Some of you may have already seen this news today, but just in case ...
http://www.reuters.com/article/2012/04/02/us-keryxbiopharmaceuticals-idUSBRE8310E620120402
The article is about perifosine, which has been under development as a potential new treatment for myeloma.
Perifosie also has been going through clinical trials for colon cancer. The news that came out today is that the drug was not successful in a large clinical trial testing it in colon cancer.
The article goes on to note:
> "No announcement was made regarding the future of the multiple myeloma study,
> but in our view, we expect the study will be terminated," Bloom Burton & Co analyst
> Philippa Flint said in a note to clients.
>
> Keryx said recruitment for the multiple myeloma study could become increasingly
> difficult given the negative outcome of the colorectal cancer study.
>
> "We will evaluate whether our Phase 3 study of perifosine in relapsed/refractory
> multiple myeloma will continue as planned," Keryx's Chief Executive Ron Bentsur
> said in a statement.
Have any other investment analysts said whether they think the perifosine trial in myeloma will continue or not.
[Moderator's note: Here are the Beacon's news articles related to perifosine: https://myelomabeacon.org/tag/perifosine .]
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Re: Perifosine trial in myeloma may be ditched
Sorry to hear that news Terry! It seemed that perifosine was doing alright in the Myeloma trials, if not in it's other one with colon cancer. The company, Keryx, has taken a real financial hit over this too. I wonder what would happen next ?
-
Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: Perifosine trial in myeloma may be ditched
Hey Terry,
Just saw this publication from Ken Anderson on perifosine in multiple myeloma:
"In multiple myeloma, Phase I/II clinical trials have established the optimal dosing schedule for perifosine and bortezomib in combination, and demonstrated that perifosine can sensitize to, or overcome resistance to, bortezomib, associated with prolonged responses and a favorable side effect profile. Ultimately, the favorable tolerability of perifosine will allow for its testing in combination with multiple targeted therapies to improve PFS and OS, which represent an important unmet need in these populations."
http://www.researchgate.net/publication/224707341_Perifosine__an_oral_anti-cancer_agent_and_inhibitor_of_the_Akt_pathway_mechanistic_actions_pharmacodynamics_pharmacokinetics_and_clinical_activity?ch=reg&cp=re109_x_p2&pli=1&login=ceceaug2%40msn.com
Perhaps, someone needs to give Anderson a call and find out if the trial for multiple myeloma is ongoing.
Just saw this publication from Ken Anderson on perifosine in multiple myeloma:
"In multiple myeloma, Phase I/II clinical trials have established the optimal dosing schedule for perifosine and bortezomib in combination, and demonstrated that perifosine can sensitize to, or overcome resistance to, bortezomib, associated with prolonged responses and a favorable side effect profile. Ultimately, the favorable tolerability of perifosine will allow for its testing in combination with multiple targeted therapies to improve PFS and OS, which represent an important unmet need in these populations."
http://www.researchgate.net/publication/224707341_Perifosine__an_oral_anti-cancer_agent_and_inhibitor_of_the_Akt_pathway_mechanistic_actions_pharmacodynamics_pharmacokinetics_and_clinical_activity?ch=reg&cp=re109_x_p2&pli=1&login=ceceaug2%40msn.com
Perhaps, someone needs to give Anderson a call and find out if the trial for multiple myeloma is ongoing.
-
suzierose - Name: suzierose
- When were you/they diagnosed?: 2 sept 2011
Re: Perifosine trial in myeloma may be ditched
There is some good news regarding perifosine ... It was announced this morning that development of the drug as a potential myeloma treatment will continue. Here is the press release:
May 7, 2012, 7:30 a.m. EDT
Aeterna Zentaris Regains North American Rights for Perifosine from Keryx
QUEBEC CITY, May 7, 2012 -- Aeterna Zentaris to continue ongoing Phase 3 trial in multiple myeloma
Aeterna Zentaris Inc. (the "Company") today announced that it and Keryx Biopharmaceuticals, Inc. ("Keryx") have agreed to terminate their license agreement with respect to perifosine, as a result of which Aeterna Zentaris has regained in full the North American rights to its Akt inhibitor anticancer compound, perifosine, in all indications. The Company also announced that it will continue the ongoing Phase 3 trial in multiple myeloma with this compound. Termination of the agreement was effective as of May 4, 2012.
