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07.07.2010 Wedel, Germany Oncoscience AG and GenIlac agree on cooperation terms
in Turkey
Oncoscience, Wedel and GenIlac, Ankara agree on cooperation in
Turkey for Nimotuzumab(Theraloc®), an EGFr antibody, which is being
developed by Oncoscience in Europe.Oncoscience grants GenIlac the
rights to apply for marketing approval for nimotuzumab in Turkey and for
marketing the antibody in the territory.
Oncoscience will take an active advisory role guiding GenIlac in the
conduct of clinical trials and aid in the compilation of regulatory
documentation for the approval process at the Turkish Ministry of
Health.
The cooperation will result in faster recruitment in already ongoing
studies. Additionally new indications will be explored.
„We are very happy to have found such an able partner in GenIlac who
has a leading role in Turkey based on the company’s product portfolio.
GenIlac is a privately owned company and the two companies’ firm
philosophies are nearly identical“ said Ferdinand Bach, CEO of
Oncoscience AG. „The data generated in this cooperation will suppelement
data for regulatory purposes and lead to faster market entry for
nimotuzumab(Theraloc®)“.
Abidin Gülmüs ,CEO of Gen Ilac added ‘‘Oncoscience and GenIlac
complement each other very well in their market and product views. We
are very much excited to serve the Oncology Society with unmet needs
with a non toxic EGFr antibody to the Turkish patients in the near
future.“
09.10.2009 Wedel, Germany Oncoscience AG presents results from Phase III study of Nimotuzumab (Theraloc®)
in patients with diffuse intrinsic pontine glioma at the 41. SIOP, Sao
Paulo, Brazil, October 6th-9th, 2009
On Friday October 9th, 2009 results from the Phase III study of the
monoclonal antibody
Nimotuzumab were presented.
At the world’ s
convention for pediatric
oncology in Sao Paulo data were presented that show that Nimotuzumab in
combination with
radiotherapy achieves comparable results in patients with diffuse
intrinsic pontine glioma as
combination of aggressive chemotherapy and radiotherapy.
The results do however differ significantly in the much lower
side-effect profile observed
with the Nimotuzumab treatment.
Children are able to stay at home, even attending school or kindergarten
while undergoing
antibody therapy.
Response to study treatment after 24 weeks was 75%. Median survival of
all patients was
recorded at 9,6 months, where responders had a median survival of 11,4
months.
After one year 34% of patients were still alive.
The results from this first-line therapy study are consistent with the
excellent response rate for recurrent patients (ASCO 2008) and serve to further confirm the
excellent tolerability of Nimotuzumab compared to aggressive chemotherapy, absence of side-effects
commonly associated for other monoclonal antibodies and diarrhoea or
exanthema caused by concomitant medications.
The results from this first-line therapy study are consistent with the
excellent response rate for recurrent patients (ASCO 2008) and serve to further confirm the
excellent tolerability of
Nimotuzumab compared to aggressive chemotherapy, as well as absence of
side-effects
commonly associated for other EGFR - monoclonal antibodies like
diarrhoea or drug related
exanthema.
04.10.2008 Wedel, Germany Funcrypta – Poster presentation at European Bioperspectives
Oncoscience AG is a member of the German Funcrypta project. Within the
scope of this cooperation a poster will be presented at European
Bioperspectives, Hannover, 7.-9. Oct. 2008. Preview the poster
here (.pdf)
Visit the project website:
http://www.funcrypta.de
European Bioperspectives:
http://www.bioperspectives.org/
22.04.2008 Wedel, Germany
Oncoscience AG receives EU orphan drug status for the EGFR monoclonal
antibody Nimotuzumab (Theraloc®) for the treatment of pancreatic cancer.
Oncoscience AG announced that their anti-cancer
drug Nimotuzumab (Theraloc®) has been designated an orphan drug by the
European Medicines Agency (EMEA) for the treatment of pancreatic cancer.
OSAG has licensed nimotuzumab for Europe and 20 other countries around
the European area and will market the drug under the name „Theraloc®“.
