NeoTherapeutics erhält US-Patent - 500 Beiträge pro Seite | Diskussion im Forum

[Nachrichten [wO]]

Die Biotech-Firma NeoTherapeutics Inc. (NEOT) konnte im heutigen Handel bereits ein Hoch von 15$ vorweisen, ehe Gewinnmitnahmen den Kurs etwas nach unten revidierten, so dass die Titel derzeit an der NASDAQ mit 5/8$ oder 4,81 Prozent im Plus notieren zu einem Kurs von 13 5/8$.

NeoTherapeutics hatte heute bekanntgegeben, dass ihr ein US-Patent für eine Methode zum Regenerieren von Nervenzellen zuerkannt wurde. Diese Methode könnte beim Behandeln von neuro-degenerativen Krankheiten, wie z.B. Alzheimer, zum Einsatz kommen.

[Donkosak]

Alzheimer? Was ist das?Rollt die Lawine?

Die Alzheimer-Krankheit ist eine durch fehlerhafte Stoffwechselvorgänge hervorgerufener,langsam fortschreitender Verlust von Nervenzellen.Die Folge hiervon ist die Schrumpfung des Gehirns um bis zu 20 Prozent

Nach umpfangreichen Studien leiden derzeit zwischen 6,5 und 8,7 Prozent der über 65-Jährigen in Deutschland an einer Demenz.Dies entspricht einer Gesamtzahl von 830.000 bis 1,1 Millionen dement Erkrankter.

Zwar nicht neu stelle ich aber mit rein

NeoTherapeutics Completes Enrollment in Pivotal Trial in Alzheimer`s Disease for Neotrofin(TM)
WEDNESDAY, SEPTEMBER 05, 2001 9:15 AM
- PRNewswire

IRVINE, Calif., Sep 5, 2001 /PRNewswire via COMTEX/ -- NeoTherapeutics, Inc. (Nasdaq:NEOT announced today that 521 patients at 51 clinical sites around the United States have been enrolled in the Company`s double-blind, placebo-controlled pivotal study of Neotrofin(TM) in Alzheimer`s disease. All 521 patients are currently receiving Neotrofin or placebo, and all patients are expected to complete the first twelve weeks of this study by this November. Data will then be processed and analyzed, and results should be reported during the first quarter of 2002. Enrollment and randomization of patients was completed in approximately four months -- about two months ahead of projections.

"The rapid pace of enrollment in this trial reflects the excitement among Alzheimer`s clinicians, patients and caregivers about Neotrofin and the hard work of our in-house clinical management team," said F. Jacob Huff, M.D, Vice President, Medical Affairs of NeoTherapeutics. "We are grateful to the 51 clinics and their staffs, who participated enthusiastically in this trial, and enabled us to surpass our enrollment time-line objective by one-third. We also appreciate the interest and effort of the more than 700 Alzheimer`s patients, and their caregivers, who went through the screening process. It is our greatest hope that the results of this trial will be a major step toward providing relief to those who suffer from this terrible disease."

"I am proud of the job that our clinical team has done on the design and enrollment of this pivotal Alzheimer`s trial," stated Rajesh C. Shrotriya, M.D., President and Chief Operating Officer of NeoTherapeutics. "A great deal of planning and input from some of the world`s leaders in Alzheimer`s disease went into the design of this trial. Excitement about our drug and hard work by our clinical team, as well as participating clinicians, led to the enrollment and randomization of over 500 patients in just four months.

"We believe that all of this will be accomplished for millions of dollars less than could have been done had the study been managed by a clinical research organization," added Dr. Shrotriya. "This is secondary, though, to the hope that Neotrofin provides patients both as a potential symptomatic treatment and a potential disease-course modifying agent. To that end, we remain focused on getting the New Drug Application (NDA) filed for symptomatic treatment in the shortest time frame possible, and the rapid enrollment is most important in that regard."

This clinical study, designed to be "pivotal" for registration, will evaluate the effectiveness of higher doses in treating symptoms of Alzheimer`s disease. The study incorporates 12 weeks of treatment for the primary analysis, followed by 12 weeks of treatment in order to allow patients initially given placebo to receive Neotrofin. During the first 12 weeks, the protocol for this study calls for patients to receive 500 mg of Neotrofin or placebo twice per day for one week, and then to receive 1,000 mg of Neotrofin or placebo twice per day for eleven weeks, assuming no adverse reactions during the first week of dosing. To date, there have been no unexpected or serious adverse reactions. Nearly all patients who have completed the first week have been escalated to the higher dose, with good tolerability reported.

