da es aktuell wieder etwas ruhiger hier im Forum geworden ist, poste ich mal eine update von Telix :)
VG
http://telixpharma.com/wp-content/uploads/...rt_June_2020_quarter.pdfProstate Cancer Imaging and Therapy Program
Telix’s prostate cancer program comprises the prostate cancer imaging product TLX591-CDx
(68Ga-PSMA-11) and the prostate cancer therapeutic product TLX591 (177Lu-DOTArosopatamab).
Both the imaging and therapeutic products target prostate specific membrane
antigen (PSMA), an important and well-validated drug target in prostate cancer.
The TLX591-CDx program is the Company’s most advanced program, with the product
currently used under investigational (IND), clinical trial and special access use in the United
States and Europe.4 In April, Telix submitted a marketing authorisation application (MAA) in
Europe for TLX591-CDx. The submission was made to the Danish Medicines Agency (DKMA)
1 ASX disclosure 22/04/20.
2 ASX disclosure 21/07/20.
3 Dr Andreas Kluge is a Non-Executive Director of Telix Pharmaceuticals Limited and General Manager of ABX-CRO advanced
pharmaceutical services Forschungsgesellschaft.
4 TLX591-CDx is an investigational product and has not received marketing authorisation in any jurisdiction.
Page 2
in its capacity as a reference Competent Authority of a European member state. The DKMA
will coordinate and lead the evaluation of Telix’s MAA for TLX591-CDx on behalf of Denmark
as well as a basket of 13 additional European member states that have been nominated by
Telix.
Consistent with the current European Association of Urology (EAU) guidelines on prostate
cancer imaging, Telix has applied for a MAA in Europe for TLX591-CDx for the clinical
indication of imaging patients with elevated prostate-specific antigen (PSA) after radical
prostatectomy or radiation therapy. This indication, which is broadly termed “biochemical
recurrence” (BCR), is reported to occur in 20-40% and 30-50% of men who have undergone
prostatectomy or radiation therapy with curative intent, respectively.
In June, Telix provided an update on the progress of its New Drug Application (NDA) for
TLX591-CDx to the US Food and Drug Administration (FDA).5 The Company indicated that
new data reporting the superiority of 68Ga-PSMA-11 prostate cancer imaging compared to
conventional imaging in men with newly diagnosed high-risk prostate cancer had recently been
published and that as a consequence, the Company was considering a broader dataset in its
NDA submission. At this time, most modules of the NDA submission have been completed
and the Company is currently preparing for filing (completion during Q3).
Renal Cancer Imaging and Therapy Program
Telix’s renal (kidney) cancer program comprises the kidney cancer imaging product TLX250-
CDx (89Zr-girentuximab) and the kidney cancer therapeutic product TLX250 (177Lugirentuximab).
These products target carbonic anhydrase IX (CA9), which is highly expressed
by clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney
cancer. Telix expects TLX250-CDx to be the first diagnostic imaging agent to enable the noninvasive
assessment of patients with suspected ccRCC.
Telix’s ZIRCON trial is an international, multi-centre Phase III trial that compares pre-surgical
imaging using TLX250-CDx in detecting ccRCC, with tissue histology in patients undergoing
surgical resection. The ZIRCON trial is being conducted at 33 sites globally and will enrol
approximately 250 patients. During the quarter, the Company successfully applied for FDA
Breakthrough Designation (granted subsequent to the quarter6), an important accomplishment
for the Company as it will potentially accelerate the FDA product review and approval process
upon completion of the ZIRCON study.
While ZIRCON trial activity was paused during the period March to May due to the impact of
COVID-19, the Company indicated in June7 that the ZIRCON trial had recommenced patient
recruitment in Europe, approximately 2-3 months ahead of expectation. Further sites in
Australia, Canada, Turkey and USA are in the process of restarting clinical trial operations and
are expected to resume patient enrolment during Q3.