Currently a phase III trial with patients suffering from pancreatic
cancer is being conducted. The placebo, double blinded, controlled study
in patients with unresectable, metastatic pancreatic cancer compares
Gemcitabine + Placebo versus Gemcitabine + Nimotuzumab. At the moment
only patients from Germany are enrolled in the study; furthermore
patients will be recruited from other parts of the Oncoscience territory.
An additional phase III trial investigating a type of brain cancer,
diffuse intrinsic pontine glioma in paediatric patients, is ongoing.
Patient recruitment started in April 2006 and was concluded by August
2007. Results from this study are expected to be released during the
second half of 2008.
A third phase III trial is being conducted with adult glioma patients
suffering grade IV tumors. Patients are randomized and receive a
combination therapy of radiation+temozolomide +/- nimotuzumab. Out of
the 150 patients needed for the study, 30% have already been recruited.
Oncoscience AG already hold marketing approval in the Ukraine since
October 2007 and applied for marketing approval in Europe (EMEA),
Switzerland and Russia.
Wedel, October 26th, 2007
The European Medicines Agency, EMEA, concludes its formal
validation of the marketing authorization application for Theraloc® (Nimotuzumab)
positively
The application for marketing authorization of Theraloc® (Nimotuzumab)
was submitted to EMEA on October 4th, 2007.
After formal validation the application was accepted by the EMEA on
October 25th, 2007.
October 25th, 07 has also been set as “day 0” of the application
procedure. The list of questions from EMEA is expected in February 2008
(day 120)
The acceptance of the marketing authorization application of Theraloc®
-and thus the initiation of the authorization procedure- is the biggest
milestone in the six year history of the biotech company Oncoscience AG,
in Wedel, Germany.
Oncoscience AG, a biotechnology company based in Wedel, Germany is
currently conducting three phase III clinical trials with the monoclonal
EGFR- antibody, Nimotuzumab.
- Phase III study of 1st line treatment in children with diffuse
intrinsic pontine glioma in combination with radiotherapy
- Phase III study in adult patients with grade IV brain tumors
after surgery and adjuvant radiotherapy plus chemotherapy
- Phase III study of 1st line therapy in patients with inoperable
pancreatic cancer plus chemotherapy
Wedel, October 13th, 2007
Oncoscience AG reports marketing authorization approval for
Theraloc® (Nimotuzumab) in the Ukraine
On October 12th, 2007 Theraloc® was approved in the Ukraine by the
Ministry of Health of Ukraine.
As of now Theraloc® is approved for therapy of cancers of the head
and neck, grade III and IV brain tumors of adult patients, as well as
for therapy in children with recurrent anaplastic astrocytoma grade III,
glioblastoma grade IV, and with diffuse intrinsic pontine glioma.
The marketing authorization approval is an important step for
additional marketing authorization approvals in the Europe. The approval
also confirms that the direction of the development program is justified
and that data are sufficiently qualified.
Theraloc® will be made available to patients in the Ukraine as soon
as possible and the approval for the medication in Europe will be
actively pursued.
Oncoscience AG, a biotechnology company based in Wedel, Germany is
currently conducting three phase III clinical trials with the monoclonal
EGFR- antibody, Nimotuzumab.
- Phase III study of 1st line treatment in children with diffuse
intrinsic pontine glioma in combination with radiotherapy
- Phase III study in adult patients with grade IV brain tumors
after surgery and adjuvant radiotherapy plus chemotherapy
- Phase III study of 1st line therapy in patients with inoperable
pancreatic cancer plus chemotherapy
Wedel, September 12th 2007
ONCOSCIENCE AG ANNOUNCES COMPLETION OF PATIENT ENROLLMENT IN
PHASE III TRIAL OF NIMOTUZUMAB, IN FIRST LINE TREATMENT OF CHILDREN WITH
INOPERABLE BRAIN CANCER
Clearance Received for Two Additional Late-Stage Trials in Adult
Glioma and Pancreatic Cancer
Today Oncoscience AG (Wedel, Germany) announced, about the
development of the humanized EGFR-targeting monoclonal antibody,
nimotuzumab, has recruited the 40th and final patient in its trial
combining nimotuzumab with radiation for the treatment of children and
adolescents suffering from diffuse intrinsic pontine glioma (DIPG), an
inoperable form of cancer for which treatment options are severely
limited.
