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April 09, 2013 at 08:45 AM EDT
Vaxil Reports Positive Results From a Phase I/II Clinical Trial Using Its Therapeutic Cancer Vaccine, ImMucin, In Patients With Multiple Myeloma

NES-ZIONA, Israel, April 9, 2013 (GLOBE NEWSWIRE) -- Vaxil Bio, (TASE:VAXL.IT) is pleased to announce that its wholly owned subsidiary, Vaxil BioTherapeutics (together "Vaxil" or the "Company"), which is developing therapeutic vaccines for the treatment of cancer and infectious diseases, has reported that a Phase I/II clinical trial (VAXIL-001) of the Company's therapeutic vaccine, ImMucin, in 15 patients with Multiple Myeloma (a hematological cancer), has met all endpoints with considerable success.

All patients enrolled in this study were experiencing a gradual re-emergence of the disease after a period of remission that had been attained following an autologous stem cell transplantation. The results indicate a high safety profile for ImMucin. In addition, 100% of the patients demonstrated a strong immunological response to ImMucin. Furthermore, nine of the fifteen patients demonstrated a clinical response. Of these, five patients ended the study in a state of Complete Response and a further four ended the study with Stable Disease, which requires no further treatment.

The VAXIL-001 trial was carried out in two Israeli medical centers: Hadassah Ein Kerem University Hospital in Jerusalem and Rambam Medical Center in Haifa. Patients received either six or twelve ImMucin injections (administered intra-dermally) at a dose of 100 or 250 micrograms, along with GM-CSF (Leukine) at a dose of 250 micrograms.

The ImMucin vaccine is a unique 21 amino acid sequence (peptide) taken from the MUC1 antigen (cancer marker) which is expressed on the Myeloma cancer cells. ImMucin educates the patient's immune system to identify and destroy cells which express this particular antigen.

Dr. Lior Carmon, Vaxil's CEO, noted, "We are very pleased with the results of this clinical trial. The study achieved all of the goals we set and provides a very encouraging view regarding the future development of this vaccine, as well as a validation in patients for Vaxil's VaxHit technology. Naturally, we intend to publish the full results of this clinical trial in an appropriate scientific journal as soon as possible."

VAXIL-001 Primary End-Point: Vaccine Safety

The results of ImMucin treatment, combined with Leukine, indicated a very high safety profile, with no side effects observed except for minor local irritations which were all resolved within 24 hours without any additional treatment or medical intervention.

VAXIL-001 Secondary End-Point: Immunological Activity

There was a strong, specific and broad immunological response in 100% of the patients treated with ImMucin after as few as 2-to-4 treatments. Two doses were tested - 100 and 250 micrograms - and the results indicated 100 micrograms was the optimal dosage.

ImMucin caused a strong immune response of both CD4+ and CD8+ T-cells in all fifteen patients. In addition, a strong antibody response towards ImMucin was observed in 65% of the patients.

Although not being pre-defined as a secondary end-point, the antibody response is significant, as, to the best of the Company's knowledge, this combination of T-cells and antibodies is important in attacking cancer cells and does not exist in other MUC1 vaccines.

Moreover, these results in patients with a wide range of different immune repertoires support the Company's hypothesis of the ability of ImMucin to activate the patient's immune system without the need for personalization.

VAXIL-001 Secondary End-Point: Signs of Clinical Response

As a result of ImMucin treatment, nine patients demonstrated a positive clinical response. This included a reduction or stabilization in FLC and M Protein markers, the accepted indicators for status and progression of Myeloma, providing an initial indication of potential vaccine efficacy. Another patient showed a significantly slower progression rate during the vaccine treatment as compared to its rate before treatment.

In addition, following treatment with ImMucin, a significant reduction in soluble MUC1 levels (in serum) was observed in all the patients who demonstrated high levels when entering the trial. This indicates a specific targeting and attacking of the cancer cells and, therefore, the efficacy of the treatment. Furthermore, a decrease or stabilization in the percentage of plasma cells in the bone marrow was observed one month after the end of treatment. 

At the end of the trial, the Principal Investigators classified five of the patients as being in a state of Complete Response, four of the patients in a state of Stable Disease, requiring no further treatment and six of the patients with Progressive Disease. As mentioned above, of the six Progressive Disease patients, one had demonstrated a significant decrease in the progression rate for a period of time while undergoing treatment.

DISCLAIMER: It is hereby clarified that nothing in this information provides any certainty that the results of future studies involving the therapeutic vaccine ImMucin will be positive and/or will meet future study endpoints and/or that ImMucin will be proven to be effective or safe for use, and/or that Vaxil and/or any future partners of Vaxil will be able to attain regulatory approval to market ImMucin from the appropriate regulatory authorities such as the FDA. Furthermore, there is no certainty that Vaxil will be able to raise the required funding to complete the clinical development of the ImMucin vaccine.

About Vaxil

Vaxil BioTherapeutics Ltd. ("Vaxil"), an Israeli clinical stage biotechnology company, is a wholly owned subsidiary of Vaxil Bio (VAXL.IT). Vaxil is developing therapeutic vaccines to treat cancer and infectious diseases. The company's vaccines are based on its proprietary technology, VaxHit, which identifies vaccine candidates (Signal peptide domains) with the ability to create a specific, strong and promiscuous reaction in various immune system types (PAN-HLA). As opposed to traditional prophylactic vaccines which protect healthy people from disease, a therapeutic vaccine takes sick people and seeks to harness their immune system to identify and destroy cancer cells (or pathogens in the case of infectious diseases) in a safe, efficient and focused manner, typically with far fewer side effects than other cancer treatments. From the patient's perspective a therapeutic vaccine is a drug. Vaxil was founded in 2006 by Dr. Lior Carmon, an expert in cancer immunotherapy, who holds a PhD from the Weizmann Institute in tumor immunology, and Julian Levy, a seasoned biotechnology entrepreneur who holds an MA from Cambridge University in Law. The two have considerable experience founding and running biotech ventures.

Vaxil's Vaccines under development

ImMucin:  Vaxil's lead product, ImMucin, teaches the patient's immune system to identify and destroy cells which display the cancer marker MUC1. Because MUC1 appears on over 90% of all cancers, ImMucin has the potential to be used against a wide range of cancers.

ImMucin has a number of specific characteristics which differentiate it from other therapeutic vaccines which target MUC1. First, the specific sequence is only found on the cancer cells and not in soluble form in the blood, (thereby increasing the potency of the immunological response). In addition, ImMucin can initiate a combined activation of multiple subsets of immune cells. Furthermore, ImMucin can be offered to a very wide section of the population with no need for complicated and expensive personalization or prior selection based on the patient's immune system. Finally, ImMucin has a unique property that may enable it to cope with the tendency of the tumor to evade the immune response (TAP deficiency) and develop resistance to treatment.

In 2013, ImMucin successfully completed a Phase I/II study in patients with Multiple Myeloma, meeting all the study endpoints. The Company is planning a Phase II study in Myeloma and an additional study in a solid tumor (e.g. breast or lung cancer).

MTBuVax: Vaxil is also developing MTBuVax, a therapeutic vaccine for tuberculosis ("TB"). Globally, TB is one of the largest causes of mortality. Although most TB cases occur in developing countries, over the last few years, there has been an increase in incidence rates in the western world due to the low efficacy of the current TB vaccine (BCG), increased global travel movements, the mutation of the TB bacteria to new strains which are resistant to drug treatment and a strong link of TB with HIV infection. MTBuVax, is in pre-clinical studies.

CONTACT: Michal Efraty
         Adi & Michal Public and Investor Relations
         +972-52-3044404
         michal@efraty.com
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