Ness Ziona, Israel, November 5, 2012. Kamada Ltd. (TASE: KMDA), an Israeli biopharmaceutical company, specializing in development, manufacturing and marketing of specialty plasma bio-therapeutics by intravenous or inhaled route for life saving uses is now reporting a new promise stemming from several pre clinical studies with its AAT product. These breaking news further support the scientific and clinical rationale behind Kamada's already in-development AAT drug for diabetes indication as well as promote its possible entry to develop additional indications for this protein. Based on the results, Kamada reports that its AAT protein is modulating the activity of type B lymphocytes and by that enables the avoidance of organ transplant rejection and raises the likelihood for the transplant success.
Furthermore, the results show that presence of the Kamada AAT protein in the serum of AAT-treated rats has led to a significant elevation of other protective proteins such as IL-10 cytokine, IL-1 Receptor Agonist, known for their powerful anti inflammatory properties. This elevation was significantly higher vs the control group which was not treated with Glassia. One of the main conclusions of these studies that were published in the recent immunology conference in Scotland (ECI 2012) was that presence of the Kamada-AAT protein decreases the likelihood of transplant rejection and thereby supports the success of any organ transplantation. In addition, it was found that in the presence of Kamada-AAT protein in serum, pro-inflammatory proteins (proteins that support the occurrence of inflammation) are inhibited. For example, in the presence of AAT, Heat Shock Protein, a well known pro-inflammatory protein also active in the occurrence of type 1 diabetes, is inhibited.
Dr Eli Lewis: “we presented 6 research studies in the recent conference, all share a common approach where AAT that is present in the Kamada Glassia drug may potentially serve as a safe treatment in different illnesses. All six studies we presented reveal new therapeutic properties in the AAT molecule. These findings are ground breaking in AAT research as well as in medicinal research as they present ways by which the immune system can be safely and efficiently modulated by AAT. These findings also place our research lab as an international leader in understanding the AAT characteristics with all that concerns to re-educating the human immune system. Definitely, a sense of patriotic pride being an Israeli lab that supports considerably to the recent gained interest in this molecule. “
Kamada sees in these studies as another basis as well as an additional supportive rationale to the administration of AAT in type 1 diabetes, namely since the root cause of beta cell damage and loss of insulin secretion in T1D is the severe inflammatory process in these cells. By inhibiting the inflammation, the damage to the beta cells in the pancreas will decrease and may even be halted. Kamada believes that despite the fact that these are only preclinical results, these results are a positive indication for the potential of treating type 1diabetes and other inflammatory diseases.
Kamada is expected to publish during November 2012 the final results of its phase 2 clinical study in type 1 diabetes with the Glassia drug. The interim report of this study published earlier this year demonstrated positive results. The results showed a beneficial trend in the diabetic parameters sided to a high safety profile in approximately 20 pediatric patients. These results are quite unique in the scenery of previous T1D studies that were also aiming to withhold damage to beta cells. Yet, previous studies were lacking of complete results or had related adverse events that could not be tolerated by the patients.
Moreover, in another study it was presented for the first time that AAT-treated mice with bacterial lung infection had a substantially better prognosis than the untreated group. This was expressed in a slower decline disease progression and a lower bacterial load. The scientists hypothesize that AAT by Kamada is able to prevent the bacterial colonization in the lung tissue and by that prevent the infection. In similarity to the T1D concept, this treatment approach holds a major safety advantage and therefore could potentially accompany immune-suppressants treatments that pose the risk of a sided bacterial infection, that sometimes could be lethal.
Dr Eli Lewis: “it seems that bacteria is exploiting the inflammation and tissue damage in order to overcome immune system barriers of the body. AAT is interfering with the inflammation and the tissue damage during state of infection and by that leaving the bacteria with an “unfruitful” ground to colonize. As a supporting evidence, the two other places in the human body that produce and release AAT are the lungs and intestine – both are constantly exposed to bacteria in high rate.
Recently, different studies, worldwide, have demonstrated that the AAT molecule has distinctive locations that enable it the specific functions of anti inflammation, immune-modulation, anti bacterial properties and tissue protective characteristics. These new identified roles lead to an innovative clinical concept in which AAT can potentially treat an illness in which the body is lacking one or more of the above discussed properties. For example, within its tissue protective capabilities, AAT also demonstrated promise in reducing the infarct size (cardiac tissue damage) following the occurrence of a myocardial infarction event. This activity has a major clinical benefit for heart patients and their prognosis and recovery following a cardiac event.
In the respiratory field, Kamada has a registered patent for treatment of COPD exacerbation events during which there is a severe burst of inflammation in the lungs. Under the same rationale, being an immense anti inflammatory agent, AAT can provide an answer and ease/ shorten the duration, severity and frequency of these events which are of a considerable clinical need in these patients.
Other diseases in which anti-inflammatory answers and immune modulating requirements are in need include chronic intestinal bowl disease, type 2 diabetes, multiple sclerosis, rheumatoid arthritis and more. These diseases and additional indications are also appearing in the recent review published by Dr Eli Lewis in the journal of Molecular Medicine.
David Tsur, CEO of Kamada:”these study results serve as an encouraging indication for the potential efficiency of the drug we have developed and support the advisability of developing this drug for new indications. These findings also strengthen the likelihood that the AAT properties will also be confirmed in clinical study results and we are hopeful that it will serve the company as part of its progress in diabetes indication as well as others. The results support the business potential of the Kamada AAT drug, which was initially presented in an intravenous administration and is currently being marketed in the US for the AAT deficiency indication for tens of millions of dollar per year. Additionally, the results further validate Kamada's future development strategy and its ability to enter into new and high-value indications as well.”
Kamada recently announced the completion of patient enrollment in its pivotal phase 2-3 study with AAT by inhalation for the treatment of AAT deficiency, currently ongoing in western EU and Canada sites. The study completion is expected in the 4th quarter of 2013. Sided to this announcement, Kamada recently signed a strategic agreement with the Italian pharmaceutical firm, Chiesi Farmaceutici S.p.A, a leader in respiratory drug solutions, for the exclusive distribution of Kamada's inhaled AAT in EU for treatment of AAT deficiency.
According to the agreement, Kamada will receive approx 60 million dollars for regulatory and sales milestones. The company estimates that the sales potential following this agreement and upon successful clinical and regulatory achievements of the inhaled drug, could reach hundreds of million dollars in the next few years.
Additional information is available at www.kamada.com
This notice contains forward-looking statements including, with respect to the conduct clinical trial, the regulatory recognition of such results and future sales. Such statements express the current beliefs and expectations of Kamada's management and involve a number of known and unknown risks and uncertainties that could cause Kamada's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements.