EIERSTOKKANKER.

Informatie over actuele ontwikkelingen in zowel reguliere als alternatieve en/of aanvullende behandelingen en middelen bij eierstokkanker in alle stadia. We hebben zo goed als mogelijk alle informatie op alfabetische volgorde gezet, zie linkerkolom, zodat u nog gemakkelijker en sneller bij de informatie kunt komen. 

 

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Immuuntherapie bij eierstokkanker: Ovarex bewijst waarde in verschillende trials met patienten met eierstokkanker.

Maart 2004: Bron: Altarex

Altarex , de producent van o.a. ovarex meldt vandaag aan de beurs in Amerika dat verschillende trials (Phase I en II) significante resultaten laat zien bij patiënten met eierstokkanker, met name in de tijdsduur van een recidief na een eerdere chemobehandeling. Lees onderstaand persbericht met in uw achterhoofd dat het wel de producent is die deze resultaten naar buiten brengt. Maar een percentage van 41% minder risico op een recidief is behoorlijk spectaculair, zeker als je bedenkt dat deze trial is gedaan bij maar liefst 345 vrouwen. 

AltaRex Presents Expanded OvaRex(R) Clinical Results at SGO - Clinical
Benefit Consistently Demonstrated in Well-Defined Population -
WALTHAM, Mass., March 15 /PRNewswire-FirstCall/ -- AltaRex Corp. (AXO.TO,
ALXFF.OTC) announced today the release of expanded clinical efficacy data from
its two completed placebo-controlled OvaRex(R) (oregovomab) trials for the
treatment of advanced ovarian cancer, as well as early immunological results
from its third well-controlled study.
Jonathan Berek, M.D., Chief of the Division of Gynecologic Oncology at UCLA
School of Medicine and co-principal investigator of the Company's lead OvaRex(R)
trial, will be presenting the OvaRex(R) development program and trial results at
the annual meeting of the Society of Gynecologic Oncologists (SGO), being held
March 16-20 in Miami. In a post-graduate course being held at the SGO meeting,
Dr. Berek is using OvaRex(R) MAb as the primary example of the promise that
immunotherapy holds for the future treatment of gynecologic malignancies. Also
at the SGO meeting, Alan Gordon, M.D., Director of Research and Gynecologic
Oncology for U.S. Oncology in Dallas, will be presenting primary results of a
20-patient "chemo-immunotherapy" study of OvaRex(R), for which he is the
principal investigator. The results will be the subject of a separate press
release and will be introduced by Dr. Gordon during SGO poster sessions March
17-18.
With regard to the Company's lead 345-patient OvaRex(R) trial, a statistical
model (Cox Proportional Hazard Ratio) for the well-defined population
demonstrates a 41% reduced risk of relapse for OvaRex(R)-treated patients as
compared with placebo, a result that is statistically significant (p=0.0313). A
decreased risk of relapse of greater than 25% is generally considered clinically
significant by practicing physicians. As previously reported, several prognostic
factors, including CA125 at initiation of study treatment, identify a
well-defined population that benefits significantly from treatment with
OvaRex(R) MAb.
Also being presented today is a 12-month progression free survival analysis of
the well-defined population. 62% of OvaRex(R)-treated patients with detectable
levels of CA125 at first dose remained progression versus 41% of patients on
placebo (p=0.0449). 65% of OvaRex(R)-treated patients with high normal baseline
CA125 of >9.5 U/mL at first dose remained progression free versus 18% of
patients on placebo (p=0.0012). These findings are particularly important,
given that patients with high normal baseline CA125 are considered to be at
higher risk for early disease relapse.
In light of these findings, the Company undertook new analyses of time to
disease relapse and progression free survival from its 55-patient controlled
trial. Unlike patients in the lead trial, those involved in this study were in
"biochemical relapse" on entry into the study, as defined by elevated CA125
levels but no measurable tumor. Therefore, 6-month rather than 12-month
progression free survival is a significant landmark in this more advanced
disease population. As reported today, in a similar well-defined population
representing about 42% of patients, the OvaRex(R) group experienced a 60%
increase in time to disease relapse versus placebo (10.8 months for OvaRex(R)
versus 6.9 months for placebo), and 6-month progression free survival of 75%
versus 36% (OvaRex(R) versus placebo). While these outcomes are not
statistically significant (largely due to smaller trial size), they demonstrate
consistency and will provide a positive contribution to the integrated analysis
that will form the basis of the Company's planned OvaRex(R) Biologics License
Application (BLA) for U.S. Food and Drug Administration approval of OvaRex(R)
MAb.
Importantly, for purposes of registration and clinical practice, all OvaRex(R)
studies to date demonstrate a benign safety profile. The placebo- controlled
trials also show that OvaRex(R) impact on quality of life is no different than
placebo.
Initial data from a third well-controlled study is also being presented by Dr.
Berek today. All 102 patients in this ongoing dosing study receive OvaRex(R) on
one of three different schedules. This phase II trial was designed to determine
ideal dosing frequency. Results indicate that more frequent dosing can speed up
induction of immune responses, but that similar responses are induced with the
same number of injections, independent of dosing schedule. Of the 102 patients
enrolled in this study, the Company has determined that 30 meet the well-defined
population criteria from the lead study. Therefore, the Company is considering
an amendment to the dosing frequency trial that would enroll an additional 90
patients who also meet the well-defined criteria. This would give the Company
trial results from an additional 120 active patients in the well-defined
population, providing an interim efficacy analysis in a timeframe in which the
OvaRex(R) BLA would be under review.
For more information about the Company, please visit the AltaRex website at
www.altarex.com.