CTI Biopharma to submit New Drug Aplication for Pacritinib

CTI Biopharma to submit NDA for Pacritinib

September 23, 2015
CTI BioPharma Corp. today announced their plan to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Pacritinib, an oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. They are requesting approval for this drug as a treatment for patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter (<50,000/uL).


Submission of an NDA after a single Phase 3 trial under accelerated approval, instead of waiting to complete two Phase 3 trials, could potentially reduce time to market by up to 14 months.


Read the full press release from CTI Biopharma here.


For more information about the FDA Accelerated Approval program click here.


The PERSIST-1 trials, which is a randomized trial of Pacritinib against best available therapy in patients with  myelofibrosis regardless of platelet counts is ongoing. CTI Biopharma is working in partneship with Baxalta on the development of Pacrinitib.

- See more at: http://www.mpnresearchfoundation.org/CTI-Biopharma-to-submit-NDA-for-Pacritinib#sthash.Sx6PDYf6.dpuf

What's next for MPN Research?

Before there was knowledge of the JAK2 mutation, there was the MPN Research Foundation.

 

Both the Foundation and MPN patients had the nerve to demand that medical science deal with us now. 

 

We were audacious enough to be impatient, to push for better and more treatment options now. 

 

On a personal level, being diagnosed with an MPN may have been one of the biggest shocks of your life. Globally, the fight against cancer is one of the most significant challenges in history, and we must not rest until we have the answers we deserve, answers that lurk in our bodies and in as-yet untried interventions.  

 

Sixty years after the MPNs were first identified we have finally begun to make progress. One approved medication. There are more treatments in clinical trials now than ever before, all representing a promise of new and better options. These are good things, but it is not enough, and it is not time to sit back and wait. 

 

Now is the time to act. So we are asking you today: what's next? If you could focus MPN research on one problem or area of interest, what would it be? Take a moment to tell us now. We're listening.

Our support means you are never alone.


In the fight against MPN Blood Cancer, Research & Support can make all the difference. The MPN Research Foundation is your partner. The innovative research we fund moves science forward. Support from family, friends and us means you are never alone. Together we can make a difference today, while finding better treatments and a cure for tomorrow. Patients and caregivers have options for support, both online and in person.


The MPN Research Foundation will be rolling out a list of activities for MPN patients to participate in during the month of September and will be highlighting some of the important work currently being conducted in research, advocacy and education. These activities have been spearheaded not just by MPN Research Foundation, but by a wider group of organizations working together to help patients.

Blood Cancer Awareness Month Events

Patient Support Groups

Denver
September 10, 2015
Contact: Mabel at mabel.d.peters@kp.org 303-764-8523

Chicago
September 10, 2015-Gilda's Club Chicago.@6-8pm
Contact: Raquel at rnunez@mpnresearchfoundation.org

Pittsburgh

September 17, 2015
Contact: Jean at 724.831.0368 or Email: mpn.pgh.sup@gmail.com
www.facebook.com/MPN.Pittsburgh.Support


Los Angeles
September 26^th 11am to 3pm.
Contact: Ron Anderson at ron.anderson77@gmail.com

SF Bay Area

October 3rd at 9:30am-4:30pm in San Francisco

Contact:Susanklepper@hotmail.com

Registration required and space is limited.


For patient support group meetings beyond September click here

- See more at: http://www.mpnresearchfoundation.org/MPNBloodCancerAwarenessMonth-5F2013#sthash.MvblxsAY.dpuf

Patient Symposiums

Cancer Support Community

September 1-30 – CSC local sites will be hosting  awareness events: Shining the Light on MPN during the month of September.


Leukemia and Lymphoma Society


Tuesday, September 8, – Blood Cancer Conference in Hershey, Pennsylvania

MPN Advocacy and Education International

September 11-12 - Women and MPN , San Diego, CA

 Patient Power

A Town Meeting for Patients, Their Families & Care Partners

Saturday, September 12, - Online and In-Person in Stanford, CA


Cancer Support  Community of Greater Philadelphia


Saturday, September 12, at 4100 Chamounix Drive, Philadelphia, PA 19131.
Breakfast will be served at 9 a.m. with the lecture starting at 9:45 a.m. Speaker is Dr. Gerald L. Messerschmidt, the director of clinical research at Lankenau Institute for Medical Research.


Leukemia and Lymphoma Society


Saturday, September 19, Blood Cancer Conference in Worcester, Massachusetts


The Canadian MPN Network


Saturday, September 26, Patient advocacy Conference


Leukemia and Lymphoma Society


September 26, Blood Cancer Conference in Chicago, Illinois


MPN Voice


September 30, Patients' Forum, Edinburgh Register Here: http://www.mpdvoice.org.uk/get-involved/lead-a-forum/mpn-voice-patients%E2%80%99-forum-%E2%80%93-edinburgh-2015/

·The Latest News on Research and Treatment for Myeloproliferative Neoplasms (MPNs)

A Town Meeting for Patients, Their Families & Care Partners

Being diagnosed with, a rare medical condition like a myeloproliferative neoplasm (MPN) can be overwhelming and sometimes confusing. The good news is that innovations in the field are increasing the understanding of MPNs. Research advances are making a difference and improving the lives of those living with polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF).

Saturday, September 12, 2015 - Online and In-Person in Stanford, Calif.

·The Latest News on Research and Treatment for Myeloproliferative Neoplasms (MPNs)

A Town Meeting for Patients, Their Families & Care Partners

Being diagnosed with, a rare medical condition like a myeloproliferative neoplasm (MPN) can be overwhelming and sometimes confusing. The good news is that innovations in the field are increasing the understanding of MPNs. Research advances are making a difference and improving the lives of those living with polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF).

Saturday, September 12, 2015 - Online and In-Person in Stanford, Calif.

 

Fundraising Events

 

Tim’s Run

Yarmouth, ME

Sunday, September 27, 2015

http://www.timsrunwalk.com/

 

Chicago Half Marathon

Sunday, September 27, 2015

http://www.firstgiving.com/fundraiser/teresa-luedke/TeresaLuedkesPage 

You can help change your prognosis!

 

As you know, September is Blood Cancer Awareness Month. Last year, 120 MPN patients let us know what research project they felt was important by making a gift during Blood Cancer Awareness Month. After our scientific Review Board reviewed and approved a list of projects, MPN patients family members and friends choose from this list and told us where we should use their gift.

 

These patients directed their funds to support a small pilot study of 10 patients that will investigate a patient’s response to immuno-therapy. 

 

Our immune system, which fights infections, does not inhibit the development of MF. Restoring the ability of our immune system to respond to MF is the goal of this project. The interaction between two proteins known as PD1 and PDL-1 has been widely investigated and is an established approach to restore our immune system to respond to hard tumors and lymphoid cancers. This project will use a drug called a PDL-1 inhibitor that will determine a MF patient’s response to this type of therapy.  If the results of this project is successful, it could lead to the development of a new therapy for MF patients.

 

If you want to help change your prognosis, all you need to do is make a contribution to the MPN Research Foundation in September. Go to: https://www.givedirect.org/give/givefrm.asp?CID=12140. With your gift, you will get to vote for a specific research project approved by our Scientific Review Board during our next funding cycle.

 

The project with the most votes, will be designated the BCAM Research Project for 2016.