Press Release
Press Release 2010/08/03
Antisense Pharma obtains IND for clinical studies in the USA
Press Release 2010/04/18
Scientific abstract on the Phase IIb study with trabedersen has been distinguished as one of the best by the AACR
Press Release 2010/03/09
Antisense Pharma receives patent protection for the use of the drug trabedersen until 2026 – and raises equity of 13 million Euros
Press Release 2009/10/19
Health Canada approves Antisense Pharma`s clinical Phase III study SAPPHIRE in aggressive brain tumors
Press Release 2009/09/14
FDA and EMEA grant orphan drug designation for Antisense Pharma’s investigational drug trabedersen in pancreatic carcinoma
Press Release 2009/06/02
Antisense Pharma announces new data on its lead compound at ASCO 2009, including the design of the Phase III SAPPHIRE study currently ongoing in high-grade glioma
Press Release 2009/04/27
Antisense Pharma begins pivotal Phase III clinical trial with trabedersen in aggressive brain tumors
Press Release 2008/06/02
Clinical Proof of Concept for TGF-beta 2-Inhibitor AP 12009 in Phase IIb - EMEA provides Guidance on Phase III Design and Approval Requirements
Press Release 2008/06/02
Anti-TGF-beta Antisense AP 12009 shows very good Safety and Tolerability in Systemic Treatment of Pancreatic Carcinoma, Malignant Melanoma and Colorectal Carcinoma
Press Release 2007/12/19
Antisense Pharma with new Management Structure
Press Release 2007/11/08
EUR 27 Million/USD 38 Million Venture Capital for Specialist in Cancer Therapeutics
Press Release 2007/06/21
Antisense Pharma: Promising Phase IIb Results of Targeted Therapy with AP 12009 in Recurrent Anaplastic Astrocytoma
Press Release 2007/06/21
Encouraging First Results on TGF-beta 2 Inhibitor AP 12009 in the Systemic Treatment of Pancreatic Carcinoma, Malignant Melanoma and Colorectal Carcinoma
Press Release 2007/05/10
2007 ASCO Annual Meeting - Clinical Results on Phase IIb-study with AP 12009 in Anaplastic Astrocytoma selected for Poster Discussion
Press Release 2007/05/10
2007 ASCO Annual Meeting - Phase I/II-data on systemic application of the TGF-beta2-inhibitor AP 12009 to be presented
Press Release 2006/11/21
Antisense Pharma GmbH welcomes Hubert Heinrichs to the Executive Board
Press Release 2006/05/18
Phase I/II-trial expanded: TGF-beta2-Inhibitor AP 12009 for Colorectal Carcinoma and Malignant Melanoma Patients
Press Release 2005/11/30
Antisense Pharma raises $ 18 Million in Venture Financing
Press Release 2005/02
Antisense Pharma announces start of clinical phase I/II study for systemic administration of AP 12009 in cancer patients
Press Release 2004/07
Antisense Pharma wins German Founders Award for development of innovative cancer therapy
Press Release 2004/05
Innovation Award for Antisense Pharma
Press Release 2004/05/13
ASCO Accepts Antisense Pharma`s Clinical Phase I/II Results of AP 12009 in High-Grade Glioma for Oral Poster Discussion at the 2004 Annual Meeting
Press Release 2004/04/29
Antisense Pharma Announces Closing of 16.5 Million Euro Financing
Press Release 2003/11/27
Antisense Pharma GmbH Raises 6.5 Million Euro in Ongoing Financing Round
Press Release 2003/10/02
Antisense Pharma Presents Positive Preclinical Results of AP 12009 in Pancreatic Cancer at ECCO 2003
Press Release 2003/09/04
Antisense Pharma GmbH sticks to its Policy: Classical Antisense PTOs against Key Multimodal Targets
Press Release 2003/05/16
Complete Clinical Results of Phase I/II Studies with AP 12009 for Glioma will be presented at 2003 Annual Meeting of ASCO
Press Release 2003/04/10
AP 12009 to Start Phase IIb Study In Recurrent Malignant Brain Tumors after Excellent Phase I/II Results
Press Release 2003/03/20
Target Confirmation - Special conference devoted solely to Antisense Pharma`s central drug target TGF-beta
Press Release 2002/09/06
Antisense Pharma Presents AP 12009 Brain Cancer Studies At EANO
Press Release 2002/07/09
Antisense Pharma Receives U.S. Orphan Drug Status for its Brain Cancer Drug
Press Release 2002/06/04
Results From Phase I/II Study For AP 12009 In Malignant Brain Tumors
Press Release 2002/04/29
First Clinical Data at ASCO Meeting
Press Release 2002/04/15
Antisense Pharma Receives Orphan Drug Status for AP 12009 in High-Grade Glioma
Press Release 2002/03/11
Phase I/II Data Presented on AP 12009 in Glioma Patients
Press Release 2001/10/15
Antisense Pharma licenses Biognostik's Anticancers
Press Release 2001/06/01
Lead Cancer Compound AP 12009 in Phase I/II
... from Discovery to Market
... Products
... Management and Strategy
Press Release 2010/08/03
Antisense Pharma obtains IND for clinical studies in the USA
Regensburg, August 03, 2010 – The biopharmaceutical company Antisense Pharma announced today that the US-American Food and Drug Administration (FDA) has issued an Investigational New Drug (IND)-authorisation for clinical studies with trabedersen for patients with high-grade glioma. This authorisation entitles the company to include US-American clinics both in the phase III study SAPPHIRE and in further studies.
Press Release 2010/08/18
Scientific abstract on the Phase IIb study with trabedersen has been distinguished as one of the best by the AACR
Regensburg/Washington - April 18, 2010 - The American Association for Cancer Research (AACR) made their choice from 6,300 abstracts which had been submitted.
Press Release 2010/04/09
Antisense Pharma receives patent protection for the use of the drug trabedersen until 2026 – and raises equity of 13 million Euros
Regensburg, March 09, 2010 – The European Patent Office has granted the biopharmaceutical company Antisense Pharma additional patent protection for the use of its flagship product trabedersen. The company is a specialist in the development of targeted therapies for particularly aggressive cancers. This patent gives Antisense Pharma a comprehensive marketing exclusivity for the use of this drug within the settings of tumour-illnesses, illnesses of the central nervous system and immunosuppression, taking into consideration the effective dose.