The Phase III trial was conducted by an international group of
paediatric oncologists under the lead of principal investigator
Professor Udo Bode from University of Bonn, Germany. The primary
end-point of the trial is progression-free survival; secondary endpoints
are survival, response rate and improvement of neurological symptoms.
Results are expected end of first half 2008.
In addition, Oncoscience has advised that two additional late-stage
trials have been cleared to commence in Europe:
- A randomized multi-centre study in which nimotuzumab and the
current standard of care (radiotherapy with concomitant and adjuvant
temozolamid) will be compared to the current standard of care in
patients with glioblastoma multiforme (GBM). The study is expected
to recruit 190 patients within 24 months. The primary end-point for
this trial is Progression-Free Survival, with Response Rate and
Symptom Control among the secondary endpoints.
Nimotuzumab has received Orphan Drug
designation from EMEA.
- A randomized multi-centre study in chemotherapy-naive patients
suffering from locally advanced or metastatic pancreatic cancer who
will be treated with either gemcitabine plus nimotuzumab or
gemcitabine plus placebo is expected to recruit 188 patients within
24 months. The primary end-point for this trial is Response Rate
with Overall Survival among the secondary endpoints.
- YM BioSciences, the licensor of nimotuzumab, anticipates that it
will extend the European trial in pancreatic cancer into Canada by
submitting the protocol to Canadian health regulatory authorities to
add Canadian site to accelerate recruitment
Wedel, Germany, June 08 2007
ONCOSCIENCE AG ANNOUNCES FINAL RESULTS OF A
PHASE-II STUDY IN PEDIATRIC PATIENTS WITH RECURRENT HIGH-GRADE MALIGNANT
GLIOMA TREATED WITH THE MONOCLONAL ANTIBODY NIMOTUZUMAB DIRECTED AGAINST
EGF-R, AS MONOTHERAPY.
Final results of
the Phase II trial were described in an oral presentation at the Annual
Meeting of the American Society of Clinical Oncology (ASCO) on Sunday,
June 3rd 2007, in Chicago, by Professor Dr.
Udo Bode, University of Bonn, Germany, the Principal Investigator of the
study (Abstract #2006).
The trial included 47 heavily pre-treated patients with
a median age of 11 years of which 45 were evaluable for response (11
patients with anaplastic astrocytoma (AA) grade III, 13 with
glioblastoma multiforme (GBM) grade IV and 21 with diffuse intrinsic
pontine glioma (DIPG)). All the AA and GBM patients had undergone
surgery and were treated with radiation and multiple courses of
different chemotherapy. The DIPG patients were treated with radiation
and multiple courses of different chemotherapy.
The most important inclusion criteria were: documented
progressive disease by MRI (independently assessed by a reference
radiologist) at the time of entry into the study and expected survival
time of not less than four weeks.
Nimotuzumab monotherapy was administered at a dose of
150 mg/m² weekly for six weeks (an induction period) and, for patients
who had not progressed following induction period, treatment continued
once every three weeks until week 21 or disease progression
(consolidation period). First MRI assessment at week 8 shows 2 PR and 14
SD which results in a 35.6% response rate. Twelve out of 45 patients
entered for consolidation therapy; four partial responses (PR), two
stable disease (SD) and six disease progressions (PD) were reported. In
the 21 patients with DIPG an overall clinical benefit rate of 38.1% was
observed (1 PR, 7 SD) in the induction phase. In the consolidation phase,
four of the eight patients with DIPG received additional clinical
benefit (3 PR, 1 SD). The median survival in patients with clinical
benefit was three times longer (8.9 months compared to 3.3 month) as in
patients who did not respond to treatment. This length of survival in
patients with recurrent disease approaches the historical median
survival for newly diagnosed paediatric patients with high malignant
glioma. Even more important was the observation that in these end stage
patients the unexpectedly long median survival was accompanied by an
excellent quality of life. No drug related rash, diarrhoea,
conjunctivitis etc. (which normally is reported with use of EGFR
antibodies) has been seen. Some patients were no longer wheel chair
bound, and were able to feed themselves, attend kindergarten or school
and have long home rather than institutional care.”
