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Old 06-17-2008, 05:56 AM   #1
eric
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Phase I/II Clinical Trial of AXl1717

http://www.therapeuticsdaily.com/new...e&channelID=29
Axelar Initiates Phase I/II Clinical Trial on Cancer Patients With the New Anti-Cancer Drug AXl1717

STOCKHOLM, June 17 /PRNewswire/ -- Axelar AB today announced that the company recently has initiated a phase I/II clinical trial on cancer patients with its new anti-cancer drug AXL1717, an insulin-like growth factor-1 (IGF-1) receptor inhibitor. The phase I/II clinical trial is primarily designed to assess the safety, tolerability, and pharmacokinetics of the drug. As a secondary objective, anti-cancer effects will be documented whenever possible and the study will be conducted in Sweden.

The preclinical research conducted on AXL1717 demonstrated favorable characteristics in potency, tolerability and pharmacokinetic properties, supporting the exploration of oral dosing in clinical trials.

"Since there exists a significant unmet need for new and effective treatments of cancer, we are extremely pleased that this project has now entered clinical trials," says Johan Harmenberg, CEO of Axelar AB. "Targeting cancer cells with AXL1717 instead of conventional cytotoxic chemotherapy is a new and exciting treatment alternative."

About Cancer, the IGF-1 receptor and AXL1717

Globally more than 12 million people are diagnosed with cancer every year. Cancer is causing the death of about 8 million people per year. Although a number of cancer drugs successfully have been launched over the last decade, many cancers still lack an effective therapy. This, together with the fact that many treatments still result in severe side effects, highlight the strong medical need for new and alternative anti-cancer therapies.

The IGF-1 receptor is a promising target for the treatment of cancer, since the receptor is crucial for the survival and growth of malignant cells. In contrast, the IGF-1 receptor is not necessary for growth of normal cells.

AXL1717 is a targeted small-molecule IGF-1 receptor inhibitor with no effect on the important and almost identical insulin receptor. AXL1717 may therefore provide a new treatment option for patients with incurable cancer. Pre-clinical data show an extraordinary anti-tumor efficacy, including tumor extermination, in animal models for a wide range of human cancers such as breast and prostate cancers, malignant melanoma, multiple myeloma, glioblastoma and sarcoma. In addition, AXL1717 has shown a favorable preclinical tolerability profile and the medication is given orally.

About Axelar AB

Axelar AB is a Swedish biotech company that was founded in 2003 by Professor Magnus Axelson, Professor Olle Larsson and Karolinska Innovations AB. The company focuses its activities on research related to IGF-1 receptor inhibitors and their applications in important human diseases such as cancer, psoriasis, atherosclerosis, restenosis after angioplasty, and macula degeneration.

Visit http://www.axelar.se.
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Old 06-17-2008, 01:34 PM   #2
lilyecuadorian
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Location: CHARLOTTE NC USA Home town (ECUADOR) South America
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thanks Eric !!!
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Diag April/06 5 months after give birth my son Max
stage IV mets on liver (5 tumors) 38 year old,
her2+++ and ER+PR+ from32 nodes 4 positives
mastectomy right breast chemo before surgery herceptin/carboplatin/taxotere ,clear and surgery have radiation 20, `& then herceptin and tamoxifen
NED until Aug/07 body only then 'n June 04-06-07 .1 lesion of 1.6 cm on cerebellum ...novalis ,open sugery
5m.m brain met again novalis, 4mm.In the liver. Waiting 2 months now 3 tumors enroll on T-MCC trial start first infusion Nov 5/07 at Dec 17 scan show one tumor despair the 2nd and 3th diminish Doc said great results until March/08 ct scan show progression
03-05-08 start tykerb & xeloda
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Old 06-17-2008, 06:20 PM   #3
chrisy
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OOOOh.

This is really interesting - potentially blocking yet another mechanism of resistance! Thanks for posting this, Eric.
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June 2002 extensive hi grade DCIS (pre-cancer-stage 0, clean sentinal node) Mastectomy/implant - no chemo, rads. "cured?"
9/2004 Diag: Stage IV extensive liver mets (!) ER/PR- Her2+++
10/04-3/05 Weekly Taxol/Carboplatin/Herceptin , complete response!
04/05 - 4/07 Herception every 3 wks, Continue NED
04/07 - recurrence to liver - 2 spots, starting tykerb/avastin trial
06/07 8/07 10/07 Scans show stable, continue on Tykerb/Avastin
01/08 Progression in liver
02/08 Begin (TDM1) trial
08/08 NED! It's Working! Continue on TDM1
02/09 Continue NED
02/10 Continue NED. 5/10 9/10 Scans NED 10/10 Scans NED
12/10 Scans not clear....4/11 Scans suggest progression 6/11 progression confirmed in liver
07/11 - 11/11 Herceptin/Xeloda -not working:(
12/11 Begin MM302 Phase I trial - bust:(
03/12 3rd times the charm? AKT trial

5/12 Scan shows reduction! 7/12 More reduction!!!!
8/12 Whoops...progression...trying for Perjeta/Herceptin (plus some more nasty chemo!)
9/12 Start Perjeta/Herceptin, chemo on hold due to infection/wound in leg, added on cycle 2 &3
11/12 Poops! progression in liver, Stop Perjeta/Taxo/Herc
11/12 Navelbine/Herce[ptin - try for a 3 cycles, no go.
2/13 Gemzar/Carbo/Herceptin - no go.
3/13 TACE procedure
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Old 06-19-2008, 12:28 AM   #4
jones7676
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Location: I live in Christmas, MI - located on the shores of Lake Superior.
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Thanks for the post Eric. Looks promising.
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10/03 Radical Mastectomy 3 cm tumor - 1/17 Nodes Stage II B, Her 2 +++ ER-/PR- 11/03 4 AC 4 Taxol 12/05 Stage IV - Lung met , Bone mets - Carbo, Taxotere, Herceptin 9/06 - 2 cm brain tumor 10/06 - Tumor removal surgery - Herceptin Halted 12/06 gamma knife tumor base.1/07 Navelbine/Herceptin 4/07 Rads to R femur 5/07 Stereotactic - new 2 cm brain tumor 4/07 Start Xeloda 5/07 Tykerb added 7/07 Brain MRI clean 10/07 .055 cm brain met found. 12/07 Stereotactic -1 cm brain tumor Start Tykerb 11/07 Abraxane/Herceptin 5/08 Cisplatin, Gemcitabine/Herceptin 6/08 Stereotactic to 1cm 9/08 Stereotactic repeat (growth). 11/08 Pet Scan Good but new tiny met on L lung/dead Brain surgery (no cancer cells found/scar tissue) 1/09 Chemo restarted 2/09 Pet Scan Bad - R larger very active/active L active lymph nodes both sides of chest MRI- mets slight increase 2/09 Start Doxil/Tykerb Treatment
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