Press Release 2009/10/19
Health Canada approves Antisense Pharma`s clinical Phase III study SAPPHIRE in aggressive brain tumors
Regensburg, October 19, 2009 - The biopharmaceutical company Antisense Pharma GmbH has announced today that it has received the approval by Health Canada for its pivotal Phase III clinical trial SAPPHIRE in patients with recurrent or refractory anaplastic astrocytoma. The SAPPHIRE study is a randomized, active-controlled, clinical trial designed to confi rm the effi cacy and safety of the investigational drug trabedersen (AP 12009), observed in previous clinical studies. Trabedersen is being investigated as monotherapy compared to current standard therapy with temozolomide (alternatively BCNU [carmustine]). The results of a previous randomized, active-controlled Phase IIb study show that the novel, targeted therapy holds significant promise. Currently recruiting study centers will be published on www.anticancer.de.
Press Release 2009/09/14
FDA and EMEA grant orphan drug designation for Antisense Pharma’s investigational drug trabedersen in pancreatic carcinoma
Regensburg, Germany – September 14, 2009. The biopharmaceutical company Antisense Pharma GmbH has announced today that it has received orphan drug designation from both the European Medicines Agency EMEA and the US Food and Drug Administration FDA for its investigational drug trabedersen in the treatment of pancreatic carcinoma. Trabedersen has already been granted orphan drug designation by both authorities in the treatment of high-grade gliomas in 2002. This underlines the high potential of trabedersen to treat various aggressive tumors.
Press Release 2009/06/02
Antisense Pharma announces new data on its lead compound at ASCO 2009, including the design of the Phase III SAPPHIRE study currently ongoing in high-grade glioma
ORLANDO - June 2nd 2009 - Trabedersen (AP 12009), a first in class investigational therapy for the treatment of aggressive tumors, showed a good safety and tolerability profile and encouraging survival data in patients with pancreatic carcinoma, malignant melanoma and colorectal carcinoma. Data from a Phase I/II study, announced at the American Society of Clinical Oncology (ASCO) 2009, will lead to further clinical studies. Currently an additional 24 patients with pancreatic carcinoma or malignant melanoma are being recruited to confirm the promising efficacy and safety results with trabedersen.
Press Release 2009/04/27
Antisense Pharma begins pivotal Phase III clinical trial with trabedersen in aggressive brain tumors
REGENSBURG – April 27, 2009 – The biopharmaceutical company Antisense Pharma GmbH has announced today that the first patients with recurrent or refractory anaplastic astrocytoma have been enrolled in the pivotal Phase III clinical trial SAPPHIRE. The SAPPHIRE study is a randomized, active-controlled, clinical trial designed to confirm the efficacy and safety of the investigational drug trabedersen (AP 12009), observed in the previous clinical studies. Trabedersen is being investigated as monotherapy compared to current standard therapy with temozolomide (alternatively BCNU). The results of the previous randomized, active-controlled Phase IIb study show that the novel, targeted therapy holds much promise.
Press Release 2008/06/02
Clinical Proof of Concept for TGF-beta 2-Inhibitor AP 12009 in Phase IIb - EMEA provides Guidance on Phase III Design and Approval Requirements
CHICAGO/REGENSBURG - June 2, 2008 - "A two-year survival rate of more than 80 percent in recurrent or refractory anaplastic astrocytoma suggests a breakthrough in this devastating disease by targeted therapy," commented Prof. Ulrich Bogdahn, Neuro-Oncologist and Coordinating Investigator of the Phase IIb active-controlled dose-finding trial with
AP 12009 in recurrent or refractory high-grade glioma, while presenting the data at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, USA, today. The 24-month survival rate was accepted by the Scientific Advice Working Party (SAWP) at the EMEA as the primary endpoint for the upcoming Phase III study in recurrent or refractory anaplastic astrocytoma patients. Furthermore, 14-month progression rate was accepted as the endpoint for conditional approval.
Press Release 2008/06/02
Anti-TGF-beta Antisense AP 12009 shows very good Safety and Tolerability in Systemic Treatment of Pancreatic Carcinoma, Malignant Melanoma and Colorectal Carcinoma
CHICAGO/REGENSBURG - June 2, 2008 - The TGF-beta 2 inhibitor AP 12009, developed by Antisense Pharma, reveals very good safety and tolerability in the systemic treatment of pancreatic carcinoma, malignant melanoma and colorectal carcinoma. AP 12009, administered intravenously, showed a clear proof of concept. Patients with stage IV pancreatic carcinoma, who received AP 12009 for seven days every other week as second or third line therapy, had a median survival time of 29.6 weeks (6.8 months) after start of AP 12009 treatment. One of these patients with several liver metastases even experienced a complete response. Efficacy and safety results of the multicenter Phase I/II study were published today at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, USA.
Press Release 2007/12/19
Antisense Pharma with new Management Structure
Regensburg, December 19, 2007 – Antisense Pharma announced today that Dr. Reimar Schlingensiepen, Managing Director and cofounder, has stepped down as Chief Operating Officer effective 30.11.2007. He will remain a shareholder and will continue to support the company in an advisory capacity. Dr. Karl-Hermann Schlingensiepen, Chief Executive Officer, has now assumed sole leadership of Antisense Pharma.
Press Release 2007/11/08
EUR 27 Million/USD 38 Million Venture Capital for Specialist in Cancer Therapeutics
Regensburg/Munich, November 8, 2007 – Antisense Pharma GmbH, biotech leader in the development of targeted therapies for malignant tumors, receives venture capital amounting to EUR 27 million (USD 38 million) from the VC-funds of the MIG AG. The company will employ these funds to foster the development of its lead compound AP 12009 towards approval. Preparations for the last clinical trial phase are under way.
