Bli medlem
Bli medlem

Du är här

2016-05-31

Oncology Venture: OV LiPlaCis™ - First Screened Breast Cancer Patient Dosed in First Prospective Study

Hoersholm, Denmark; May 31st, 2016 - Oncology Venture Sweden AB
(OV:ST) announces that the first patient has been dosed in the proof
of concept extension phase of the dose escalation phase 1 study with
LiPlaCis. LiPlaCis has already in the dose escalation part shown
promising clinical activity in unselected, hard to treat patients.
LiPlaCis is the lead product in Oncology Ventures pipeline, and this
is the first prospective trial using the Drug Response Predictor,
DRP™.

Twelve to fifteen (12-15) screened patients with metastatic Breast
Cancer (mBC) are now to be enrolled in the LiPlaCis extension phase
of the study to demonstrate safety and efficacy.

Using DRP-analysis of biopsies - patients are screened beforehand for
high likelihood of effect of the LiPlaCis™ drug. The DRP™ should
thereby enable a high response rate and give breast cancer patients a
new effective personalized treatment opportunity.

The extension PoC phase will take approximately 12 months, with
interim data expected during this period.

More than 1000 patients have had their tumors DRP-screened beforehand.
The included patients in the LiPlaCis proof of concept study will be
in the top 10% of high likely responders according to the DRP™, by
which patients' individual biopsies are analyzed for sensitivity
(effect) to LiPlaCis. Using a conservative cut off of top 10% is to
demonstrate the ability of the DRP™ to select sensitive patients.
Later, the cut off is expected to be less conservative, as the
relevant patient population is expected to be at a cut off around
30-40%.

"I am very excited that our lead product LiPlaCis is now including
Breast Cancer patients in this first prospective study. This is a
major step ahead for Oncology Venture. The LiPlaCis extension study
is set up to demonstrate that our DRP™ can select those patients who
will benefit from the treatment ", said Adjunct Professor Peter Buhl
Jensen, MD, PhD and CEO of Oncology Venture. "The hope is that we can
develop a new, effective personalized treatment option for Breast
Cancer patients with metastatic disease. We believe the future lies
in personalized treatment, and that Oncology Venture is at the
forefront with its DRP technology", Dr. Buhl Jensen further
commented.

About LiPlaCis

Cisplatin is one of the most widely used drugs in the treatment of
cancer due to its documented efficacy in a number of tumour types.
Cisplatin is used in the treatment of large indications such as Lung
Cancer (EU+US ? 480,000 new cases annually), Head and Neck Cancer
(500,000 cases annually worldwide) Bladder Cancer (EU+US ? 170,000
annually) and Ovarian Cancer (EU+US ? 71,000 annually). The lipid
formulation LiPlaCis is the answer to a well-established need for
improving cisplatin therapy and the formulation of the drug, so that
a more selective up-take of cisplatin takes place at the site of the
tumor.

More About LiPlaCis™ and the Clinical Testing

The Phase 1 study to evaluate the safety and tolerability of LiPlaCis
in patients with advanced tumours has been conducted at a Phase 1
Unit at a University Hospital in Copenhagen and has included 20
patients in the dose escalation part of a phase 1 study in solid
tumors. The LiPlaCis program has now moved into the extension proof
of concept phase, which is part of the phase 1 application where
patients with a specific disease - here metastatic Breast Cancer -
are included to investigate early Proof of Concept, i.e. effect of
the drug. 75mg LiPlaCis™/patient is administered intravenously in
weekly cycles on day 1 and day 8. Upon the investigator's judgement,
the patient may continue treatment for more than three cycles when
benefiting from the study drug.

About the Drug Response Predictor - DRP™ - Screening Tool

Oncology Venture uses the MPI DRP™ to select those patients that by
the gene signature in their cancer is found to have a high likelihood
of response to the drug. The goal is to develop the drug for the
right patients and by screening patients before treatment the
response rate can be significantly increased.

This DRP™ method builds on the comparison of sensitive vs. resistant
human cancer cell lines including genomic information from cell lines
combined with clinical tumor biology and clinical correlates in a
systems biology network. The DRP™ based on microRNA is used on
certain products where the DRP™ based on messenger RNA is more
broadly useable and more validated.

For further information, please contact

CEO Peter Buhl Jensen, Adjunct professor, MD, PhD Ulla Hald Buhl, COO, IR & Communication

Telephone: +45 21 60 89 22 Telephone +45 21 70 10 49

E-mail: pbj@oncologyventure.com E-mail: uhb@oncologyventure.com

About Oncology Venture Sweden AB

Oncology Venture Sweden AB is engaged in the research and development
of anti-cancer drugs via its wholly owned Danish subsidiary Oncology
Venture ApS. Oncology Venture has a license to use Drug Response
Prediction - DRP™ - in order to significantly increase the
probability of success in clinical trials. DRP™ has proven its
ability to provide a statistically significant prediction of clinical
outcomes from drug treatment in cancer patients in 29 of the 37
clinical studies that were examined. The Company uses a model that
alters the odds in comparison with traditional pharmaceutical
development. Instead of treating all patients with a particular type
of cancer, patients are screened first and only those who are most
likely to respond to the treatment will be treated. Via a more
well-defined patient group, the risk and costs are reduced while the
development process becomes more efficient.

The current product portfolio: LiPlaCis™, for Breast Cancer,
Irofulven, developed from a fungus, for Prostate Cancer, and APO010,
an immuno-oncology product for Multiple Myeloma.

-----------------------------------------------------------
http://news.cision.com/oncology-venture/r/ov-liplacis----first-screened-...
http://mb.cision.com/Main/12685/2020524/522901.pdf

Författare ATORG

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.