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Jerusalem, Israel, June 30, 2016 – Vidac Pharma, a clinical stage oncology focused pharmaceutical company, today announced that the Company has completed a Phase 1a trial of VDA-1102 ointment, a topical ointment formulation of VDA-1102, a potent selective VDAC/HK2 modulator, for the treatment of actinic keratosis (AK) and other hyperproliferative dermatological conditions. The drug candidate is being developed by Vidac as a first-in-class treatment for actinic keratosis featuring potency, safety, and tolerability at the same time.

“We are pleased that the outstanding safety profile established in preclinical testing continues to be seen in this human clinical trial," said Dr. Chaim M. Brickman, Vice President of Medical Affairs at Vidac. "The clinical data gathered so far lends further credence to Vidac’s plans to develop VDA-1102 ointment as a safe, well-tolerated, and efficacious AK treatment."

"This first clinical trial of VDA-1102 has proceeded exactly as planned and we are encouraged with the results to date," said Dr. Oren M. Becker, Vidac's President and Chief Executive Officer. “The convincing safety and tolerability data from this Phase 1a clinical study serve as solid foundations for our Phase 2 development program. Furthermore, this trial confirms the ability of the Company to quickly convert novel discoveries into solid clinical development programs.”

About the Phase 1a Study

The Phase 1a clinical trial was a randomized, double-blinded, placebo-controlled, dose-escalation study in healthy older-adult volunteers to evaluate the safety, tolerability, and pharmacokinetics of a single topical dermal application of VDA-1102 ointment. The study was conducted under FDA IND in a Phase 1 unit in the United States.

Fifteen healthy volunteers, aged 35-70, were sequentially assigned to 1 of 3 consecutive treatment cohorts (5%, 10% or 20% VDA-1102 ointment, respectively). Five subjects were randomized in a double-blind fashion in each dose cohort: 4 subjects to receive active VDA-1102 ointment and 1 to receive matched placebo (0% VDA-1102; vehicle control). The study ointment assigned was applied once to a 25 centimeter squared area of skin on the forehead of each volunteer.

The Phase 1a study demonstrated:

*  No serious adverse events;

*  No clinically significant changes at the study drug application sites or in vital signs, physical examinations, clinical laboratory results, ECGs, and Holter monitors for any individual subject at any time point regardless of treatment assignment;

*  All adverse events were mild, short-lived and reversible; and

*  No systemic exposure of either VDA-1102 or its major metabolite following a single topical application.

 

About VDA-1102

VDA-1102 is a novel selective modulator of the VDAC/HK2 complex in cancer cells. The drug triggers a dissociation of HK2 from VDAC leading, among other effects, to apoptosis and death of the malignant cells. The selective nature of VDAC/HK2 dissociation targets only cancer cells without affecting the surrounding healthy tissue. VDA-1102 is being developed as a topical ointment for treatment of pre-malignant and malignant hyperproliferative skin conditions, such as AK, cutaneous squamous cell carcinoma (cSCC), and cutaneous T-cell lymphoma (CTCL). VDA-1102 is also being developed as an injectable for treatment of solid tumors.

About Actinic Keratosis

Actinic keratosis (AK) is one of the most common dermatologic conditions worldwide. It effects an estimated 58 million people in the United States alone. In 2015 the global AK market was estimated at $6.6 billion. This skin disease occurs predominantly in older males with fair skin and most often begins as a rough red patch that may progress to a thicker, scaly, and unsightly skin lesion. AK is considered by many as an early form of cSCC. Thus, treatment is most commonly recommended by physicians in order to prevent cSCC. Current therapies are inadequate and pose significant disadvantage to public health. The limited tolerability of current treatment options greatly decrease the willingness of patients to be retreated and/or compliant. AK is a chronic disease for which patients often require repeat treatments. As a result patients with this prevalent condition elect to avoid treatment, seeking medical help only later, after their lesions have become esthetically intolerable or have advanced to malignant cSCC tumors.

