- Completed patient dosing in US Phase 3 clinical trials.
- There will be a two-year follow-up period, followed by
submission of the Biologics License Application (BLA) to permit
marketing of TG-C once approved.
ROCKVILLE, Md., July 11,
2024 /PRNewswire/ -- Kolon TissueGene, Inc. ('the
Company") announced today that patient dosing has been completed on
the US Phase 3 clinical trials for Knee Osteoarthritis. Since
resuming patient recruitment in November
2021, the Company has completed 2 large clinical trials
involving 1,066 patients in about 30 months.
Completion of patient dosing is a big milestone which enabled
the Company to complete the pivotal Phase 3 clinical trials. The
Company worked diligently with the US Food and Drug Administration
(FDA) to get the clinical hold lifted in April 2020, which allowed resumption of the Phase
3 clinical trials in the US. The clinical hold was successfully
lifted through extensive research based on scientific data on TG-C
and an intensive regulatory review process.
Even though there were difficulties in the Phase 3 clinical
trial process such as significant delays of the clinical studies in
the US due to the global pandemic, the Company was able to complete
patient dosing in the Phase 3 clinical trials with the
determination and conviction to succeed in developing the world's
first and only cell and gene therapy for osteoarthritis of the
knee.
During the patient recruitment process, approximately 6,700
patients signed up to participate in the Phase 3 clinical trials.
Among them, more than 1,000 patients met eligibility criteria and
were enrolled in the Phase 3 clinical trials.
In accordance with the protocol, the Company will continue a
two-year follow-up on all dosed patients to assess the safety and
efficacy after TG-C administration. The results of the Phase 3
clinical trials will be published at the end of the two-year
follow-up period.
During the follow-up period, the Company will prepare the BLA
submission package for the US FDA in order to obtain marketing
authorization of TG-C in the US. The Company has already begun
preparations related to commercial production (manufacturing) and
is collaborating with Lonza, the world's largest pharmaceutical
CDMO.
"We expect the Phase 3 clinical trials to provide positive
results, similar to the successfully completed Phase 2 clinical
trial in the US" said Moon Jong Noh,
PhD, CEO of the Company, adding, "When the Phase 3 clinical trials
are successfully completed, we will start discussions with
potential partners for commercial sales and marketing along with
completion and submission of the BLA for product approval." In
addition, he said, "All executives and employees will do their best
to repay all customers, shareholders, and others who have trusted
and waited for the Company for a long time with meaningful
results."
About Kolon TissueGene, Inc.
Kolon TissueGene, Inc., is an advanced cell therapies company that
has developed a first-in-class cell and gene therapy targeting OA
of the knee. The Company's lead product, TG-C, is an allogeneic
cell and gene therapy. The Company is conducting Phase 3 clinical
trials in the US under a Special Protocol Assessment (SPA)
agreement reached with the US FDA. Information about the trials can
be found at the National Institutes of Health registry,
www.clinicaltrials.gov. For additional information about
Kolon TissueGene, Inc., please visit www.tissuegene.com.
About TG-C
TG-C is a first-in-class cell and
gene therapy targeting OA of the knee through a single
intra-articular injection. Clinical trials held in the US and
abroad have demonstrated pain relief and increased mobility, as
well indicators towards decreased progression of OA and
improvements in joint structure. The allogeneic (off-the-shelf)
drug could provide an alternative to traditional treatment and
surgery, or delay the progression of OA to minimize the need for
multiple surgical interventions. In a concluded US Phase 2 clinical
trial, Kolon TissueGene demonstrated a two-year improvement of pain
and function. The Company seeks to continue to support these
results through its Phase 3 clinical trials. In addition, the
Company has designed the trials to seek a disease-modifying
osteoarthritis drug (DMOAD) designation for TG-C from the US
FDA—potentially making TG-C the first therapy to receive such a
DMOAD label.
View original
content:https://www.prnewswire.com/news-releases/kolon-tissuegene-completes-patient-dosing-in-two-pivotal-us-phase-iii-clinical-trials-for-tg-c-302195060.html
SOURCE Kolon TissueGene, Inc.