Press Release 2007/06/21
Antisense Pharma: Promising Phase IIb Results of Targeted Therapy with AP 12009 in Recurrent Anaplastic Astrocytoma
CHICAGO and REGENSBURG - June 21, 2007 - “In anaplastic astrocytoma, AP 12009 as a monotherapy is actually clearly superior to temozolomide,” Prof. Albert Wong, M.D., Stanford University, California, U.S.A. commented on the international Phase IIb study with the TGF-beta 2-inhibitor AP 12009, under development by Antisense Pharma. Prof. Wong discussed the results of the study in the poster discussion session on central nervous system tumors at the 43rd Annual Meeting of the American Society of Clincal Oncology (ASCO) in Chicago, USA, this month.
Press Release 2007/06/21
Encouraging First Results on TGF-beta 2 Inhibitor AP 12009 in the Systemic Treatment of Pancreatic Carcinoma, Malignant Melanoma and Colorectal Carcinoma
CHICAGO and REGENSBURG - June 21, 2007 - The TGF-beta 2 inhibitor AP 12009, under development by Antisense Pharma, reveals very good safety and tolerability in the systemic treatment of Pancreatic Carcinoma, Malignant Melanoma and Colorectal Carcinoma. Interim results of a Phase I/II study have been presented at this year´s Annual Meeting of the American Society of Clincal Oncology (ASCO) in Chicago, USA.
Press Release 2007/05/10
2007 ASCO Annual Meeting - Clinical Results on Phase IIb-study with AP 12009 in Anaplastic Astrocytoma selected for Poster Discussion
Antisense Pharma, a German biopharmaceutical company specialized in targeted therapies for malignant tumors, today announced, that data from the Phase IIb-study with AP 12009 in high-grade glioma will be presented at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO), which will be held in Chicago, Illinois, U.S.A, from June 1st - 5th.
Press Release 2007/05/10
2007 ASCO Annual Meeting - Phase I/II-data on systemic application of the TGF-beta2-inhibitor AP 12009 to be presented
Antisense Pharma today announced, that the abstract entitled “Preliminary Results of a Phase I/II-Study in Pancreatic Carcinoma, Malignant Melanoma, and Colorectal Carcinoma with the TGF-beta2 Inhibitor AP 12009” has been selected for poster presentation at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO), which will be held in Chicago, Illinois, U.S.A, from June 1st - 5th.
Press Release 2006/11/21
Antisense Pharma GmbH welcomes Hubert Heinrichs to the Executive Board
Regensburg, Germany, November 21st, 2006 - Antisense Pharma, a German biopharmaceutical company developing targeted therapies for malignant tumors, announced the appointment of Hubert Heinrichs, M.D., to its executive board. Hubert Heinrichs, with a strong background and vast experience in the pharmaceutical industry, especially in drug approvals, joins the founders Karl-Hermann Schlingensiepen and Reimar Schlingensiepen, expanding the executive board to three members.
Press Release 2006/05/18
Phase I/II-trial expanded: TGF-beta2-Inhibitor AP 12009 for Colorectal Carcinoma and Malignant Melanoma Patients
“The first patients with colorectal carcinoma (CRC) entered our phase I/II-study for the systemic treatment of malignant tumors with AP 12009”, announced Hubert Heinrichs, M.D., Chief Medical Officer of Antisense Pharma today.
Press Release 2005/11
Antisense Pharma raises $ 18 Million in Venture Financing
Regensburg, Germany, November 30th, 2005 - Antisense Pharma announces today that it has raised $ 18.0 million in private equity from the German MIG funds. This investment further validates Antisense Pharma´s worldwide leadership in the field of antisense technology and its application, the development of targeted anticancer drugs.
Press Release 2005/02
Antisense Pharma announces start of clinical phase I/II study for systemic administration of AP 12009 in cancer patients
Regensburg, Germany, February 10th, 2005 - “The first patient with pancreatic carcinoma has just been included into the clinical phase I/II study for the systemic administration of our lead compound AP 12009. Thus, the clinical development of our drug in further malignant tumor indications progresses as expected”, explains Dr. Karl-Hermann Schlingensiepen, Chief Executive Officer of Antisense Pharma GmbH.
Press Release 2004/07
Antisense Pharma wins German Founders Award for development of innovative cancer therapy
REGENSBURG/BERLIN, GERMANY - July 2004. The founders of Antisense Pharma Dr. Karl-Hermann Schlingensiepen and Dr. Reimar Schlingensiepen received the German Founders Award on June 22nd, 2004 in Berlin. The award is a tribute to their achievements in the development of innovative therapies against cancer.
Press Release 2004/05
Innovation Award for Antisense Pharma
REGENSBURG, GERMANY - May 2004. Antisense Pharma GmbH receives the Bavarian Innovation Award 2004. The Bavarian State Minister, Dr. Otto Wiesheu, awarded the prize endowed with 100,000 EUR (almost 125,000 USD) on May 18th, 2004, during a ceremony in the State Chancellery in Munich.
Press Release 2004/05/13
ASCO Accepts Antisense Pharma`s Clinical Phase I/II Results of AP 12009 in High-Grade Glioma for Oral Poster Discussion at the 2004 Annual Meeting
REGENSBURG, GERMANY - May 13th, 2004. Antisense Pharma GmbH announced today that data from the Company’s phase I/II AP 12009 trials in high-grade glioma have been accepted as the subject of a poster discussion session at the 2004 Annual Meeting of the American Society of Clinical Oncology (ASCO). The meeting will take place in New Orleans, Louisiana, June 5-8. Poster discussion sessions at ASCO annual meetings highlight extraordinary clinical research results out of thousands of submitted abstracts.
Press Release 2004/04/29
Antisense Pharma Announces Closing of 16.5 Million Euro Financing
REGENSBURG, GERMANY - April 29th, 2004. Antisense Pharma today announced that it has successfully raised 10 million EUR within the second closing of its current expansion financing, now totalling to 16.5 million EUR. Investors in this second closing include the Global Chance Fund and the Global Asset Fund. The previous closing included investments from Global Chance Fund, S-Refit AG, Technologie-Beteiligungsfonds Bayern, as well as private investors.
