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OPT-822/821 targets Globo H. 60-80% expressed.

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Opt821/822. #asco16 #bcsm.

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Opt821/822 vaccine trial design.

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Trend toward improved overall survival in OPT 821/822. #ASCO16 #bcsm

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Patients who responded did better than placebo but exposure to vaccine hurt non responders. #Asco16 #bcsm.

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Summary: vaccine trial didn¡¦t meet primary end point of Progression free survival. #ASCO16 #bcsm

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--------------------
Serenity (Jennifer) Kisling¡¦s family and friends are uniting to raise money to help with her battle against Breast Cancer. Please help.
Friends, Family and complete Strangers unite in support of Serenity¡¦s NEXT STEP 4 LIFE!

My life partner, Serenity Kisling, was diagnosed in 2008 with breast cancer, not wanting to take any chances of a re-occurrence she under went a bilateral mastectomy and through grueling rounds of several types of chemo that made her extremely sick, radiation and a surgery having her ovaries and fallopian tubes removed and many medications she is still fighting to save her life. She has been so close to death twice now but she is a tenacious fighter and this has earned her the name G.I. Jane!
Serenity has a life to live; she has someone to live for, her 7 year old son Shade. She cannot succumb to this bastard of a disease! In August of 2009 sitting in her oncologist¡¦s office Serenity got the long awaited news her family and friends had been hoping for, that magic word Remission. Sadly this did not last long. After myself and her family and friends watched her suffer in pain for over a year on the 2nd of November 2011 her oncologist at the time diagnosed her with Stage IV Metastatic Breast Cancer. It was in her right lung, left thyroid and ovaries but most painfully and extensively in her bones (bone metastases).
Now being treated at the renowned MD Anderson Cancer Center in Houston, TX Serenity has the opportunity to be in one of the over 700 clinical trials that MD Anderson Cancer Center heads up. This is a long awaited answer to prayers. Serenity is so excited about this opportunity, actually that is an understatement: she is ecstatic and so am I, her family, and friends. However this does not come without a price. Serenity will once again have to live in Houston, TX for the first 30 days of the 41 week trial and then return every two weeks for a week for almost a year. She will have enormous medical related expenses. This is where all of you come in. I, once again, humbly ask for your donations. One in two patients will receive the vaccine......this is great odds and could potentially prolong her life if not completely put Serenity in remission for a very very long time.
The specifics of the trial are as follows: 2012-0408 A Double-blind, Randomized Phase II Trial of Active Immunotherapy with Globo H-KLH (OPT-822) in patients with Metastatic Breast Cancer. The most concerning side effect will be the nausea as she will be receiving a small amount of chemotherapy with the vaccine. The doctors will treat her with anti-nausea medication as they administer the vaccine as well as making sure she has a prescription for her nausea.
I am unable to be with her throughout the entire trial so I ask for your continued support, healing thoughts and prayers. Please go to her FaceBook page: www.facebook.com/serenitysjourney to stay updated on her Next Step 4 Life journey. Thank you so very much for your donations.

With Gratitude, her life partner,

Tamara

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Randomized phase II/III trial of active immunotherapy with OPT-822/OPT-821 in patients with metastatic breast cancer.

Abstract:
Background: Globo H is a glycolipid that is highly expressed in breast cancer (BC). Active immunotherapy with OPT-822, a Globo H¡VKLH conjugate, and the adjuvant OPT-821 in 2 phase (Ph) I trials, induced Globo H specific antibodies which could mediate in vitro binding and cytotoxicity to Globo H expressing BC cells.

Methods: In this international, randomized, double-blind, placebo-controlled Ph II/III trial (NCT01516307), patients (pts) with metastatic BC who had ≤ 2 events of progressive disease (PD) and who achieved at least stable disease (SD) after ≥ 1 anticancer regimen were randomized 2:1 to receive subcutaneous OPT-822 (30 £gg Globo H)/OPT-821 (100 £gg) or control (PBS) on weeks 1, 2, 3, 5, 9, 13, 17, 25, and 37 or until PD, in combination with low-dose cyclophosphamide (300 mg/m2). Hormone therapy was allowed. The primary and secondary efficacy end points were progression-free survival (PFS) and overall survival (OS), correlated with humoral antibody response.

Results: 349 pts were randomized, 348 received study drug (ITT), 168 (48%) received all 9 injections. 70% had hormone receptor positive BC, 13% were triple negative, and 62% received hormone therapy. No difference was observed in PFS (HR, 0.96 [95% CI, 0.74-1.25] P = .77) or in interim OS (HR, 0.79 [95% CI, 0.51-1.22] P = .29). However, PFS and OS were significantly improved in the 50% of pts who developed a Globo H specific IgG response to OPT-822/OPT-821 with a titer ≥ 1:160 at any time during treatment vs control (HR, 0.71 [95% CI, 0.52-0.97] P = .029 for PFS; HR, 0.57 [95% CI, 0.33-0.97] P = .04 for OS) and vs nonresponders (HR, 0.52 [95% CI, 0.37-0.71] P< .0001 for PFS; HR, 0.52 [95% CI, 0.29-0.92] P = .025 for OS), adjusted for baseline disease status/hormone use. In a time-dependent Cox model, PFS was improved in pts who received all 9 injections of OPT vs control (HR, 0.66 [95% CI, 0.42-1.01] P= .057). OPT-822/OPT-821 was well tolerated; the most common drug-related adverse event was grade 1/2 injection reaction.

Conclusion: Vaccination with OPT-822/OPT-821 did not improve PFS in the ITT; however, PFS and interim OS were significantly improved in pts who developed an immune response to the vaccine. These subgroup data will be used to design a definitive Ph III trial. Clinical trial information: NCT01516307

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OTHER EXCEPTIONS
2 Most abstracts will be publicly available online at ASCO¡¦s Meeting Library approximately two weeks before the Annual Meeting, with late-breaking abstracts becoming publicly available during the Annual Meeting outside of market hours. Exact posting dates and times will vary from year to year. Press releases issued at or after ASCO¡¦s public release do not violate ASCO policies.
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