About Vidac Pharma

Vidac Pharma is an innovative clinical stage oncology focused pharmaceutical company, developing novel drugs to help people suffering from a range of oncologic and dermatologic diseases. Vidac’s breakthrough technology targets the VDAC/HK2 system that is unique to malignant cells. The mechanism-of-action of these drugs leads to selective apoptosis of cancer cells without affecting the surrounding healthy tissue, leading to well tolerated and efficacious treatments. Vidac is also developing VDA-1102 injections as a systemic treatment for solid tumors. For more information regarding Vidac Pharma, please visit www.vidacpharma.com.

Contact: Shelly Majar +972-2-5952090  

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Jerusalem, Israel, July 29, 2016 – Vidac Pharma, a clinical stage oncology focused pharmaceutical company, today announced that the Company has initiated a Phase 2 trial with VDA-1102 ointment, a potent selective VDAC/HK2 modulator, to treat subjects with actinic keratosis (AK), an early form of cutaneous squamous cell carcinoma (cSCC). The drug candidate is being developed by Vidac as a first-in-class treatment for actinic keratosis featuring potency, safety, and tolerability at the same time.

Like many other types of cancer, cSCC and AK express high levels of the HK2 enzyme that is essential for their transformation and proliferation. VDA-1102 is a selective VDAC/HK2 modulator that disrupts the interaction between HK2 and VDAC specifically within cancer cells, destroying AK lesions without affecting the surrounding skin. VDA-1102 is thus suitable for field treatment of AK and has the potential to address a significant unmet medical need by mitigating the current situation where people avoid both initial treatment and the often required re-treatment of their disease due to the disadvantages and untoward findings associated with existing AK field treatments.

“VDA-1102 represents potentially a major advance in the treatment of AK, SCC, and the cancerization of large areas of skin regularly exposed to sunlight,” according to Dr. Chaim Brickman, Vice President of Medical Affairs at Vidac. “Considering the outstanding skin and systemic safety profiles of this drug, VDA-1102 could significantly change both the medical and surgical approaches to skin cancer in the near future.” 

About the Phase 2 Study

The Phase 2 clinical trial is multiple-center randomized, double-blind, placebo-controlled, parallel-cohorts study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of once daily application of topical VDA-1102 ointment for 28 days in subjects with actinic keratosis. Subjects will be followed for two months after end of treatment (through day 84). The endpoints for the study are reduction in the number of lesions on days 56 and 84. Subjects will be randomly assigned in a double-blind fashion to one of three parallel treatment cohorts (5%, or 10% VDA-1102, or placebo, respectively) in a ratio of 1:1:1. To qualify for the study, subjects aged 18 (inclusive) or older must have 4-8 discrete Grade 1 or 2 AK lesions within a 25-centimeter squared area of skin on the scalp or face. The study is expected to enroll approximately 84 subjects in the US and in Israel. The first 15 subjects enrolled in the trial will be considered a "nested Phase 1b safety sub-cohort" and will undergo extensive safety evaluation on Day 7.

 

About VDA-1102 ointment

VDA-1102 is a novel, potent selective modulator of the VDAC/HK2 complex in cancer cells. The drug triggers the dissociation of this HK2 from VDAC leading, among other effects, to apoptosis and death of the malignant cells. The selective nature of VDAC/HK2 dissociation targets only cancer cells without affecting the surrounding healthy tissue. VDA-1102 is being developed as a topical ointment for treatment of pre-malignant and malignant skin conditions, such as AK, cutaneous squamous cell carcinoma (cSCC), and cutaneous T-cell lymphoma (CTCL). VDA-1102 ointment has successfully completed a Phase 1 study in healthy volunteers, and is now entering a Phase 2 study in subjects with AK. VDA-1102 is also being developed as an injectable for treatment of solid tumors.

