Hi to all,

As most here know CH and Migraine a common therapeutic target - CGRP release. To all those (like me) who had their heart broken when CGRP receptor antagonist medications fell over. I'm sure the significance of this will not be lost on CHers. "Spill over" from Migraine research means that in my town I may get a "shot" at this, through the right ethical and appropriate use channels, of course. The promise of a once a month vaccination against CGRP release gives me much hope.

Enjoy!

Cheers, Ben.

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Alder BioPharmaceuticals Inc. Initiates Phase 1 Clinical Study of Antibody Therapeutic Candidate for Treatment of Migraine, ALD403

Therapeutic Targets Well-Validated Biology through Inhibition of Calcitonin Gene-Related Peptide (CGRP)

BOTHELL, Wash., May 7, 2012 /PRNewswire/ -- Alder BioPharmaceuticals Inc. today announced the initiation of a Phase 1 clinical study of its antibody therapeutic candidate, ALD403, targeting the calcitonin gene-related peptide (CGRP) for treatment of migraine.

The placebo-controlled, single ascending-dose study will evaluate the safety and tolerability of ALD403 administered via both intravenous infusion and subcutaneous injection.

Healthy volunteers will be enrolled in the study and followed for 12 weeks following the treatment. In addition to the primary endpoints of safety and tolerability of the two formulations of ALD403, the study will also evaluate the pharmacokinetic and pharmacodynamic profiles of the treatment in the healthy volunteers.

"There is a significant need in patients who experience migraines on a routine basis to have a convenient treatment that can prevent the migraine before it starts," said Randall Schatzman , Ph.D., president and chief executive officer of Alder BioPharmaceuticals. "We see distinct promise in ALD403 to meet this need given its potency and specificity for CGRP, which has been established as a validated target in migraine. ALD403 is manufactured with our Mab Xpress technology which allows us to mass produce the antibody for large markets, such as migraine and to rapidly achieve proof of concept.

Research has shown that CGRP has a role as a trigger for migraine attacks, and inhibiting the peptide has demonstrated promise in preventing the onset of migraines. ALD403 is expected to be developed for patients experiencing multiple migraines per month with self-administered infrequent dosing.

Alder's core technology enables the production of antibodies in very high quantities with improved cost structure via their Mab Xpress technology, allowing this class of therapeutics to enter disease areas that have previously been inaccessible for antibodies, such as migraine and cardiovascular disease. Proof of concept for this technology was achieved with ALD518, a monoclonal antibody to the pro-inflammatory cytokine IL-6, which is currently under Phase 2 development by Bristol-Myers Squibb for autoimmune diseases (BMS-945429), while Alder is developing the antibody for cancer-related conditions.

About Alder BioPharmaceuticals

Alder BioPharmaceuticals Inc. uniquely identifies, develops and manufactures novel antibody therapeutics to alleviate human suffering in cancer, pain, cardiovascular and autoimmune and inflammatory disease areas. The company's investigational monoclonal antibody for migraine, ALD403, inhibits a well-validated molecule shown to trigger migraine attacks, calcitonin gene-related peptide (CGRP), and is now in clinical trials. ALD518 is Alder's investigational monoclonal antibody to the pro-inflammatory cytokine IL-6. Alder is developing ALD518 in Phase 2 clinical studies in multiple cancer-related conditions, while Bristol-Myers Squibb is investigating the asset (as BMS-945429) in a Phase 2b clinical study in rheumatoid arthritis and other autoimmune indications based on a 2009 partnership.

Alder's management team combines decades of industry experience with a proven track record for identifying and developing novel antibody therapeutics and enabling partners through the out-licensing of its technologies. For more information, visit Multimedia File Viewing and Clickable Links are available for Registered Members only!!  You need to or .