Based on these results, a first line Phase-III study in
40 paediatric patients newly diagnosed with DIPG was initiated in March
2006 and recruitment is expected to be completed in Q3/2007.
Oncoscience AG is a private company in Germany focused
principally in oncology. Oncoscience AG licensed the monoclonal antibody,
nimotuzumab, from CIMAB and CIMYM Inc. a majority-owned subsidiary of YM
BioSciences Inc., in Canada.
Wedel, September 30th 20055
YM BioSciences partner Oncoscience AG reports
update of pediatric brain cancer data
Nimotuzumab (Theraloc;TheraCIM h-R3) Phase
II results awarded best poster prize at the 37th congress of
the International Society of Paediatric Oncology
Download: YM BioSciences pr9-27-05.pdf (20k) 
Wedel, March 1st 2005
YM BioSciences and Oncoscience Report Response Rate of 35.3% in
Pediatric Glioma
TheraCIM h-R3 (nimotuzumab) Phase II Results Presented at
European High Grade Glioma Conference
MISSISSAUGA, ON, Feb. 28 /PRNewswire-FirstCall/ - YM BioSciences Inc.
(AMEX:YMI, TSX:YM, AIM:YMBA) today announced that it has been advised by
its European partner, Oncoscience AG, that a Phase II trial in children
with brain cancer (glioma) utilizing the EGF receptor monoclonal
antibody TheraCIM h-R3 (nimotuzumab, "Theraloc" in Europe) as a
monotherapy achieved a response rate of 35.3%. Six of the 17 children
who were fully evaluable at the time of the conference were reported to
have demonstrated either stable disease or a partial response. Of the
six, four were identified by investigators to have been suffering from
pontine glioma (diffuse intrinsic brain stem glioma) - a form of the
disease that is particularly aggressive and generally untreatable. No
skin toxicity or allergic reactions were reported, consistent with all
the previous trials conducted with TheraCIM h-R3. These results were
formally presented on February 25th, 2005 at the "European High-Grade
Glioma Meeting" in Regensburg, Germany and a conference call to discuss
these data will be held today at 1:00pm EST.
Phase II Trial Results
The trial included 20 children who had been treated surgically for their
glioma and had also received radiation and mono chemotherapy or
combination chemotherapy treatment. They were entered into the trial
when all prior treatments had failed and progression had been documented
by MRI assessment. One child was determined to be ineligible and was
withdrawn. The trial's protocol required the trial to stop for futility
if no patients responded to the treatment with h-R3; to continue as
monotherapy if two patients responded, and to stop for success if at
least three patients responded to treatment with the antibody. At the
time of the conference, 17 of the 19 patients were available for
evaluation at eight weeks after induction therapy. Response was
documented by MRI in week eight and 21 after the start of therapy and
evaluated centrally using the RECIST criteria. Of the six children
(35.3%) in the trial who were reported to have responded to treatment,
five had stable disease and one was evaluated as a partial response. Of
the six patients diagnosed with intrinsic pons glioma at primary tumour
diagnosis, four children (66%) responded to treatment with the antibody.
One of the inclusion criteria was that patients had a minimum expected
lifespan of four weeks. The survival noted in the responding patients at
the time of the report were respectively: greater than 8.0; 5.0; greater
than 4.0; greater than 3.5; greater than 3.0; and 1.3 months, in
contrast to the non-responders who had a median and average lifespan of
1.15 months with a range of 0.3-2.0 months. No skin toxicity or allergic
reactions were reported. No severe hematological or non-hematological
side effects associated to the h-R3 antibody were noted and no side
effects were noted in 95% of patients. The trial was conducted at seven
of the 52 hospitals that compose the BFM (Berlin, Frankfurt and Munster)
Group of hospitals in Germany. The principal investigator was Prof. Dr.
