Iomab-B program/trials

[bailie]

Does anyone have experience or knowledge of these trials? This seems to hold great promise and is ready for Phase III.

http://www.actiniumpharmaceuticals.c...20Dec_2013.pdf

http://actiniumpharmaceuticals.com/lomabB.html

[Neil Cuadra]

Here's what I learned from reading about this drug.

Iomab-B, used in the preconditioning for a stem cell transplant, is a combination of BC8 (a monoclonal antibody developed at the Fred Hutchinson Cancer Research Center) and iodine 131. It targets the CD45 white cell antigen.

The Iomab-B Phase 1 and Phase 2 trial results looked very promising, with 100% of the leukemia and MDS patients in remission 6 months after transplant.

The drug is not specific to MDS, and a lot of the data about it relates to leukemia, but the mechanism is the same in either case. Actinium Pharmaceuticals wants the drug to be approved for MDS, not just leukemia.

They plan a multi-center Phase 3 trial but I'm unclear what the recruiting criteria will be, particularly which bone marrow failure diseases will be included. They are looking for a relatively quick path to FDA approval, but I don't yet see the trial listed at clinicaltrials.gov.

[bailie]

To Phase III

http://finance.yahoo.com/news/actini...JmMQR2dG lkAw

Actinium Pharmaceuticals, Inc. (ATNM.OB) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the Company entered into a manufacturing supply agreement with Goodwin Biotechnology, Inc. (“Goodwin”). According to the agreement, Goodwin will oversee the current Good Manufacturing Practices (cGMP) production of a monoclonal antibody anticipated to be used in an upcoming phase 3 clinical trial of Iomab™-B. Iomab™-B will be used in preparing patients for hematopoietic stem cell transplant (HSCT), commonly referred to as bone marrow transplant (BMT).
“This agreement with Goodwin represents a major risk mitigation step in conducting our phase 3 trial of Iomab™-B,” said Kaushik J. Dave, President and CEO of Actinium. “Goodwin has significant experience in working with companies like ours and the capabilities to provide the scale-up needed for a late-stage clinical trial. Goodwin’s competencies in process and product implementation, quality assurance, and GMP manufacturing make it ideally suited as a manufacturing partner for Actinium as we look forward to launching this pivotal phase 3 trial later this year.”
“We are very excited to be working with Actinium on Iomab™-B, their lead product candidate,” said Karl Pinto, CEO of Goodwin. “Actinium’s cutting edge proprietary platform is able to target different types of cancers that are without any approved treatment options. We look forward to a long-term partnership with Actinium, not only on Iomab™-B, but hopefully also on other products in their pipeline such as Actimab-A.”

About Iomab™-B
Iomab™-B will be used in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant which is the fastest growing hospital procedure in the U.S. The Company established an agreement with the FDA that the path to a Biologics License Application (BLA) submission will include a single, pivotal Phase 3 clinical study if it is successful. The trial population in this two arm, randomized, controlled, multicenter trial will be refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55. The trial size was set at 150 patients with 75 patients per arm. The study design of the pivotal trial is based on results of an earlier Phase 1/2 trial in which sixty percent of the older patients with refractory and relapsed AML exhibited disease free survival estimated at six months. The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting at least 6 months. There are currently no treatments approved by the FDA for AML in this patient population and there is no defined standard of care. Iomab™-B has completed several physician sponsored clinical trials examining its potential as a conditioning regimen prior to a bone marrow transplant in various blood cancers including the Phase 1/2 study in relapsed and/or refractory AML patients. The results of these studies in over 300 patients have demonstrated the potential of Iomab™-B to create a new treatment paradigm for bone marrow transplants by: expanding the pool to ineligible patients who do not have any viable treatment options currently; enabling a shorter and safer preparatory interval for HSCT; reducing post-transplant complications; and showing a clear survival benefit including curative potential.
Iomab™-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine 131 radioisotope. BC8 has been developed by Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues.

[sbk007]

Interesting to see this:
hematopoietic stem cell transplant, commonly referred to as bone marrow transplant which is the fastest growing hospital procedure in the U.S.

I guess their getting better at it or more people are able to get them but either way the more they do the more they learn.

[Relentless Against SAA]

Originally Posted by sbk007

Interesting to see this:
hematopoietic stem cell transplant, commonly referred to as bone marrow transplant which is the fastest growing hospital procedure in the U.S.

I also was surprised to see that BMT is the fastest growing procedure in the US. Thanks for the info.