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Biotech / Medical : Neotherapuetics possibly has a breakthrough drug - NEOT -- Ignore unavailable to you. Want to Upgrade?


To: Icebrg who wrote (202)8/11/2003 6:34:23 PM
From: Nikole Wollerstein  Respond to of 204
 
I should admit it is very hard to evaluate fair market prce of SPPI at this point.

IRVINE, CA--(MARKET WIRE)--Aug 11, 2003 -- Spectrum Pharmaceuticals, Inc. (NasdaqSC:SPPI - News) announced that the U.S. Patent Office has published U.S. Patent Application No. 10/209,451 entitled "Tetrahydroindolone and Purine Derivatives Linked to Arylpiperazines" as Publication No. US-2003-0114463-A1. Provisional patent rights begin to accrue with the publication of a patent. This patent application covers the composition of matter and methods of use for a series of drug candidates which have shown positive effects in treating animal models of schizophrenia, while minimizing the negative side effects commonly associated with currently marketed anti-psychotic drugs. The Company is seeking partners to develop this new series of compounds, which may have applications in a variety of psychiatric and neurological conditions.

ADVERTISEMENT"The publication of this patent strengthens the legal protection of a very interesting technology platform, for which we are actively seeking a development partner. The anti-psychotic platform covered under this patent contains both typical and atypical candidates, supported by intriguing pre-clinical data," stated Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals. "We continue to actively discuss the licensing of this technology with potential partners who have the expertise and resources necessary to carry out proper and expeditious development."

In pre-clinical studies, these compounds have reversed the effects of the drug PCP on pre-pulse inhibition, a predictive animal model for human schizophrenia. In addition, while many of the currently marketed anti-psychotic treatments cause memory impairment, several of Spectrum's anti-psychotic compounds did not impair memory in animal models. Further, the compounds target unique receptor groups that may provide better efficacy and fewer side effects than other antipsychotic drugs.



To: Icebrg who wrote (202)9/22/2003 4:52:01 AM
From: Icebrg  Respond to of 204
 
GPC Biotech Receives Fast Track Designation for Anticancer Drug Candidate Satraplatin from U.S. FDA
Monday September 22, 1:45 am ET
MARTINSRIED/MUNICH, Germany and U.S. Research Facilities in

WALTHAM/BOSTON, Mass. and PRINCETON, N.J., Sept. 22 /PRNewswire-FirstCall/ --
GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX 30) today announced that
the U.S. Food and Drug Administration (FDA) has granted "fast track"
designation to satraplatin as a second-line chemotherapy treatment for
patients with hormone-refractory prostate cancer (HRPC).

The FDA's fast track programs are intended to facilitate the development and expedite the review of drugs to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The "fast track" designation enables a company to do a rolling submission, submitting sections of the NDA (New Drug Application) as they become available.

A multicenter, global, randomized study evaluating satraplatin plus prednisone versus prednisone alone as a second-line chemotherapy regimen for treating patients with HRPC is expected to begin soon. The primary endpoint of the trial will be the time to disease progression. The study's objectives also will include the evaluation of pain control and survival, as well as an assessment of drug safety in this patient population.

"The receipt of fast track designation from the FDA represents another important step forward in our strategy to advance satraplatin through the clinical/regulatory process as rapidly as possible," said Marcel Rozencweig, M.D., Senior Vice President, Drug Development of GPC Biotech. "This fast track designation recognizes the need for new, efficacious therapies in treating hormone-refractory prostate cancer patients who have failed one chemotherapeutic regimen. We will continue to work closely with the FDA throughout the trial process."