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Multikine® Key Benefits
The FIRST, FIRST-LINE immunotherapy: Multikine® is the first immunotherapeutic agent being developed as a first-line treatment for cancer. It is administered prior to any other cancer therapy because that is the period when the anti-tumor immune response can still be fully activated. Once the patient has had surgery or has received radiation and/or chemotherapy, the immune system is severely weakened and is less able to mount an effective anti-tumor immune response. To date, other immunotherapies have not been administered later in cancer therapy (i.e., after radiation, chemotherapy, surgery).
One of the reasons other immunotherapies have had limited success is because they are administered only after radiation, chemotherapy and surgery. The latest scientific leaders’ thinking is that immunotherapy must be used early in the disease process and a combination of therapies may be needed to overcome cancer.
First-line Treatment Advantages:
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The first-line market is much larger than the recurrent cancer market. Multikine® (following approval) would be part of standard of care for every head and neck cancer patient’s initial treatment. This means every patient diagnosed with the disease should receive Multikine®. |
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Only a small specialized sales force is needed to target head and neck surgeons, particularly for a standard of care drug. |
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Safety: Multikine® has been shown to be safe and well-tolerated with no added toxicity in multiple studies conducted in the USA, Canada, Europe and Israel. This is highly significant as traditional cancer therapies like radiation, chemotherapy and surgery are all highly toxic and invasive. Some immunotherapies like mAbs have also been reported to have severe adverse events associated with their use.
Its effect on recurrence of cancer: Radiation, chemotherapy and surgery do not always succeed in killing all the tumor cells. The persistence of these cells is responsible for cancer recurrence. Multikine® is injected around the tumor and in the vicinity of the local lymph nodes because these are the areas where metastases are most likely to develop and where the cancer will recur. Multikine® empowers and then unleashes the immune system’s ability to target and kill those tumor cells before they can cause tumor recurrence.
Off the shelf product / does not need to be customized: Multikine® is mass-produced under Good Manufacturing Practices (meeting or exceeding all FDA and ICH regulations) and is being developed as a ready-to-use anti-cancer immunotherapy for many types of cancers. As opposed to certain cancer vaccines, Multikine® does not need to be customized or developed from the patient’s own cells. It is readily and immediately available for use – an off the shelf medication.
Multikine is developed in a dedicated manufacturing facility
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The facility is located outside Baltimore, Maryland, USA, a $25 million commercial size cGMP Drug Production facility dedicated to Multikine. |
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The facility includes a True Cold Fill (+4°C) capability to avoid loss of biological activity during fill, and meets US and European regulations. |
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The facility will supply the Phase III study as well as the subsequent commercial sale of Multikine – following approval of Multikine. The current capacity is about 20,000 treatments annually, while the fully built-out capacity will be approximately 60,000 treatments annually – from the same facility. |
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Multikine® has combination immunotherapy activity; it simultaneously kills cancer cells and stimulates the immune system to destroy the cancer. It is multi-targeted and acts through a multitude of pathways to destroy the cancer. These combined activities make Multikine® the closest simulator of a healthy person’s immune system, which battles cancer every day.
One immunotherapy vs. a mixture of immunotherapies: Multikine® is a defined combination of natural cytokines; each of its molecular components is present in similar proportions as would be seen if it were secreted directly by a healthy immune system. The advantage of Multikine® is that the clinician does not need to experiment to find the right combination of immunotherapeutic agents for his/her patient.
Furthermore, because Multikine® is made from healthy donors’ immune system cells and is readily available as a ready-to-use anti-cancer immunotherapy, it can be administered to any patient immediately and without delay.
Potentially useful for multiple tumors: Multikine® may be useful against many different cancers. Multikine® has already shown biological activity in clinical studies, in both cervical dysplasia/neoplasia and prostate cancer.
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