U. Bode, Department of Pediatric Hematology/Oncology, University of
Bonn. The positive results of the trial permit Oncoscience to apply for
an IND to conduct a pivotal trial testing the combination of the h-R3
antibody with radiation against radiation alone for the first line
treatment of pediatric glioma. If approved, the pivotal trial could
start in Q2/2005, possibly include up to 100 patients and possibly
recruit all patients within 12 months following initiation. TheraCIM
h-R3/Theraloc/nimotuzumab is a humanized monoclonal antibody licensed
from CIMAB S.A., the corporation representing the Center of Molecular
Immunology in Havana.
YM and Oncoscience AG will host a teleconference on the data
presented at the European High-Grade Glioma Meeting on Monday, February
28, 2005 at 1:00pm EST which may be accessed by calling +1-416-695-7860
(from Europe) or 1-800-565-5185 (in North America) and utilizing the
participant code 261890.
About Oncoscience AG
Oncoscience AG is a private biotech company based in Germany and is
focused in Oncology (Theraloc), Organ Transplantation (Lifor) and Tumor
Banking including research in the Genome/Proteome field.
About YM BioSciences
YM BioSciences Inc. is a cancer drug development company. Its lead drug,
tesmilifene, is a small molecule chemopotentiator currently undergoing a
700-patient pivotal Phase III trial in metastatic and recurrent breast
cancer. Published results from tesmilifene's first Phase III trial
demonstrated a substantial increase in survival in the same indication
for women treated with the combination of tesmilifene and chemotherapy
compared to chemotherapy alone, which demonstrated that tesmilifene
significantly enhanced the therapeutic effect of chemotherapy. In
addition to tesmilifene, the Company is developing the EGFr humanized
monoclonal antibody described above and a GnRH anti-cancer vaccine that
is in earlier stage clinical trials.
Wedel, January 10th 2005
YM BIOSCIENCES AND ONCOSCIENCE ACHIEVE CLINICAL MILESTONE
Results Permit Pediatric Brain Cancer Trial to be Converted into Pivotal Randomized First-Line Therapy Trial
MISSISSAUGA, Canada - January 25, 2005 -
YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA) today announced that it has been advised by its European partner, Oncoscience AG, that the Phase II trial in children with brain cancer (glioma) utilizing the EGF receptor monoclonal antibody (h-R3) as a monotherapy achieved the clinical milestone that permits conversion of the trial into a pivotal trial in this
population.
The new study will be a randomized Phase III trial comparing radiation (the standard-of-care) to radiation plus h-R3 as a first-line therapy following surgery. YM has been advised that the trial is expected to enroll 100 patients and is targeted for completion in the second quarter of 2006. Results from the original trial will be formally presented at the "European High-Grade Glioma Meeting" on February 25-26, 2005 in Regensburg, Germany.
"Although the results are preliminary in nature, we have been advised that at least three patients responded to the treatment, allowing the early conversion of the trial into a more significant pivotal trial. This is a welcome and unanticipated result in a patient population for whom no other therapy is available and prognosis is very poor," said David Allan, Chairman of YM
BioSciences.
The study is being conducted in Germany by YM's partner in Europe, Oncoscience AG, and is the first trial of this antibody as a monotherapy and its first trial in
children.
"Early termination of the trial for success in this heavily pretreated patient group and the consequent ability to proceed to a first-line therapy study is more than expected. We are looking forward to seeing the entire data set in a few weeks," stated Ferdinand Bach, CEO of Oncoscience AG.