Press Release 2003/11/27
Antisense Pharma GmbH Raises 6.5 Million Euro in Ongoing Financing Round
REGENSBURG, GERMANY - November 27th, 2003. Antisense Pharma GmbH today
announced that the company has secured 6.5 million EURO in first closing
of the current financing round, including funding from existing investors,
S-Refit AG and TBF, as well as from private investors. The German Global
Chance Fund (GCF) signed an investment in a total of 3 million EURO.This
closing is the first step of Antisense Pharma’s ongoing expansion
financing. It ensures the clinical development of the company’s lead
product AP 12009 for the treatment of high-grade glioma, as well as bringing
further promising drug candidates
into the clinics.
Press Release 2003/10/02
Antisense Pharma Presents Positive Preclinical Results of AP 12009 in Pancreatic Cancer at ECCO 2003
REGENSBURG, GERMANY - October 2nd, 2003. Antisense Pharma GmbH presented
preclinical data of AP 12009 in pancreatic carcinoma at last week’s
12th European Cancer Conference (ECCO) in Copenhagen, Denmark, Sep 21st
- 25th, 2003. Based on these results a clinical trial with AP 12009 in
pancreatic carcinoma is currently in preparation. The company’s lead
product AP 12009 is already being studied in phase IIb for the treatment
of high-grade glioma. AP 12009 efficiently represses the production of
TGF-β2 (transforming growth factor-β2).
The antisense oligonucleotide AP 12009 interacts with the mRNA of TGF-β2
thus inhibiting the production and in consequence the functional activity
of the cancer protein at its earliest.Like in brain tumors the aggressiveness
and poor prognosis in pancreatic cancer strongly correlates with the over-expression
of the most potent immunosuppressant, TGF-β2.
By inducing immunosuppression, promoting metastasis and increasing
tumor growth TGF-β2 plays a unique
role in the disease progression of pancreatic cancer.
Press Release 2003/09/04
Antisense Pharma GmbH sticks to its Policy: Classical Antisense PTOs against Key Multimodal Targets
(Regensburg, September 4th, 2003) Antisense Pharma clearly focuses on
the drug development for cancer treatment by combining precise selection
of key cancer target molecules and DNA based phosphorothioate oligonucleotides
(PTO). This
policy is confirmed by the positive data from phase I/II high-grade glioma
clinical trials of the company’s lead product, AP 12009.“Most
of the antisense drugs currently under development target tumor factors
that do not play a central role in tumor progression. Thus, their inhibition
can be easily compensated by tumor defense mechanisms” said Dr. Gerhard
Stauder, Chief Scientific Officer of Antisense Pharma. “This might
be the main reason for the unsatisfactory results of clinical trials with
an anti-PKC-a molecule”. In contrast, the drugs of Antisense Pharma
target key tumor factors, such as the most potent immunosuppressor Transforming
Growth Factor-beta (TGF-β), thus
reversing the tumor induced immunoblockade as well as inhibiting tumor
proliferation and metastasis. Antisense Pharma believes, that choosing
the right target for antisense drugs is as important for the clinical
success as for therapeutic antibodies.
Press Release 2003/05/16
Complete Clinical Results of Phase I/II Studies with AP 12009 for Glioma will be presented at 2003 Annual Meeting of ASCO
REGENSBURG, GERMANY - May 16th, 2003. Antisense Pharma GmbH will present
positive results from three Phase I/II clinical trials of AP 12009 at
the 39th Annual Meeting of the American Society of Clinical Oncology (ASCO)
in Chicago, IL, U.S.A.
May 31st - June 3rd 2003. The complete results of the first two studies
and preliminary data of the third study will be presented on Sunday, June
1st, 2003, 2:00 P.M. - 5:30 P.M., in Session GP19 ‘Central Nervous
System’, Abstract ID #436, Poster Board J5 by Dr. Gerhard Stauder,
Chief Scientific Officer of Antisense Pharma GmbH .In the first phase
I/II dose escalation study, 18 patients with high-grade glioma had been
treated intratumorally with a single course of the TGF-β2
antisense phosphorothioate oligonucleotide AP 12009. In a second study,
2 patients received a second course of AP 12009. In a third study, up
to ten courses of AP 12009 were applied to 7 patients.
Press Release 2003/04/10
AP 12009 to Start Phase IIb Study In Recurrent Malignant Brain Tumors after Excellent Phase I/II Results
REGENSBURG, GERMANY - April 10, 2003. Antisense Pharma GmbH announces
the start of a Phase IIb clinical trial with its AP 12009 targeting TGF-beta2.
This multi-national, open-label randomized controlled parallel-group study
will comprehend more than 20 trial sites in Western and Eastern Europe,
India and Israel and is expected to recruit 150 patients with recurrent
high-grade glioma.
AP 12009 has been developed to block the excess expression of transforming
growth factor-beta2 (TGF-beta2), which is known to correlate with bad
prognosis in high-grade glioma and other tumors. TGF-beta overexpression
leads to progression from a localized tumor to metastatic cancer. The
data have shown excellent safety and tolerability. Within a more than
100-fold escalation of the initial dose the substance showed an excellent
safety profile and no drug related lab changes were observed.
The primary endpoint of the study was to determine safety and tolerability.
Surpassing this objective, efficacy data were obtained. Patients having
received the widely used chemotherapy temozolomide (TMZ) before AP 12009
were compared to data from TMZ registration studies: the median overall
survival was 106.4 weeks as compared to 42 weeks with TMZ alone in patients
with anaplastic astrocytoma, and 46.1 weeks as compared to 32 weeks in
glioma patients. These results were achieved in spite of the terminal
stage of the enrolled patients, their mostly large tumor sizes and following
only one course of AP 12009 therapy, two patients having received two
courses. A patient having shown a complete response is still alive more
than two years after the treatment. Moreover, the complete remission of
the tumors in the other hemisphere and at more distant sites than that
of the original lesion and which were not directly exposed to AP 12009
infusion is a proof of concept of the reactivation of the immune response
after downregulation of TGF-beta2 by AP 12009. “To our knowledge, this
complete remission in all tumor sites after local treatment is exceptional
and has not been described before”, comments Dr. Stauder, CSO at Antisense
Pharma GmbH. All patients of the first trial were treated with AP 12009
via an intra-tumoral catheter to bypass the blood brain barrier. Both
operable and inoperable patients had been enrolled. All of them had received
at least one previous chemotherapy, usually temozolomide.
