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To: Al Collard who wrote (5900)1/10/2002 5:58:37 PM
From: J.E.Currie  Respond to of 11802
 
Thanks Al,
Still think Old man Murphy is lurking. If the street did know then this would be much higher.

This might help.

Genta Submits Investigational New Drug Application For Gallium Nitrate in Non-Hodgkin's Lymphoma

siliconinvestor.com

CEO Reviews Strategy for Product Franchise at Chase H&Q Conference
BERKELEY HEIGHTS, N.J., Jan. 10 /PRNewswire-FirstCall/-- Genta Incorporated (Nasdaq: GNTA chart, msgs) announced today that it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) for the study of gallium nitrate in patients with non-Hodgkin's lymphoma. Genta's Chief Executive Officer, Dr. Raymond P. Warrell, Jr., also reviewed clinical, regulatory, and marketing strategies for the Company's Gallium Products Franchise today at the Chase H&Q Investor Conference in San Francisco, CA.
Clinical Information
Gallium nitrate is an intravenous drug from the Company's Gallium Products Franchise. The Company acquired certain rights to patents and technology in this area, including ownership of an approved New Drug Application (NDA). The U.S. National Cancer Institute originally sponsored clinical studies that tested gallium nitrate as a cancer chemotherapy drug in patients with advanced cancer. Several of these trials suggested that the drug produced greater than 40% response rate in patients with refractory non-Hodgkin's lymphoma (NHL). Upon FDA acceptance of the new IND, Genta plans to initiate a multi-center trial in patients with low- or intermediate-grade NHL who have low blood counts, and who have failed chemotherapy and rituximab (Rituxan(R)). The Company believes that these patients do not currently have satisfactory treatment alternatives and, as such, that the indication represents an unmet medical need. Assuming that results of the new clinical trial confirm previously published reports, the Company will seek guidance from FDA regarding an acceptable NDA development plan in NHL, and possibly other types of cancer.
Regulatory Status
Intravenous gallium nitrate (as Ganite(R)) has previously received FDA approval for treatment of cancer-related hypercalcemia, an acute-care indication in which rapid bone loss leads to life-threatening levels of blood calcium. In addition to filing the new IND, Genta intends to submit a supplement to the NDA that will update changes in chemistry and manufacturing. While the Company does not currently anticipate a requirement for regulatory review of prior safety and efficacy data, the pace and outcome of the FDA review process will determine the timing of the Ganite(R) market launch. Genta also intends to submit an application to FDA in order to designate gallium nitrate as an "Orphan Drug" in NHL.
Sales and Marketing Strategy
Assuming a successful regulatory outcome, the Company currently intends to market and sell Ganite(R) on an exclusive basis in North America. The product will be positioned as a second-line therapy for seriously ill, hospitalized patients with hypercalcemia. Accordingly, Genta will be recruiting a sales force that will primarily focus on tertiary care cancer centers in North America. In order to address a considerably larger market, especially patients who suffer from cancer that has spread into bone (i.e., bone metastases), the Company is developing an oral formulation of a gallium-containing compound. This new drug would enable the use of low doses taken over an extended period of time in order to reduce fractures and pain. Dr. David J. Straus, an Attending Physician on the Lymphoma Service at Memorial Sloan-Kettering Cancer Center, and Clinical Professor of Medicine at Cornell University Medical College, commented: "I am greatly looking forward to being able to re-study gallium nitrate in a new clinical trial. My extensive prior experience with the drug suggests that it may be an important and well-tolerated addition to the treatment of patients with advanced lymphoma."
"Genta has indicated that it intends to be a direct marketer of its products in North America," said Dr. Raymond P. Warrell, Jr., Chairman and CEO of Genta. "Depending upon the application and review process, we believe that Ganite(R) will be the first drug launched by the Company, ahead of our lead antisense compound, Genasense(TM). While we feel the hypercalcemia market is currently underserved by competitive products, we have an important opportunity to validate the prior studies in NHL. Assuming we reconfirm those results, we would like to submit a supplemental NDA to use slightly higher doses as a direct cytotoxic drug for patients with NHL."
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on anticancer therapy. The Company's research platform is anchored by oligonucleotide chemistry, particularly applications of antisense and decoy aptamer technology. Genasense(TM), the Company's lead compound, has received "Fast Track" and "Orphan Drug" designation from the Food and Drug Administration. Genasense(TM) is currently undergoing late-stage, Phase 3 clinical testing in several clinical indications. Genta's pipeline also comprises a portfolio of small molecules, including gallium-containing compounds for treatment of diseases associated with accelerated bone loss, and Androgenics compounds for prostate cancer. Genta aims to become a direct marketer of its pharmaceutical products in North America. For more information about Genta, please visit our website at: genta.com.



To: Al Collard who wrote (5900)1/11/2002 4:02:20 PM
From: Daytek77  Read Replies (2) | Respond to of 11802
 
Hi Al put me down for TNT-T for next week

Thanks



To: Al Collard who wrote (5900)1/11/2002 4:17:51 PM
From: vds4  Read Replies (2) | Respond to of 11802
 
ok, i think it is overbought like crazy, and that it will crash and burn back to the 50 ema... but what the heck. put me down for T-CUR al. maybe there is something behind the volume.



To: Al Collard who wrote (5900)1/11/2002 4:31:02 PM
From: KC Jones  Read Replies (1) | Respond to of 11802
 
Put me down for V.MOA for next week please.

KC



To: Al Collard who wrote (5900)1/11/2002 4:37:17 PM
From: marcos  Read Replies (2) | Respond to of 11802
 
cpt.v - 32,258 shares at .31 last ... next week for the Golden Capital wall, crossing my toes ... offer is raised on segb to 1.01, hard to say what that means

Looks like Stew took this week with that Firelight thing, if so good show Stew ... i meant to look at it but am way behind in homework ... cheers all