Eighteen children were recruited into the original trial and are available for response evaluation. Patients were treated with the humanized EGFr monoclonal antibody, nimotuzumab (TheraCIM h-R3 in North America and Theraloc in Europe). The patients, for whom the prognosis is extremely poor and the expected survival period short, had brain cancer which had progressed following all other available therapies (surgery, radiation and combination or mono-chemotherapy). Under the protocol, the trial would have been terminated if no patients had responded to the monotherapy. Alternatively, it would have continued as a monotherapy with an additional 29 patients if two of the 18 patients responded and moreover, would have been defined as having achieved a sufficient response if at least three patients responded to the treatment, permitting a follow-on trial with h-R3 as a first-line (post-surgery) therapy, combining the antibody with
radiation.
Commenting on these results, Dr. Paul Keane, Director of Medical Affairs at YM said, "Although the results are preliminary in nature, the early termination for success, i.e. exceeding the predefined threshold, thus allowing the initiation of a first-line therapy study in which the combination of antibody with radiation will be compared with radiation alone, is encouraging for the continued development of the drug. The combination of h-R3 with radiation has been shown effective in other trials, and these results are consistent with those obtained with other EGF receptor monoclonal
antibodies."
In previous clinical trials in adult glioma, head and neck cancer and nasopharyngeal cancer, TheraCIM h-R3/Theraloc has been shown to significantly improve the therapeutic effects of radiation. A report on one of these trials was published in the Journal of Clinical Oncology (Volume 22, #9, May 1, 2004) and other trials have been described in press releases by YM BioSciences Inc.
A parallel monotherapy trial, also being conducted in Germany in metastatic pancreatic cancer, was initiated at the end of November 2004, has enrolled 14 patients to date and is targeted to complete its first clinical assessment in mid-2005 following the review of the first 30 patients in that trial. Application has been made for a randomized trial in adults with glioma and the trial in children could be supportive of that
application.
Theraloc/TheraCIM has been awarded Orphan Drug designation by both the European health regulatory authority - EMEA - and by the FDA in the USA for treatment of
glioma.
H-R3 is licensed to YM's subsidiary, CIMYM, for Europe, North America and the Pacific Rim excluding China, by CIMAB S.A, the commercial arm of the Center for Molecular Immunology in
Havana.
YM and Oncoscience AG will host a teleconference on the data presented at the European High-Grade Glioma Meeting immediately following that conference on Monday, February 28, 2005 at 1:00pm EST and may be accessed by calling +1-416-695-7860 (from Europe) or 1-800-565-5185 (in North America) and utilizing the participant code 261890.
About YM BioSciences
YM BioSciences Inc. is a cancer drug development company. Its lead drug, tesmilifene, is a small molecule chemopotentiator currently undergoing a 700-patient pivotal Phase III trial in metastatic and recurrent breast cancer. Published results from tesmilifene's first Phase III trial demonstrated a substantial increase in survival in the same indication for women treated with the combination of tesmilifene and chemotherapy compared to chemotherapy alone which demonstrated that tesmilifene significantly enhanced the therapeutic effect of chemotherapy . In addition to tesmilifene, the Company is developing the EGFr humanized monoclonal antibody described above and a GnRH anti-cancer vaccine that is in earlier stage clinical
trials.
Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual
reporting.
Wedel, October 2004
Oncoscience AG announced a change in the board of directors
Oncoscience AG announced that Mrs. U. Bach, one
of the founder, has left the board of directors for personnel reasons.
The board of directors and the chairman thanked Mrs. Bach for the
outstanding work she has done in the early phase of Oncoscience.
The owner voted during the
shareholders’ general meeting in September 2004 unanimously for Mr.
M.Rüdiger (Chairman, Crédit Suisse Germany) as the new member on the
board of directors.The owner, board of Directors and the chairman of
Oncoscience are impressed that Mr. Rüdiger is willing to work for the
company and are highly motivated for the upcoming business.
Wedel, October 2004
Oncoscience AG established scientific advisory board
Oncoscience AG is proud to inform about the
establishment of the scientific advisory board with the first come together
mid September 2004.