High-grade glioma is the most malignant brain tumor in man. These patients
need new treatment options as their survival rates are still poor, and
chemotherapy and radiation therapy have significant and often permanent
side effects. Patients with progressive tumor growth have an impaired
immune function. The key way for tumors to escape immune surveillance
is by overexpressing TGF-beta (transforming growth factor), the strongest
immunosuppressor known. The antisense AP 12009 targets this central factor
of cancer cell proliferation and survival.
"We are excited about the clinical data supporting our therapeutic concept.
Based on these data the international Phase II trial with an active control
arm in leading clinical centers has just been initiated." said Dr. Karl-Hermann
Schlingensiepen, Chief Executive Officer at Antisense Pharma GmbH. “The
results also strongly endorse our development program for AP 12009 in
other solid tumors."
Antisense Pharma GmbH is a German biotech company engaged in the research,
development, and marketing of antisense pharmaceuticals to overcome highly
unmet needs by treating especially malignant, advanced cancer.
For information, please visit the website at www.antisense-pharma.com
Press Release 2003/03/20
Target Confirmation - Special conference devoted solely to Antisense Pharma`s central drug target TGF-beta
(Regensburg, March 20th, 2003). The strategy of Antisense Pharma GmbH
to focus on transforming growth factor beta (TGF-β)
as a unique drug target and on phosphorothioate oligonucleotides (PTO)
has impressingly been confirmed at two recent conferences, the TGF-βconference
of the American Association of Cancer Research (AACR) in San Diego and
the SiRNA Design and Application conference in London.
The AACR conference “The TGF-ß superfamily: Roles in the pathogenesis
of cancer and other diseases” has highlighted the unique role of TGF-βfor
turning localized tumors into aggressive metastatic disease. The AACR
conference on TGF-βhas impressively
demonstrated its key role in the malignancy of cancer by regulating four
main pathomechanisms, i.e. tumor growth, angiogenesis, immunosuppression
and metastasis. Antisense Pharma GmbH had realized this crucial role of
TGF-βearly on and has focused
a large portion of its drug development program on the development of
antisense-TGF-βinhibitors for
the treatment of malignant forms of cancer. This has given the company
a head-start before its competitors as reflected by the advanced stage
of development: Its lead molecule AP 12009 is the most advanced anti-TGF-βcompound
for cancer treatment and has successfully passed phase I/II clinical studies
as therapy for high-grade glioma. These studies not only revealed excellent
safety and tolerability of AP 12009 but resulted in proof of concept efficacy
data as well. A phase II study has been initiated.
The superiority of antisense PTO drugs as therapeutics has again been
demonstrated at the recent SMi conference "Antisense and SiRNA technologies"
in London. Compared to other approaches like SiRNA only PTOs are extensively
validated in clinical applications. Characterized by their excellent balance
of properties from good cellular uptake to favourable pharmacokinetics
combined with an established and cost-effective manufacturing process
PTOs take the lead in antisense and oligonucleotide therapeutics. Antisense
Pharma GmbH has several PTO drug candidates in preclinical and clinical
development. PTOs reveal excellent clinical results as exemplified by
AP 12009: In his clinical trial update "Targeting cancer by reversing
immunosuppression" Reimar Schlingensiepen, COO of Antisense Pharma GmbH
not only pinpointed the potency of antisense-TGF-βdrugs for the treatment of presently uncurable cancer forms but
also proved the potential of PTOs. Antisense Pharma GmbH is determined
to further expand its leading position by extending the clinical use of
antisense TGF-βinhibitors to
other cancer indications.
Antisense Pharma GmbH is the leader in antisense drug development in Europe.
The company focuses on the research and development of novel anticancer
agents and aims to become a leading player in the market of therapeutics
for treating malignant tumors.
This press release contains forward-looking statements with respect to
the future business of Antisense Pharma GmbH. By their nature, forward-looking
statements and forecasts involve risks and uncertainties because they
relate to events and depend on circumstances that could occur in the future.
There are a number of factors that could cause actual results and developments
to differ materially. Antisense Pharma GmbH disclaims any intent or obligation
to update any of these forward-looking statements.
Press Release 2002/09/06
Antisense Pharma Presents AP 12009 Brain Cancer Studies At EANO
REGENSBURG, GERMANY – September 6, 2002. Antisense Pharma GmbH reports
that results of a phase I/II clinical study investigating the use of AP
12009 in patients with the most aggressive primary brain tumor, high-grade
glioma, showed excellent safety and tolerability. Surpassing the primary
endpoint of the study, first efficacy data were obtained. The observed
effects on the tumor including remission are a clinical proof of concept
of an immune activation by AP 12009. Both preclinical and clinical results
will be presented on September 10th at the Fifth Congress of the European
Association for Neuro-Oncology (EANO) in Florence, Italy.
Presentations:
1. Antisense OLIGONUCLEOTIDE AP 12009 SPECIFIC FOR mRNA ENCODING HUMAN
TRANSFORMING GROWTH FACTOR BETA2 (TGF-BETA2) IN THE THERAPY OF MALIGNANT
GLIOMAS IN VITRO. Jachimczak P, Schlingensiepen KH, Schlingensiepen R,
Bischof A, Hafner M, Schiller W, Szyrach M, Graf K, Kielmanowicz M, Stauder
G, Hau P, and Bogdahn U. Oral Presentation #206 , 12:15 a.m. , 10 Sep
2002.
2. RESULTS OF CLINICAL I/II DOSE ESCALATION STUDY USING THE TGF-BETA2
Antisense OLIGONUCLEOTIDE AP 12009 ADMINISTERED INTRATUMORALLY TO PATIENTS
WITH HIGH-GRADE GLIOMA. Hau P, Bogdahn U, Steinbrecher A, Zellner A, Schulmeyer
F, Brawanski A, Goldbrunner M, Kunst M, Stauder G, Jachimczak P, Schlingensiepen
KH, Schlingensiepen R. Poster #181, 1:30 p.m., 10 Sep 2002.