Under the terms of the agreement to terminate, all intellectual property and development data, including orphan drug designations and Investigational New Drug ("INDs") applications on perifosine generated by Keryx, have been transferred to Aeterna Zentaris. In return, the Company has agreed to pay low single-digit royalties to Keryx on future net sales of perifosine in North America (U.S., Canada and Mexico).
Juergen Engel, PhD, Aeterna Zentaris President and CEO stated, "Our decision to continue the Phase 3 trial in multiple myeloma is based first and foremost on the existing solid preclinical and clinical data, and on the support for this drug among key opinion leaders in this field. Additionally, we believe that market opportunity, examples of other drugs enjoying success after facing setbacks, as well as the reasonable investment required to move forward with this study up to the predefined interim analysis, also make this a sound decision for the Company. Perifosine in multiple myeloma remains a key component of our deep pipeline focused on providing novel, targeted treatment options for cancer patients facing unmet medical needs."
Paul Richardson, MD, Clinical Director of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute commented, "On behalf of my colleagues involved worldwide in the ongoing pivotal trial comparing bortezomib and dexamethasone alone to the same combination with perifosine in the treatment of relapsed, refractory multiple myeloma, I am truly delighted with Aeterna Zentaris' decision to continue this key Phase 3 study. We believe there is a strong rationale for the use of perifosine as part of combination therapy in multiple myeloma, both pre-clinically and clinically. The promise of perifosine as an effective therapeutic agent given the size, strength and maturity of the phase 2 results to date is very considerable, and clearly warrants further study."
About the Phase 3 trial in multiple myeloma
The ongoing Phase 3 trial conducted under a Special Protocol Assessment, is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine to placebo when combined with bortezomib (Velcade®) and dexamethasone in approximately 400 patients with relapsed or relapsed/refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response-rate, overall survival and safety. Two interim analyses have been pre-defined for the study. Approximately 265 events (defined as disease progression or death) will trigger the un-blinding of the data.
May 7, 2012, 7:30 a.m. EDT
Aeterna Zentaris Regains North American Rights for Perifosine from Keryx
QUEBEC CITY, May 7, 2012 -- Aeterna Zentaris to continue ongoing Phase 3 trial in multiple myeloma
Aeterna Zentaris Inc. (the "Company") today announced that it and Keryx Biopharmaceuticals, Inc. ("Keryx") have agreed to terminate their license agreement with respect to perifosine, as a result of which Aeterna Zentaris has regained in full the North American rights to its Akt inhibitor anticancer compound, perifosine, in all indications. The Company also announced that it will continue the ongoing Phase 3 trial in multiple myeloma with this compound. Termination of the agreement was effective as of May 4, 2012.
Under the terms of the agreement to terminate, all intellectual property and development data, including orphan drug designations and Investigational New Drug ("INDs") applications on perifosine generated by Keryx, have been transferred to Aeterna Zentaris. In return, the Company has agreed to pay low single-digit royalties to Keryx on future net sales of perifosine in North America (U.S., Canada and Mexico).
Juergen Engel, PhD, Aeterna Zentaris President and CEO stated, "Our decision to continue the Phase 3 trial in multiple myeloma is based first and foremost on the existing solid preclinical and clinical data, and on the support for this drug among key opinion leaders in this field. Additionally, we believe that market opportunity, examples of other drugs enjoying success after facing setbacks, as well as the reasonable investment required to move forward with this study up to the predefined interim analysis, also make this a sound decision for the Company. Perifosine in multiple myeloma remains a key component of our deep pipeline focused on providing novel, targeted treatment options for cancer patients facing unmet medical needs."
Paul Richardson, MD, Clinical Director of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute commented, "On behalf of my colleagues involved worldwide in the ongoing pivotal trial comparing bortezomib and dexamethasone alone to the same combination with perifosine in the treatment of relapsed, refractory multiple myeloma, I am truly delighted with Aeterna Zentaris' decision to continue this key Phase 3 study. We believe there is a strong rationale for the use of perifosine as part of combination therapy in multiple myeloma, both pre-clinically and clinically. The promise of perifosine as an effective therapeutic agent given the size, strength and maturity of the phase 2 results to date is very considerable, and clearly warrants further study."
About the Phase 3 trial in multiple myeloma
The ongoing Phase 3 trial conducted under a Special Protocol Assessment, is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine to placebo when combined with bortezomib (Velcade®) and dexamethasone in approximately 400 patients with relapsed or relapsed/refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response-rate, overall survival and safety. Two interim analyses have been pre-defined for the study. Approximately 265 events (defined as disease progression or death) will trigger the un-blinding of the data.
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