Immune System Therapeutics (IST) - it was formerly called Pac-Mab.
Immune System Therapeutics Ltd., a biotechnology company, engages in the development and commercialization of monoclonal antibodies to treat human blood cancers and auto-immune diseases. Its products include MDX-1097, a disease-modifying antibody therapy for hematological malignancies that targets a B-cell surface antigen, which is specific to malignant cells; and IST-1458, a human antibody candidate that binds to LMA for the treatment of B-cell lymphoproliferative diseases. Immune System Therapeutics Ltd. was formerly known as PacMab Ltd. and changed its name in June 2007. The company was incorporated in 2001 and is based in Sydney, Australia.
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greg matthews - Name: Greg Matthews
- Who do you know with myeloma?: myself
- When were you/they diagnosed?: 12-28-2010
- Age at diagnosis: 48
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greg matthews - Name: Greg Matthews
- Who do you know with myeloma?: myself
- When were you/they diagnosed?: 12-28-2010
- Age at diagnosis: 48
Re: Question is this being use in trials in the US
From Myeloma Beacon:
"MDX-1097 Receives Orphan Drug Status For Multiple Myeloma – The Australian bio-therapeutic company Immune System Therapeutics announced last week that it has received orphan drug designation from the United States Food and Drug Administration (FDA) for its investigational drug MDX-1097. MDX-1097 is an antibody that binds to certain proteins on the surface of myeloma cells, triggering the immune system to kill the cancer cells. The FDA uses the orphan drug designation to promote the development of new treatments for rare diseases that affect fewer than 200,000 individuals in the United States. The orphan drug status provides the developer of the drug with multiple benefits, including funding for clinical trials, accelerated FDA approval, and marketing exclusivity for up to seven years. For more information, please see the Immune System Therapeutics press release."
https://myelomabeacon.org/news/2011/07/04/beacon-newsflashes-july-4-2011/
Jan 2012 ...According to Andrew Spencer,
"Professor Spencer said he was in the early stages of developing a large, international phase III trial of the drug. In the trial, patients will be treated with MDX-1097 in combination with
other therapies.
“It’s possible that in the current phase II trial people will show evidence of a favourable response or go into remission, and that’ll be great. However, I believe we will see the most benefit from MDX-1097 in the next round of trials when we combine it with other drugs,” said Professor Spencer.....
It (FDA Orphan status) also provided ITS with multiple benefits including
funding for clinical trials, accelerated FDA approval, and marketing exclusivity for up to seven years.
If you would like more information regarding this trial, please contact Kate Reed, Trial Co-ordinator, on (03) 9076 3571 or Professor Andrew Spencer at aspencer@netspace.net.au. Alternatively, speak with your doctor to determine if you may be suitable and if appropriate, organise a referral to see Associate Professor Andrew Spencer at The Alfred.
http://www.evaluatepharma.com/Universal/View.aspx?type=Entity&entityType=Product&id=38336&lType=modData&componentID=1002#&&_ViewArgs=%7b%22_EntityType%22%3a0%2c%22_Parameters%22%3a%7b%22_ContextData%22%3a%22%7b%5c%22isEPVantage%5c%22%3afalse%2c%5c%22percentage%5c%22%3a-1%2c%5c%22searchWords%5c%22%3a%5c%22%5c%22%2c%5c%22sectionID%5c%22%3a%5c%22%5c%22%2c%5c%22storyID%5c%22%3a%5c%22272758%5c%22%2c%5c%22notSub%5c%22%3afalse%7d%22%7d%2c%22_Type%22%3a1%7d
"MDX-1097 Receives Orphan Drug Status For Multiple Myeloma – The Australian bio-therapeutic company Immune System Therapeutics announced last week that it has received orphan drug designation from the United States Food and Drug Administration (FDA) for its investigational drug MDX-1097. MDX-1097 is an antibody that binds to certain proteins on the surface of myeloma cells, triggering the immune system to kill the cancer cells. The FDA uses the orphan drug designation to promote the development of new treatments for rare diseases that affect fewer than 200,000 individuals in the United States. The orphan drug status provides the developer of the drug with multiple benefits, including funding for clinical trials, accelerated FDA approval, and marketing exclusivity for up to seven years. For more information, please see the Immune System Therapeutics press release."
https://myelomabeacon.org/news/2011/07/04/beacon-newsflashes-july-4-2011/
Jan 2012 ...According to Andrew Spencer,
"Professor Spencer said he was in the early stages of developing a large, international phase III trial of the drug. In the trial, patients will be treated with MDX-1097 in combination with
other therapies.
“It’s possible that in the current phase II trial people will show evidence of a favourable response or go into remission, and that’ll be great. However, I believe we will see the most benefit from MDX-1097 in the next round of trials when we combine it with other drugs,” said Professor Spencer.....
It (FDA Orphan status) also provided ITS with multiple benefits including
funding for clinical trials, accelerated FDA approval, and marketing exclusivity for up to seven years.
If you would like more information regarding this trial, please contact Kate Reed, Trial Co-ordinator, on (03) 9076 3571 or Professor Andrew Spencer at aspencer@netspace.net.au. Alternatively, speak with your doctor to determine if you may be suitable and if appropriate, organise a referral to see Associate Professor Andrew Spencer at The Alfred.
http://www.evaluatepharma.com/Universal/View.aspx?type=Entity&entityType=Product&id=38336&lType=modData&componentID=1002#&&_ViewArgs=%7b%22_EntityType%22%3a0%2c%22_Parameters%22%3a%7b%22_ContextData%22%3a%22%7b%5c%22isEPVantage%5c%22%3afalse%2c%5c%22percentage%5c%22%3a-1%2c%5c%22searchWords%5c%22%3a%5c%22%5c%22%2c%5c%22sectionID%5c%22%3a%5c%22%5c%22%2c%5c%22storyID%5c%22%3a%5c%22272758%5c%22%2c%5c%22notSub%5c%22%3afalse%7d%22%7d%2c%22_Type%22%3a1%7d
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suzierose - Name: suzierose
- When were you/they diagnosed?: 2 sept 2011
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