3. RESULTS OF SAFETY PharmaCOLOGY AND TOXICOLOGICAL STUDIES WITH THE TGF-BETA2
Antisense OLIGONUCLEOTIDE AP 12009. Stauder G, Schlingensiepen KH, Goldbrunner
M, Jachimczak P, Schulmeyer F, and Schlingensiepen R. Poster #399, 1:30
p.m., 10 Sep 2002
4. EFFECTS OF TGF-BETA Antisense OLIGONUCLEOTIDES ON GENE EXPRESSION OF
GLIOBLASTOMA CELLS. Nickl-Jockschat T, Apfel R, Glasbrenner E, Jachimczak
P, Giegerich G, Bogdahn U. Poster #290, 1:30 p.m., 8 Sep 2002.
Antisense Pharma’s business objective is the research, drug development
and commercialization of antisense therapeutics for the treatment of cancer.
The company applies its longstanding expertise in antisense and oncology
in developing a portfolio of antisense compounds to either license them
out or commercialize by its own. The company focuses specially, but not
only, on the key anticancer target, transforming growth factor-beta (TGF-beta).
In a variety of cancers, elevated levels of TGF-beta are correlated with
malignancy, invasiveness, metastasis and poor clinical prognosis.
Press Release 2002/07/09
Antisense Pharma Receives U.S. Orphan Drug Status for its Brain Cancer Drug
REGENSBURG, GERMANY - July 9th, 2002. The German biopharmaceutical company
Antisense Pharma GmbH announced today that the Office of Orphan Products
Development (OOPD) of the United States Food and Drug Administration (FDA)
has granted orphan drug designation for its TGF-β2
specific antisense oligodeoxynucleotide (AP 12009) in the treatment of
malignant glioma, the most common and aggressive primary brain tumor in
man. AP 12009 is the company's most advanced drug in clinical development,
currently being studied in an European Phase I/II clinical trial.
"This designation is very gratifying for us, as it clearly supports
our aim of developing novel treatments to effectively address unmet medical
needs in underserved markets," said Dr. Gerhard Stauder, Chief Scientific
Officer of Antisense Pharma. The orphan drug program is intended to encourage
research, development and approval of products that affect fewer than
200,000 patients in the United States. Orphan drug designation allows
Antisense Pharma exclusive marketing rights for AP 12009 in the US for
seven years following marketing approval by the FDA. The designation also
enables Antisense Pharma to apply for clinical research funding, tax credits
on clinical research and development expenses, potential waiver of user
fees associated with filing of the marketing application as well as for
assistance from the OOPD in guiding the drug through the regulatory approval
process.
Malignant glioma (glioblastoma and anaplastic astrocytoma, WHO grades
IV and III) is affecting approximately 20,000 patients in the Unites States.
The current standard therapy schemes are not sufficient to improve significantly
the survival time of the patients or the time to progression. In March
2002 Antisense Pharma GmbH received orphan drug designation from the Commission
of the European Communities for AP 12009. "The designations for both
the EU and the US will help in the development process of AP 12009 and
in significantly strengthening its market position in the future"
said Dr. Reimar Schlingensiepen, Chief Operating Officer. AP 12009 is
a highly specific phosphorothioate antisense inhibitor of TGF-β2
production. TGF-β2 (transforming
growth factor-beta 2) is the most potent immunosuppressor described to
date. In a variety of cancers elevated plasma levels of TGF-β2
are correlated with malignancy, invasiveness, metastasis and poor clinical
prognosis. In clinical phase I/II studies with malignant glioma patients
AP 12009 shows excellent safety and tolerability. Safety and first efficacy
data have been presented at the 38th Annual Meeting of the American Society
of Clinical Oncology (ASCO) in May 2002. Further development includes
clinical phases II and III with multiple courses of AP 12009. Antisense Pharma is a biopharmaceutical company located in Regensburg, Germany.
The Company is exploiting its expertise in discovery research and product
development to commercialize innovative antisense therapeutics for the
treatment of cancer.This press release contains forward-looking statements
with respect to Antisense Pharma GmbH’s business. By their nature,
forward-looking statements and forecasts involve risks and uncertainties
because they relate to events and depend on circumstances that will occur
in the future. There are a number of factors that could cause actual results
and developments to differ materially. Antisense Pharma GmbH disclaims
any intent or obligation to update any of these forward-looking statements.
Press Release 2002/06/04
Results From Phase I/II Study For AP 12009 In Malignant Brain Tumors
REGENSBURG, GERMANY- June 04, 2002. Data from the first Phase I/II trial
of Antisense Pharma´s AP 12009 in patients with recurrent high-grade
glioma were presented at the 38th Annual Meeting of the American Society
of Clinical Oncology (ASCO) and report excellent safety and tolerability.
Within a 64fold escalation of the initial dose no dose-limiting side effects
or maximum tolerated dose were observed. The primary endpoint to determine
safety and tolerability was surpassed in that first efficacy data were
also obtained. Thus far, 6 out of 18 patients show a stabilization or
response. The study was conducted by the Departments of Neurology and
Neurosurgery, University of Regensburg, and the Department of Neurosurgery,
University of Kiel.
The clinical Phase I/II study was designed with the primary objective
of determining the maximum tolerated dose in patients with malignant glioma
who had failed other therapies. All patients were treated with a single
course of AP 12009 via an intra-tumoral catheter to bypass the blood brain
barrier. Both operable and inoperable patients had been enrolled. All
of them had received at least one previous chemotherapy, usually temozolamide.
The overall median survival time with AP 12009 following temozolamide
is longer compared to the literature data for temozolamide alone. “Based
on the results seen in this Phase I/II study, we are excited to investigate
AP 12009 in international trials which will utilize the same route and
schedule of administration but will provide multiple cycles of AP 12009
to each patient“ said Dr. Gerhard Stauder, Chief Scientific Officer
at Antisense Pharma. “The Data Safety Monitoring Board (DSMB) confirmed
that the safety profile of the study drug is excellent and no safety concerns
have been reported.“ The DSMB is an independent body of oncologists
and neurologists responsible for evaluating patient safety and ensuring
the integrity of the trial.