Members are well known scientist
from different areas:
Prof. Dr. H. Allgayer
(experimental surgery)
Prof. Dr. F. Boeminghaus (Urology)
Prof. Dr. H. Schweim ( Pharmacology )
PD. Dr. D. Strumberg (Internal Oncology)
Chairman and the board of
directors are thankful to thee readiness to give advise to Oncoscience
AG in the different scientific and medical
areas the company is working.
Even in the first meeting the
are several different opinions which should play a role for future
decisions. The advisory board will be grown by
another at least two scientist in the very near future.
Wedel, August 10th 2004
YM BioSciences' EGFr antibody receives EU orphan drug designation through Oncoscience AG, its European partner
10.08.2004 - Mississauga. YM BioSciences Inc., the cancer drug
development company with an advanced-stage portfolio, and its
majority-owned subsidiary, CIMYM Inc., announced that their anti-cancer
drug TheraCIM hR3 has been designated an Orphan Drug by the European
Medicines Agency for the Evaluation of Medical Products (EMEA) for the
treatment of glioma. This designation was obtained by Oncoscience AG,
the Company's European development partner for the drug. TheraCIM hR3 is
licensed to YM's subsidiary CIMYM Inc. by the Center for Molecular
Immunology.
"Orphan drug status provides TheraCIM hR3 with up to ten years
of market exclusivity in Europe, greatly enhancing this product's
commercial potential," said David Allan, Chairman and CEO of YM
BioSciences. "It also ensures that assistance in meeting European
regulatory requirements is provided, strengthening our regulatory
position for this important cancer drug."
TheraCIM hR3, a humanized monoclonal antibody, is licensed as "Theraloc"
to Oncoscience AG for Europe and is currently in a Phase I/II trial in
paediatric glioma, a form of brain cancer, for which the first patients
were recruited in June 2004. Oncoscience is proposing to initiate
several additional studies for TheraCIM hR3, including a Phase III
registration trial in adult glioma that is anticipated to start in Q4,
2004 and a Phase II trial in metastatic pancreatic cancer also
anticipated to start in Q4, 2004. Results of a previous Phase I/II trial
for TheraCIM hR3 were published in the Journal of Clinical Oncology on
May 1, 2004.
"The combination of this orphan drug designation immediately
preceding the launch of a Phase III registration trial in the designated
indication is highly significant for the development of this drug,"
said Ferdinand Bach, CEO of Oncoscience. "We are especially proud
to have obtained this designation within only six months thanks to the
excellent work of our dedicated team."
On July 15, 2004, YM BioSciences announced that an agreement between
it and CancerVax Corporation of San Diego, CA for two other cancer
products it licensed from the Centre of Molecular Immunology was
approved by the US Treasury Department.
YM BIOSCIENCES INC.
© Bionity.COM / Chemie.DE Information Service GmbH http://www.bionity.com/news/details.php3?cmid=39017&language=e
Wedel, June 30th 2004
Orphan-Drug-Designation finalised
Oncoscience AG announces that it finalised the Orphan-Drug-Designation for its monoclonal antibody h-R3
(Theraloc) with the European Agency (Emea) on June, 24th 2004. Oncoscience AG is waiting for a decision within the next three
months.
Wedel, June 11th 2004
Phase-II-Study started
Oncoscience AG announces the start of the Phase-II-Study - Therapy of high malignant gliomas by
children. 27 hospitals in Germany are participating in this protocol. In a
two-step-version, a maximum of 47 patients has to be enrolled in that
trial. They will be treated after the first recurrence with the monoclonal antibody h-R3
(Theraloc). The first patient has already been recruited.
Wedel, March 2004
AACR annual meeting 2004 - Late breaking news
read the abstract "Establishing continuous single cell
cultures from primary tumor excisions using a new generation of tumor
tissue transport- and culture solution", that will be presented
during AACR annual
meeting 2004 in Orlando / Florida.
Download:
AACR_2004.pdf (32k) 
Wedel / MISSISSAUGA, Kanada, November 2003
Oncoscience signs contract with YM Biosciences Inc.
Read the press release
Download:
press_release_YM_Biosciences.pdf (27k) 
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