Today we were
informed that the 100th patient was randomized in the trial. This is
wonderful news, the patient selection goes faster than projected, this is
quite rare phenomena in clinical trials world. If the clinics maintain their
enthusiasm and pace we will have phase II/b results by the fall says Zan
Fleming, the Chief Medical Officer of N-Gene and the leader of our clinical
effort.
First patient's treatment
finished (February 10, 2011)
- read more>>
Today the first
patient completed its 13 weeks treatment period in the trial and had his/her
last visit. We don not know if the patient received placebo or BGP-15, we
will only know it, once the 300 patients are finished, which again we expect
by this fall.
German approval granted (January
26, 2011)
- read more>>
Once the FDA consent was granted and the
US leg of the clinical trial started, we also applied in Europe to receive
approval in Germany and in Hungary to conduct the same, multi center
clinical trial, which we pursue in the US. We are happy to report that today
the German authorities gave their final consent to commence the trial in
Germany. This again is a meaningful milestone and will accelerate the
patient enrollment into the trial. In Germany 5 clinics are involved with
the clinical program. In about 10 days time all the clinics will be equipped
with the clinical samples and the treatment will commence in Germany. We
expect that the Hungarian approval will also be granted shortly, which would
mean that additional 5 Hungarian clinics will commence the trial's program.
First patient randomized
(November 11, 2010)
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Today the first patient was enrolled into
our phase II/b human clinical trial. This is huge step for us, a really big
milestone. Today, in the US the first patient started taking BGP-15 (or
placebo). Since there are 20 US clinics who are involved in the trial, we
expect that these numbers will grow quick and will have a decent flow of
patient enrollment.
First patient screened (October
29, 2010)
- read more>>
Today, after being cleared by the FDA to
commence our phase II/b clinical trial the first patient was screened to be
eligible to enter the current phase II/b clinical trial. According to the
protocol of the trial diabetic patients, which are currently treated with
anti diabetic medication (Metformin or metformin + sulfonylureas) and
despite their medication have poor glucose utilization properties, if their
blood glucose level is sufficiently high to meet inclusion criteria into the
trial. The screening takes two weeks and patients meet their doctor 3 times
during the two week period. Once they meet all the inclusion criteria and
are ready to take on to be part of the clinical trial, sign an "Informed
Consent Form". We expect that a sizable portion of the screened population
will eventually enter the trial and will be treated with our drug or
placebo. The screening commenced only in the United States, while Germany
and Hungary will follow later.
On
April 1, 2008, N-Gene applied for permission to the FDA for conducting a 13
week multiple dose, placebo controlled dose finding study to test the effect
of BGP-15 on HbA1C in addition to metformin therapy in 300 diabetic patients
in the USA, Germany and Hungary. The clinical study protocol is entitled "A
Randomized, Double-blind, Placebo-controlled, Parallel Group, Multiple Dose,
Multicenter Study to Assess the Safety and Efficacy of BGP-15 when
Administered Orally Once or Twice Daily as Add-on Therapy to the Combination
of Metformin and Sulfonylurea Treatment or Metformin Alone in Patients with
Type 2 Diabetes Mellitus (BGP-15-CLIN-IR04)". The trial has been permitted
by the FDA, application to the German and Hungarian Drug Agencies is
currently underway. The first subject was randomized to treatment in the
study on November 12, 2010, final report is expected around 4Q, 2011.
The study is currently running in 20 US clinics geographically spread all
over the United States. It is the expectation of the Company that appr 200
patients will be randomized in the United States, while the remaining 100
patients will be randomized in Germany and in Hungary in each country in 5-5
clinics. Due to the fact that US authorization to conduct the study is
already available, while both the German and the Hungarian applications are
in the evaluation phase, and because the study enrollment is competitive it
is possible that the US sites will enroll more patients and the European
sites will enroll less patients.
Initial estimate projected that the last patient will be enrolled in April
2011, this seems to be far too ambitious, due to the delay in the European
leg of the clinical trial. The speed of patient enrollment will eventually
decide when will the last patient enrolled in the trial, we hope that it
will be mid 2011.
Successful Investigator Training Meeting (September 15, 2010)
- read more>>
N-Gene Inc. conducted an Investigator Training Meeting on
September 13, 2010 in
Scottsdale, Arizona, US to prepare US study site principal
investigators for the Phase 2B clinical trial of BGP-15
aimed at testing the safety and efficacy of BGP-15 in
patients with Type 2 diabetes mellitus. Participants
received information about the clinical program, the
protocol, the study medication, study timelines & enrollment
expectations, investigator obligations, safety/SAE
reporting, data management/CRF completion and query process,
laboratory procedures, and study supplies and forms. The
meeting was very successful.
Mark Febbraio assumes joint CSO position (April 26, 2010)
- read more>>
On April 26, 2010 Prof Mark Febbraio accepted the invitation
to become joint Chief Scientific Officer of N-Gene Inc. We
are happy and proud that Mark accepted our invitation. He
brings an enormous amount of experience in the heat shock
protein research. Mark has been working with N-Gene for some
years now. Together with his colleagues he published a
landmark article in PNAS about the mechanism of action of
BGP-15, which created due interest in the science
community.. Mark is happy to join N-Gene and share
responsibilities for scientific research with dr. Peter
Literati, co-CSO of the company. With Mark's involvement
N-Gene's research activity will become more systematic,
transparent, well published and represented at venues where
it needs to be represented.
Mecsek Pharma Ltd. (March 20,
2009) - read more>>
In
2009, N-Gene Inc., together with Pécs University , established a special
purpose company named MECSEK PHARMA Research, Development and Service Ltd.
for utilizing the unique grant possibilities available to the company. . In
the same year, Mecsek Pharma was awarded a HUF 1 Billion Ft non refundable
grant ( appr. USD 5 million matching grant) in the context of The Economic
Development Operational Programme (EDOP) of Hungary. The grant program is
partially financed by the EU. This non refundable grant is a matching grant,
i.e. equal amount of self financing is required to be able to utilize the
grant. Approximately two thirds of the grant finances N-Gene's Phase II/B
clinical trial while other projects such as research and educational
projects are financed by the remaining one third of the grant. Mecsek Pharma
is proceeding well in advancing the clinical trial.
On January 9 2009 , N-Gene Inc. closed a $5M investment deal
with Bankar Holding Zrt of Hungary. Bankar is investing the
$5M in three installments, of which the first, in the amount
of $2.5M was closed on January 9, 2010.
Mr. Gabor Kovacs, the owner of Bankar Holding Zrt has been
appointed to be a member of the Board of Directors of N-Gene
Inc. This investment, together with the $5M EU/Hungarian
grant award, allows N-Gene to complete the phase II
development program of BGP-15. We are all thrilled and happy
for Bankar's investment and Gabor Kovacs's personal
involvement in the business of N-Gene, which we all believe
will bring it to fruition for all of our shareholders.