High-grade glioma is the most malignant brain tumor in man with more than
50,000 patients in the territories USA, Europe and Japan diagnosed in
the WHO grade III (anaplastic astrocytoma) or grade IV (glioblastoma).
These patients need new treatment options as their survival rates are
poor, and chemotherapy and radiation therapy have significant and often
permanent side effects. Patients with progressive tumor growth have an
impaired immune function. The key way for tumors to escape immune surveillance
is by overexpressing the strongest immunosuppressor known, TGF-beta (transforming
growth factor). High grade gliomas strongly overexpress this factor. AP
12009 is a phosphorothioate antisense oligonucleotide and represents a
selective TGF-beta2 inhibitor. It works by targeting the overexpression
of TGF-beta2 mRNA and blocking the signaling pathways within the cell
that are implicated in the growth and survival of cancer cells. This target
mode of action is different from cytotoxic chemotherapies and small molecule
or peptide protein inhibitors. The key advantages of AP 12009 are reversing
the TGF-beta2 induced immunoblockade, reactivating the immune system to
fight the tumor, and at the same time inhibiting tumor cell growth and
migration. As AP 12009 targets mRNA, it is not expected to induce mutagenesis
resulting in drug resistance. "We are excited about the clinical
data showing not only safety but also efficacy data on AP 12009."
said Dr. Karl Schlingensiepen, Chief Executive Officer at Antisense Pharma.
“This is a great step forward towards bringing this novel compound
to the patients and to thus improve clinical prognosis and quality of
life. The results also strongly endorse our development program for AP
12009 in other solid tumors."
Antisense Pharma GmbH is a German biotech business engaged in the research,
development, and marketing of prescription pharmaceuticals for highly
unmet medical needs. Antisense Pharma is exploiting its unique expertise
in the antisense technology to develop novel human anticancer drugs. This
press release contains forward-looking statements with respect to Antisense
Pharma GmbH’s business. By their nature, forward-looking statements
and forecasts involve risks and uncertainties because they relate to events
and depend on circumstances that will occur in the future. There are a
number of factors that could cause actual results and developments to
differ materially. Antisense Pharma GmbH disclaims any intent or obligation
to update any of these forward-looking statements.
Press Release 2002/04/29
First Clinical Data at ASCO Meeting
REGENSBURG, GERMANY - April 29, 2002. Antisense Pharma GmbH today announced
the presentation of clinical data of AP 12009 in high-grade glioma at
the 2002 Annual Meeting of the American Society of Clinical Oncology (ASCO)
on May 21st in Orlando, Florida. The results will be presented by Dr.
Peter Hau, investigator at the Department of Neurology, University of
Regensburg, Germany: Poster #109
Title TGF-beta2 Antisense Oligonucleotide AP12009 Administered Intratumorally
to Patients with Malignant Glioma in a Clinical Phase I/II Dose Escalation
Study: Safety and Preliminary Efficacy Data
Session Tuesday, May 21, 2002
Poster 12:00 P.M. - 3:00 P.M (Level 2, Hall C)
Discussion 11:00 A.M. - 12:00 P.M (Level 3, 311A) In a preliminary analysis
of a Phase I/II trial of the TGF-beta2 antisense compound AP 12009 as
a single agent using an intratumoral high-flow microperfusion, the clinical
investigators observed excellent safety and tolerability in patients with
high-grade glioma (glioblastoma and anaplastic astrocytoma), surpassing
the primary endpoint of the study.
Eighteen patients, all of whom had relapsed from extensive prior standard
treatment, received AP 12009 in a single course. Within a 64fold escalation
of the initial dose no dose-limiting side-effects were observed thus far.
A descriptive analysis also evaluated patient response. 6/18 patients
receiving AP 12009 in the study achieved an objective response or stabilization
after only a single course. “We are encouraged having observed first
therapeutic effects”, explained the primary investigator of this
study, Professor Ulrich Bogdahn, Department of Neurology, University Regensburg.
“Both excellent tolerability and high patient acceptance together
with first data on efficacy accelerate our development of AP 12009 for
glioma patients”, said Dr. Gerhard Stauder, Chief Scientific Officer
at Antisense Pharma GmbH. “In addition, the recently received Orphan
Drug Designation in the European Union supports our strategy to expand
our clinical trial program to further trials and sites.”
Antisense Pharma GmbH is exploiting its expertise in DNA antisense to
develop novel human therapeutic drugs. AP 12009 is the most advanced in
a portfolio of products.
Press Release 2002/04/15
Antisense Pharma Receives Orphan Drug Status for AP 12009 in High-Grade Glioma
REGENSBURG, GERMANY - April 15, 2002. Antisense Pharma GmbH announced
today that it has received orphan drug designation from the Commission
of the European Communities for AP 12009 in the treatment of high-grade
glioma.
Orphan drug designation can be applied for in the EU if the disease is
life-threatening or debilitating and affects not more than five in 10,000
persons in the European Community, in case that no other satisfactory
method exists or the medicinal product provides significant benefit."We
are pleased to announce the orphan drug status for the European Union,
which accelerates our efforts to rapidly develop and commercialize AP
12009" said Dr. Karl-Hermann Schlingensiepen, Chief Executive Officer
of Antisense Pharma. "High-grade glioma is one of the most aggressive
and devastating cancers. Despite various therapeutic approaches including
surgery, radio- and chemotherapy, the prognosis for the patients remains
poor. We expect AP 12009 to significantly improve the therapeutic outcome
of glioma patients as well as being better tolerated than standard therapy."
AP 12009 is a specific antisense inhibitor of TGF-β2
protein production. TGF-βis the
most potent immunosuppressor known and plays a key role in tumor progression.
