|
|
200 Connell Drive,
Berkeley Heights, NJ 07922 USA
phone:(908) 286-9800
fax:(908) 464-1701
|
|
| Symbol |
GNTA.OB |
| Exchange |
OTC BB |
| Founded |
1988 |
| Employees |
20 |
|
|
| www.genta.com
|
|
| Research Sector |
Biotech Specialty Pharma |
|
 |
| Summary Description |
| Cancer treatments |
|
| Management |
| Raymond P. Warrell, Jr., M.D, Chairman of the Board and Chief Executive Officer; Loretta M. Itri, M.D., F.A.C.P, President, Pharmaceutical Development and Chief Medical Officer; Gary Siegel, Vice-President, Finance; Edward C. Spindler, Jr.,
Associate Vice President, Project Management and Technology Development; Jane Z. Wu, Ph.D.,
Associate Vice President, Data Management and Statistics; Janet Ehlert,
Associate Vice President, Regulatory and Medical Writing |
| |
|
|
|
|
|
|
|
| Keywords |
| tesetaxel, gastric, Ganite, hypercalcemia, bone loss. Biopharmaceutical, cancer |
|
|
|
| Description |
|
Genta Incorporated is a biopharmaceutical company with a broad portfolio of proprietary oncology products that are in various stages of clinical development. The Company markets Ganite®, which is indicated for the treatment of cancer-related hypercalcemia, a serious metabolic disorder that occurs in 10% to 20% of all cancer patients and causes the rate at which bone calcium is lost to become so rapid that the blood concentration of calcium increases to levels that are acutely life-threatening if left untreated. It is believed that Ganite® exerts a hypocalcemic effect by inhibiting calcium resorption from bone, and possibly by strengthening the bone itself. This later-stage biotechnology company is currently developing Tesetaxel, a novel oral semi-synthetic taxane; taxanes are believed to kill cancer cells by disrupting critical proteins that maintain the structure of cancer cells, and preclinical studies have shown that Tesetaxel inhibits cell reproduction among cancer cells with greater efficiency than taxanes currently marketed. |
|
| Products / Services |
Tesetaxel is the leading oral taxane in clinical development. The drug offers several key advantages:
Convenient oral dosing; no hypersensitivity infusion reactions, which eliminates requirements pre-medications, extended medical/nursing observation, and prolonged IV infusions;
low incidence of peripheral neuropathy, a disabling effect that limits cumulative dosing; activity in taxane-resistant cancers;
flexible dosing schedules that may enhance efficacy and use in multi-drug combinations.
Tesetaxel has completed 5 Phase 1 studies, and 5 Phase 2 studies. High response rates were observed in patients with advanced breast and gastric cancer (38% and 20%, respectively). Genta has initiated 6 Phase 2a or confirmatory 2b clinical trials in 5 discrete indications (gastric, bladder, breast and prostate cancer, and melanoma). To date, more than 350 patients have been treated with Tesetaxel.
The Company has announced that gastric, breast, and prostate cancer are priority indications, and that gastric cancer will be the lead registration indication. A randomized, placebo-controlled Phase 3 protocol in 2nd-line gastric cancer has been designed, which has completed the ?Scientific Advice? process at EMA. Results from the confirmatory breast cancer study showed an overall major response rate > 50%. Neutropenia was the dose-limiting adverse event, and no hypersensitivity reactions were observed.
Gallium compounds are comprised of the active ingredient in the Company's marketed product, Ganite, which is approved in the U.S. for treatment of cancer-related hypercalcemia that is resistant to hydration. The active ingredient prevents bone loss by blocking the action of osteoclasts, and certain preclinical data suggest the agent may also have anabolic (bone-building) activity. Low doses of the active ingredient have already demonstrated clinical "proof-of-concept" in patients with bone metastases, Paget's disease, and osteoporosis. Such low-dose treatment over an extended period may maintain bone integrity and prevent complications associated with loss of bone mass, such as fractures and pain. Given the different mechanism of action, gallium compounds may be associated with fewer complications than those associated with the long-term use of bisphosphonates and denosumab, such as osteonecrosis. Genta has developed several orally available compounds containing the active ingredient and expects to select a lead compound for IND filing during 2011.
|
|
| Technology / Differentiation |
| The Small Molecules Program at Genta is focused on developing novel agents that represent important advances in oncology therapeutics. Tesetaxel, the lead agent from this Program and the leading oral taxane currently in clinical trials, is at the late Phase 2 stage of development. The second pipeline drug class from this Program consists of gallium-containing compounds, including Ganite, the company's first approved drug, followed by novel oral formulation of the active ingredient in Ganite, that are intended to treat diseases associated with accelerated bone loss. |
|
|
| Status |
| G Ganite Cancer-related hypercalcemia Anti-resorptive bone agent Marketed
T Tesetaxel Gastric, bladder, prostate and breast cancers, and melanoma Oral tubulin-binding taxane; overcomes multidrug resistance Phase 2; Phase 3 pending
Oral Gallium Prevention of bone complications in bone metastases, Paget?s disease, and osteoporosis Anti-resorptive and anabolic small molecule Phase 1 |
|
|
|
|
|
|
|
Biotech & Specialty Pharma
Healthcare Services
Medical Devices & Tech
OneMedPlace Member
AdvaMed Members