The primary endpoints for this study are the Alzheimer`s Disease Assessment Scale-cognitive subscale (ADAS-cog), which measures memory and other cognitive deficits, and the Alzheimer`s Disease Cooperative Study- Clinicians Global Impression of Change (ADCS-CGIC). There are four secondary endpoints consisting of standard memory and behavioral tests that are also being administered during the study. Entry criteria for the study includes an ADAS-cog score greater than 18 and a Mini-mental Status Exam (MMSE) score of between 10 and 24. These entry criteria are stricter than those used in the Company`s previous Alzheimer`s disease clinical studies, and ensure that patients meet the "mild-to-moderate" category for which it is believed that Neotrofin can show maximum benefit.

A second and longer-term pivotal study is planned to commence in 2002, in which disease course modification will be measured over one year of treatment, while effects on symptom improvement will be measured after 12 weeks of treatment. Assuming positive data from both the current and the second 12-week studies, the Company expects to file an NDA with the U.S. Food and Drug Administration (FDA) in 2003.

In previous human clinical studies, Neotrofin has been shown to improve memory and behavior in patients with "mild-to-moderate" Alzheimer`s disease. Most recently, in a phase 2 clinical study conducted by Steven Potkin, M.D., professor of psychiatry and director of the Brain Imaging Center at the University of California, Irvine, patients treated with 500 and 1,000 mg doses of Neotrofin experienced statistically significant improvement in memory, attention and judgement. These behavioral improvements at the higher doses were consistent with changes in brain metabolism seen using Positron Emission Tomography scanning and changes in brain waves measured by electroencephalography.

NeoTherapeutics seeks to create value for stockholders through the development of central nervous system drugs by its neurology division, in-licensing and development of anti-cancer drugs through its NeoOncoRx subsidiary, and the licensing out of new drug targets through its NeoGene Technologies subsidiary. The Company`s most advanced drug, Neotrofin(TM), is currently being developed for Alzheimer`s disease and other neurodegenerative diseases, such as Parkinson`s disease and spinal cord injury. For additional information visit the Company`s web site at www.neotherapeutics.com.

Bis dann Euer Donkosak-Grischka

[Donkosak]

Hallo

Noch ein kleiner Nachtrag.In den USA leiden aktuell 4 Millionen Menschen an der Alzheimer-Krankheit.Im Jahre 2050 sollen es 14 und weltweit im Jahre 2025 22 Millionen Erkrankte sein.

Donkosak

[Donkosak]

Hier nochmal warum die Aktie so interessant!


IRVINE, Calif., July 26 /PRNewswire/ -- NeoTherapeutics Inc. (Nasdaq: NEOT; NEOTW) announced today that Dr. Alvin J. Glasky, CEO and Chief Scientific Officer, presented data on its lead compound, Neotrofin(TM), at the "4th International Neurodegeneration in Alzheimer`s Disease, Parkinson`s Disease and Related Disorders" meeting in Princeton, N.J. Dr. Glasky showed data from experiments demonstrating a statistically significant increase of 32 percent in brain stem cells in the hippocampus of mice, an area of the brain associated with memory. In experiments conducted at NeoTherapeutics, the company has demonstrated that brain stem cells can mature into neurons and astrocytes. Studies are underway to assess the effect of Neotrofin on this differentiation process.

Neotrofin is a purine derivative that induces, in the nervous system, the production of certain proteins, called neurotrophic growth factors, that are involved with survival and differentiation of neurons. Neotrofin is currently in pivotal clinical studies as a therapy for Alzheimer`s disease and in Phase 2 testing for Parkinson`s disease and spinal cord injury.

"I think this data is provocative and very exciting," said Dr. Zaven Khachaturian, former Associate Director of the Office of Alzheimer`s Research at the National Institutes of Health. "I certainly would want to learn more and see this kind of research continue, because it is my gut feeling that this is the kind of approach that is going to lead to the most viable treatments...much more effective than the options we have now."

"Stem cell research is the cutting edge of new attempts to replace aging or diseased nerve cells," said CEO Dr. Alvin Glasky. "Neotrofin appears to be a regenerative drug in the truest sense of the word in that it may enhance the brain`s limited ability to repair itself by stimulating the production of new cells in the brain. Our greatest hope is that these new stem cells might one day prove to slow down or reverse a variety of neurodegenerative brain disorders, such as Alzheimer`s disease and Parkinson`s disease," added Dr. Glasky. "Neotrofin may be the first practical approach to unleash the therapeutic potential of brain stem cells. In addition, Neotrofin may reduce the need to use embryonic tissue as a source of brain stem cells for surgical implantation in neurodegenerative diseases."