Secretion of high levels of TGF-βby
the tumor cells prevents the host immune system from recognizing and destroying
the tumor cells. Inhibition of TGF-β
production with AP 12009 reverts the immunosuppressive effects and enables
the immune system to recognize the tumor cells and to destroy them. "In
ongoing Phase I/II clinical trials in patients with recurrent, inoperable
high-grade gliomas AP 12009 shows excellent local safety and tolerability"
explains Dr. Gerhard Stauder, Chief Scientific Officer of Antisense Pharma.
High-grade glioma is the first indication for which Antisense Pharma clinically
develops AP 12009. In a variety of other cancer types elevated TGF-βplasma levels are correlated with malignancy, invasiveness and
poor clinical prognosis. Thus, Antisense Pharma´s inhibitors of
TGF-β have a great potential
for the treatment of a variety of cancer indications.
Antisense therapy is one of the most promising novel approaches for the
treatment of malignant diseases. It has proven its potential in a number
of clinical trials in recent years showing high efficacy and only few
side effects. Antisense Pharma is a German biotechnology company with
a broad expertise in both antisense technology and oncology. AP 12009
is the most advanced in a portfolio of products.
Press Release 2002/03/11
Phase I/II Data Presented on AP 12009 in Glioma Patients
Regensburg (Germany), 11th March 2002. Phase I/II data on Antisense Pharma’s compound AP 12009 are presented at the 2002 Annual Meeting of the German Cancer Society in Berlin. AP 12009 is currently under investigation for patients with high-grade glioma, the most severe form of brain tumor. In this clinical trial at the University of Regensburg and the University of Kiel AP 12009 is applied intratumorally by high-flow microperfusion. AP 12009 is an Antisense inhibitor of transforming growth factor beta2 (TGF-beta2). TGF-beta2 is a key factor produced by glioma cells. TGF-beta2 suppresses the immune system. It also stimulates tumor cell growth and migration, and supports angiogenesis (the supply of the tumor with blood vessels). AP 12009 is an antisense oligonucleotide that specifically inhibits TGF-beta2 production. High-grade glioma (WHO grades III and IV) is one of the most aggressive tumors known. Despite various therapeutic approaches including surgery, radio- and chemotherapy, the prognosis of patients remains poor. Dr. Gerhard Stauder, Chief Scientific Officer of Antisense Pharma: “In contrast to chemotherapeutics, which act at the limit to non-tolerability, the biologic agent AP 12009 shows a very high tolerability. A 64-fold escalation of the first dose has been well tolerated. Data were evaluated by an independent Data Safety Monitoring Board and no drug related adverse events have been observed. Both, excellent local tolerability and high acute safety, open a broad therapeutic index for administration of AP 12009. The dose-limiting toxicity (DLT) is still not reached. A subsequent Phase I/II clinical trial applying a new port system will allow the enrollment of further patients with an increasing number of courses per patient“. Antisense Pharma GmbH is dedicated to research, development and commercialization of innovative drugs against cancer.
Press Release 2001/10/15
Antisense Pharma licenses Biognostik's Anticancers
Antisense Pharma GmbH obtained the option rights by Biognostik GmbH (Goettingen, Germany) to exclusively develop and market world-wide antisense molecules for the treatment of cancer and other serious diseases. Within the scope of the agreement Antisense Pharma could develop up to four lead molecules for different indications. Biognostik's research efforts center around the early-stage development of therapeutic synthetic nucleic acid sequences (SNAS). The molecules offered to Antisense Pharma have been discovered and validated by Biognostik's proprietary drug design platform .R.A.D.A.R. Antisense oligonucleotides represent a new generation of "informational drugs" targeting the expression of tumor proteins in a causality-based approach. Based on strong pre-clinical and clinical expertise Antisense Pharma has established a proprietary platform for research and development of innovative drugs for unmet medical needs with focus on antisense technology and cancer. Antisense Pharma's lead compound, AP 12009, is in clinical phase I/II for treatment of the most severe brain tumor, malignant glioma. The company is investigating AP 12009 for several oncologic indications and has other antisense products in its pipeline. "With the new validated lead molecules we will move forward in expanding our strong R&D pipeline" says COO Dr Reimar Schlingensiepen. "The recently signed agreement with Biognostik enables us to develop a variety of innovative drugs for tumors like gastrointestinal, gynecological and skin cancer", he adds. With drugs in development addressing some of the most fundamental mechanisms of tumorigenesis, Antisense Pharma is committed to establish international strategic partnerships for joint development and commercialization of these products.
Press Release 2001/06/01
Lead Cancer Compound AP 12009 in Phase I/II
Two years after the company's founding, Antisense Pharma's leading antisense drug for treating brain tumors has been taken to clinical trial. The Regensburg-based German biotech company's core business focuses on the research, development, and commercialisation of biotechnological and pharmaceutical products to fulfil as yet unmet medical needs.
... from Discovery to Market
The novel causality-based approach to the discovery and development of
antisense pharmaceuticals is driven by a unique combination of proprietary
technologies. The company's portfolio covers the complete R&D range
from discovery to market.
Antisense Pharma's drug discovery policy is based on a rationale directed
at the specific indication, application and desired efficacy. "No
more than ten prime oligonucleotides out of tens of thousands of possible
molecules are selectable per target gene. Our ability to select the right
ones is the driver that significantly accelerates the process for identifying
the most effective drug candidates" explains CEO Karl-Hermann Schlingensiepen.
By intervening in the expression of pathological proteins and combining
high efficacy with a low rate of side effects, antisense drugs are able
to conquer diseases at their etiological roots.
... Products
A broad range of products for oncological indications are currently in the preclinical and clinical stages of development. The most advanced compound AP 12009, a TGFβ2-antisense molecule for the treatment of glioblastoma entered phase I/II trials in October 2000. Antisense Pharma is committed to fostering international strategic partnerships for the joint development and commercialization of a variety of drugs at all stages.
... Management and Strategy
The company is run by corporate executives with a strong track record in both scientific accomplishments and entrepreneurial biotechnology. The senior managers are backed by a Scientific Advisory Board and a Data Safety Monitoring Board both composed of prestigious international experts in the fields relevant to the company´s business. This provides the optimal breeding ground for the company's accelerated growth that keeps pace with its continually expanding product portfolio.