Alderbio's page on CGRP antibody in Migraine:
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First Patients Dosed in Proof-of-Concept Clinical Study of Alder Biopharmaceuticals’ Lead Therapeutic Candidate for Treatment of Migraine, ALD403
March 20, 2013

Company that Discovered and Developed Clazakizumab, Previously Known as ALD518, Advances New Program into Phase 2 Study

BOTHELL, Wash., March 20, 2013 /PRNewswire/ — Alder Biopharmaceuticals Inc. today announced the dosing of the first patients in a proof-of-concept Phase 2 clinical study of its antibody therapeutic candidate, ALD403, targeting calcitonin gene-related peptide (CGRP) for treatment of migraine.

The double-blind, placebo-controlled, randomized study will evaluate the safety and efficacy of ALD403 administered monthly. One hundred and sixty patients with frequent, episodic migraines will be enrolled in the study across six sites for six months. Patients in the study will have experienced between four and 14 migraines per month in at least three months prior to enrollment and take acute migraine medication.

“Despite the enormous progress made in acute treatments for migraine, substantial unmet needs remain for patients experiencing multiple migraines per month,” said Richard Lipton, M.D., principal investigator, professor of neurology and epidemiology at Albert Einstein College of Medicine in Bronx, New York, and director of the Montefiore Headache Center. “Most currently available preventive treatments for migraine are taken on a daily basis, reduce migraine frequency by 50 percent in about half of users and often produce significant side effects. A biologic targeting CGRP and offering higher rates of efficacy, along with less frequent dosing and fewer side effects, could have a tremendous benefit for patients.”

Added Randall Schatzman, Ph.D., president and chief executive officer of Alder Biopharmaceuticals, “Alder is changing the paradigm for the treatment of migraine from abortive care at the time of migraine onset to a preventative approach, and our team has developed a highly specific therapeutic candidate with the potential to prevent the disorder before it begins that we believe has the ability to make a large impact in migraine. This preventative approach has been welcomed by patients, evidenced by the significant patient interest at all of our trial sites, and we are proud to advance ALD403 into a proof-of-concept trial while exploring additional applications for our core technologies with therapeutic candidates in other disease areas.”

Research has shown that CGRP has a role as a trigger for migraine attacks, and inhibiting the peptide has demonstrated promise in preventing the onset of migraines. ALD403 is expected to be developed for patients experiencing multiple migraines per month with self-administered infrequent dosing.

Alder’s core technology enables the production of antibodies in very high quantities via its Mab Xpress technology, allowing this class of therapeutics to enter disease areas that have previously been inaccessible for antibodies, such as migraine and cardiovascular disease. Proof of concept for this technology was achieved with clazakizumab, previously known as ALD518, a monoclonal antibody to the pro-inflammatory cytokine IL-6, which is currently under Phase 2 development by Bristol-Myers Squibb for autoimmune diseases (BMS-945429), while Alder is developing the antibody for cancer-related conditions.

About Alder Biopharmaceuticals

Alder Biopharmaceuticals Inc. uniquely identifies, develops and manufactures novel antibody therapeutics to alleviate human suffering in cancer, pain, cardiovascular and autoimmune and inflammatory disease areas. The company’s second therapeutic program, an investigational monoclonal antibody for migraine, ALD403, inhibits a well-validated molecule shown to trigger migraine attacks, calcitonin gene-related peptide (CGRP), and is now in clinical trials. Clazakizumab, previously known as ALD518, is Alder’s investigational monoclonal antibody to the pro-inflammatory cytokine IL-6. Alder is developing clazakizumab in Phase 2 clinical studies in multiple cancer-related conditions, while Bristol-Myers Squibb is investigating the asset (as BMS-945429) in a Phase 2b clinical study in rheumatoid arthritis and other autoimmune indications based on a 2009 partnership. Alder’s management team combines decades of industry experience with a proven track record for identifying and developing novel antibody therapeutics and enabling partners through the out-licensing of its technologies. For more information, visit Multimedia File Viewing and Clickable Links are available for Registered Members only!!  You need to or .

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