Brain stem cells are immature cells that retain the potential to multiply and develop into new nerve cells. This process is called neurogenesis. Once cells mature to become neurons they can no longer divide, and upon loss due to disease or injury, they must be replaced for the brain to retain function. The dogma had been that neurogenesis only occurs in young animals and humans and, that once an organism reaches adulthood, this process no longer occurs. This gave rise to the assumption that once nerve cells were lost there was no way to repopulate an injured or diseased brain. Loss of neurons is the basis for many diseases, including Alzheimer`s disease, Parkinson`s disease, Huntington`s disease, and for the deficits seen as a result of spinal cord injury, traumatic brain injury and stroke.

NeoTherapeutics seeks to create value for shareholders through the development of central nervous system drugs by its neurology division, in- licensing and development of anti-cancer drugs through its NeoOncoRx subsidiary, and the licensing out of new drug targets through its NeoGene Technologies subsidiary. The Company`s most advanced drug, Neotrofin(TM), is currently being developed for Alzheimer`s disease and other neurodegenerative diseases, such as Parkinson`s disease and spinal cord injury. For additional information visit the Company`s web site at www.neotherapeutics.com.

Euer Donkosak-Grischka

[Donkosak]

Dachte wirklich nicht das ich der einzige bin der die Aktie beachtet (nur ein weinig wer doch schon super)

Nicht so wichtig stelle es aber trotzdem mit rein

Spinal Cord Injury
NeoTherapeutics Expands Neotrofin Trials To Additional Sites




2001 SEP 22 - (NewsRx.com) -- NeoTherapeutics, Inc. (NEOT) announced that it has expanded its Neotrofin spinal cord injury trial to include Thomas Jefferson University Hospital, Pennsylvania, and Craig Rehabilitation Center, Denver, Colorado.

Seven patients are currently receiving Neotrofin: five at Rancho Los Amigos Hospital in Los Angeles, California, and one each at Craig Rehabilitation Hospital and Thomas Jefferson University Hospital. The four currently active centers are expected to enroll a total of 30 to 40 patients for 12 weeks of dosing.

Craig Hospital in Denver, Colorado, has long been recognized as a premier national Center of Excellence in the specialty of rehabilitation and research for patients with spinal cord injury and acquired brain injury. Craig Hospital has treated more than 23,000 patients since 1956 - more than any other single facility in the world. The principal investigator at this site is Daniel Lammertse, MD.

Thomas Jefferson University Hospital, in affiliation with the Magee Rehabilitation Hospital, is designated as one of the nation`s 18 regional Research Spinal Cord Injury Centers and a Center of Excellence in the treatment of spinal cord injury. Located just outside Philadelphia, Pennsylvania, the center has treated more than 2,500 patients. The principal investigator at this site is Anthony Burns, MD.

"We are pleased to have four of the leading centers for spinal cord injury participating in this clinical study," said F. Jacob Huff, MD, NeoTherapeutics. "Craig Rehabilitation Hospital, Rancho Los Amigos, and Thomas Jefferson University are three of the eighteen regional Centers of Excellence for treatment of spinal cord injury in the United States, and Gaylord Hospital in Wallingford, Connecticut, has a long tradition of providing high quality patient rehabilitation."

"The expansion of our Neotrofin clinical trials into spinal cord injury and Parkinson`s disease reflects the broad range of activity the drug has demonstrated in pre-clinical neuro-degenerative models," stated Rajesh C. Shrotriya, MD, NeoTherapeutics. "We have compelling pre-clinical data showing neuro-protection and nerve regeneration potential in the brain, the spine and the peripheral nervous system. Our clinical trial program for Neotrofin continues to expand to reflect the growing number of potential applications for our lead drug."

In this 12-week, open-label study, patients with subacute, complete spinal cord injury will receive Neotrofin for 12 weeks, and will be evaluated at regular intervals. In addition to extensive assessments for tolerance and safety, the Standard Neurological Classification of Spinal Cord Injury (SNCSCI) - manual motor exam score will be used as the primary evidence of preliminary efficacy. Secondary efficacy measures include the American Spinal Injury Association (ASIA) impairment scale (ASIA-IS), Functional Independence Measure (FIM) and SNCSCI-sensory exam.

The Christopher Reeve Paralysis Foundation says that there are approximately 250,000 spinal cord injured individuals (SCI) living in the United States. Sixty percent are first affected between 16 and 30 years of age, and 90% of SCI individuals survive and have near normal life spans. There are approximately 10,000 new spinal cord injury cases per year. Initial hospitalization lasts 100 days, on average, and lifetime costs for individuals with SCI average $600,000. Current clinical practice recommends the early use of high doses of methylprednisolone for 24 to 48 hours after injury, but the effects of this treatment are limited, and there are no specific FDA-approved treatments for spinal cord injury.

This article was prepared by Pain & Central Nervous System Week editors from staff and other reports. Copyright 2001

Bis dann Donkosak