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Northwest Bio Proceeding With A Phase I/Ii Clinical Trial Of Dcvax®-Direct For All Solid Tumor Cancers

(OTC.BB: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for , announced today that it is in late stage discussions with medical centers in the U.S. and Europe to proceed with a Phase I/II clinical trial with the Company’s third major product line, DCVax®-Direct, for all types of solid tumor cancers (i.e., cancers in any tissues). The Company previously received FDA approval of the clinical trial.

DCVax®-Direct offers a potential new treatment option for the wide range of clinical situations in which patients’ tumors are considered “inoperable” because the patient has multiple tumors, or their tumor cannot be completely removed, or the surgery would cause undue damage to the patient and impair their quality of life. A large number of patients with a variety of cancer types (including lung, colon, pancreatic, liver, ovarian, head and neck, and others) are faced with this situation, because their tumors are already locally advanced or have begun to metastasize by the time symptoms develop and the patients seek treatment. For these patients, the outlook today is bleak and survival remains quite limited.

DCVax®-Direct is administered by direct injection into a patient’s tumors. It can be injected into any number of tumors, enabling patients with locally advanced disease or with metastases to be treated. DCVax®-Direct can also be injected into tumors in virtually any location in the body: not only tissues at or near the surface of the body but also, with ultra-sound guidance, into interior tissues.

The Phase I/II trial with DCVax®-Direct will treat 36 patients in two parts. In Part 1, 24 patients with any type of will be treated in groups with escalating dose levels. Then, in Part 2, an additional 12 patients with any selected cancer will be treated with the optimal dose.

When DCVax®-Direct was administered in pre-clinical animal studies, existing tumors regressed. Importantly, the tumors that regressed included not only tumors that were injected with DCVax®- Direct but also tumors on the opposite side of the animal’s body which were not injected, indicating a systemic immune response. Further, when the animals were subsequently challenged (i.e., injected) with cancer cells, the animals did not re-develop cancer, indicating immune memory. Notably, the Company’s proprietary activation step for the appeared to be essential for these results.

“This broad Phase I/II trial, allowing DCVax®-Direct to be used for all solid tumor cancers, is a very significant development for us and will enable us to make faster and more efficient clinical progress for multiple cancers than would usually be the case” commented Linda Powers, CEO of NW Bio. “Based upon the pre-clinical studies showing regression of existing tumors, DCVax®-Direct may offer a much needed new treatment option for patients suffering with inoperable tumors today.”

DCVax®-Direct is based upon the same platform technology as the Company’s first two major product lines (DCVax®-L and DCVax®-Prostate). This technology utilizes the patient’s own dendritic cells – the master cells of the . Each product line involves two key ingredients: the dendritic cells (which are activated to mobilize the to attack the patient’s cancer), and biomarkers of the patient’s tumor (which identify the targets for the to attack).

For DCVax®-Direct, the dendritic cells are activated in a special proprietary manner, to enable them to be directly injected into the patient’s tumors, and to pick up the biomarkers of the tumors onsite in the tumor. The “educated” dendritic cells then proceed to mobilize the immune system to attack any tumors bearing those biomarkers.

DCVax®-Direct is the Company’s third major product line. The Company’s first product line, DCVax®-L, is potentially applicable for all solid tumor cancers in which the tumors can be surgically removed. DCVax®-L is currently in a 300-patient randomized for Glioblastoma multiforme brain cancer.

The Company’s second product line, DCVax-Prostate, is for hormone independent prostate cancer, and has previously been cleared by the FDA for a 612-patient randomized Phase III clinical trial. The Company plans to enter into a partnership in order to proceed with this Phase III trial program.

For further information about the Company and its programs, please visit the Company’s website at http://www.nwbio.com.


Northwest Bio