Lani - Vaccine based on Smallpox

[Jackie07]

http://clinicaltrials.gov/show/NCT00485277


Joe,

Lani did not post it because Eric had already posted it in 2006: [10-30-2006, 01:45 PM]

http://www.biotech-intelligence.com/...aa8194085.html

MVA-BN®-based vaccine shows promise in breast cancer modelsBavarian Nordic (DENMARK)October 30, 2006 BN ImmunoTherapeutics, Bavarian Nordic’s California-based subsidiary developing vaccines against cancer, recently presented preclinical study data with the MVA-BN®-HER2 vaccine showing exceptional and significant efficacy, both in terms of inducing broad immunity as well as anti-tumor activity. In addition, immunization with MVA-BN®-HER2 showed to induce an antigen-specific Th 1-type CD4 T-cell respons, Her-2 specific CD8 cytotoxic T-lymphocyte respons, and anti-Her-2 antibodies.

These promising results will be included in BN ImmunoTherapeutics’ current filing for an Investigational New Drug application (IND) with the US Food and Drug Administration (FDA). The vaccine has been released from the Berlin facility and with regulatory approval, Phase I studies with MVA-BN®-HER2 are due to start before the end of 2006.

Results from the MVA-BN®-HER2 breast cancer vaccine program were presented at the 21st Annual Meeting of the International Society for Biological Therapy of Cancer in Los Angeles, California (October 26-29, 2006).

MVA-BN®-HER2 showed activity in both preventive as well as therapeutic settings in multiple animal models with Her-2 expressing tumors. In the most dramatic model (14-day experimental, highly aggressive lung metastasis model), MVA-BN®-HER2 nearly eradicated the tumor by the 14-day evaluation point. Equally impressive in this model was that a single injection of MVA-BN®-HER2 administered as late as 3 days after the intravenous induction of the experimental lung metastasis, resulted in the same effect – near eradication of an aggressive metastasis. Moreover, MVA-BN®-HER2 induced an extremely rapid antigen-specific immune response.

Peter Wulff, President & CEO, Bavarian Nordic said: “With these promising results based on our patented MVA-BN® technology,we have taken our first important step towards clinical trials with our cancer vaccines which we expect to be one of the company’s cornerstones in the future.”

Kvistgård, 30 October 2006

Asger Aamund
Chairman

Contacts:

Peter Wulff, President & CEO, Tel.: +45 33 26 83 83
UK (media): Mary Clark, Capital MS&L, Tel.: +44 20 7307 5330
USA (media): Ken Arnold, T. Dean Reed Company, Tel.: +1 202 223 3532

About Bavarian Nordic:

Bavarian Nordic (CSE: BAVA) is a leading international biopharmaceutical company developing and producing innovative vaccines to prevent and treat infectious diseases and cancer. With operations in Denmark, Germany, the USA, and Singapore, Bavarian Nordic employs over 200 people.

Bavarian Nordic’s patented technology, MVA-BN®, is as been demonstrated in clinicial studies, one of the world’s safest, multivalent vaccine vectors for the development of vaccines against various infectious diseases such as smallpox, HIV/AIDS, as well as against breast and prostate cancer.

For more information please visit www.bavarian-nordic.com

[Jackie07]

Eric posted this when the trial became available in the beginning of 2007:

http://today.reuters.com/news/articl...&from=business

COPENHAGEN, Jan 3 (Reuters) - Danish vaccine maker Bavarian Nordic (BAVA.CO: Quote, Profile, Research) said on Wednesday that its U.S. subsidiary BN ImmunoTherapeutics received approval from the U.S. Food and Drug Administration (FDA) to start clinical trials with the breast cancer vaccine MVA-BN-HER-2.

Patient enrolment in a Phase I/II study in the United States will start as soon as possible, Bavarian said.

BN ImmunoTherapeutics also plans to start a Phase I/II study with the vaccine in Europe.

The two studies are expected to enroll up to 60 patients and are designed to evaluate the safety and tolerability of the vaccine. Its effect on the clinical progress of the patients and on tumor growth will also be explored.



To determine how best to incorporate the vaccine into standard therapy, it will also be tested in combination with traztuzumab (Herceptin) and chemotherapy.

In Europe, the vaccine will also be tested in first-line therapy of metastatic breast cancer, Bavarian said.

[Joe]

I was aware of the trial as we had posted it on our Featured Clinical Trials Page.

I only mentioned it because Lani is from Scandanavia.

Regards
Joe