/06/08) mentioned only 36,700,000 Share Outstanding.. When one just looks at the volume over the last month since the drop, I can almost assure you that the Share Structure has drastically increased and if I had to put a count on it now, I expect we have about 200 million currently O/S.. Now this is just my opinion, but with almost 2 billion shares traded since the drop and not all is in shorting or folks bailing because the company didn't meet the FDA approval. No, the company is selling shares or shares for services rendered from 3rd parties, but certainly the O/S must be higher.. Again all my opinion. I tried getting share structure on this issue and it's difficult.

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