About Actinic Keratosis

Actinic keratosis (AK) is one of the most common dermatologic conditions worldwide. It effects an estimated 58 million people in the United States alone. In 2015 the global AK market was estimated at $6.6 billion. This skin disease occurs predominantly in older males with fair skin and most often begins as a rough red patch that may progress to a thicker, scaly, and unsightly skin lesion. AK is considered by many as an early form of cSCC. Thus treatment is most commonly recommended by physicians in order to prevent cSCC. Current therapies are inadequate and pose significant disadvantage to public health. The limited tolerability of current treatment options greatly decrease the willingness of patients to be retreated and/or compliant. AK is a chronic disease for which patients often require repeat treatments. As a result patients with this prevalent condition elect to avoid treatment, seeking medical help only later, after their lesions have become esthetically intolerable or have advanced to malignant cSCC tumors.  

About Vidac Pharma

Vidac Pharma is an innovative clinical stage oncology focused pharmaceutical company, developing novel drugs to help people suffering from a range of oncologic and dermatologic diseases. Vidac’s breakthrough technology targets the VDAC/HK2 system that is unique to malignant cells. The mechanism-of-action of these drugs leads to selective apoptosis of cancer cells without affecting the surrounding healthy tissue, leading to well tolerated and efficacious treatments. Vidac is developing VDA-1102 as a topica; treatment for AK and other skin malignancies, and as injections for treatment of solid tumors. For more information regarding Vidac Pharma, please visit www.vidacpharma.com.

Contact: Shelly Majar +972-2-5952090  

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Jerusalem, Israel, December 12, 2016 – Vidac Pharma, a clinical-stage oncology-focused pharmaceutical company, today announced that the ongoing Phase 2 study with VDA-1102 ointment, a potent selective VDAC/HK2 modulator, in actinic keratosis (AK) met a pre-determined interim analysis criterion. The drug candidate is being developed by Vidac as a first-in-class treatment for actinic keratosis, an early form of cutaneous squamous cell carcinoma (cSCC), featuring potency, safety, and tolerability at the same time.

The interim futility analysis was performed on the primary efficacy endpoint, which is reduction in the number of lesions on day 56 relative to placebo, following completion of the day 56 visit by the first 40 subjects enrolled in the trial. The interim analysis was performed by a single unblinded statistician who determined, according to a pre-defined criterion, that at least one of the treatment arms could achieve statistical significance by the end of the study. The study remains blinded and is continuing as planned.

Dr. Oren M. Becker, Vidac's President and Chief Executive Officer said, “we are pleased with the interim analysis results and are looking forward to the completion of the study in Q2 of 2017.”

About the Phase 2 Study

The Phase 2 clinical trial is multiple-center randomized, double-blind, placebo-controlled, parallel-cohorts study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of once-daily application of topical VDA-1102 ointment for 28 days in subjects with actinic keratosis. Subjects will be followed for two months after they complete treatment (through day 84). The primary and secondary efficacy endpoints for the study are reduction in the number of lesions on days 56 and 84, respectively. Subjects are randomly assigned in a double-blind fashion to one of three parallel treatment cohorts (5%, or 10% VDA-1102, or placebo) at a ratio of 1:1:1. To qualify for the study, subjects aged 18 (inclusive) or older must have 4-8 discrete Grade 1 or 2 AK lesions within a 25-centimeter squared area of skin on the scalp or face. The study is expected to enroll 90 subjects in the US and Israel. The first 15 subjects enrolled in the trial were part of a "nested Phase 1b safety sub-cohort" and underwent extensive safety evaluation on Day 7. Earlier in the trial, a safety committee consisting of 3 physicians, Board-certified in internal medicine and a medical subspecialty, reviewed the safety data from this Phase 1 sub-cohort and found no safety signals or concerns. Local skin reactions were mild to absent.

About VDA-1102 ointment

VDA-1102 is a novel, potent selective modulator of the VDAC/HK2 complex in cancer cells. The drug triggers the dissociation of this HK2 from VDAC leading, among other effects, to apoptosis and death of the malignant cells. The selective nature of VDAC/HK2 dissociation targets only cancer cells without affecting the surrounding healthy tissue. VDA-1102 is being developed as a topical ointment for treatment of pre-malignant and malignant skin conditions, such as AK, cutaneous squamous cell carcinoma (cSCC), and cutaneous T-cell lymphoma (CTCL). VDA-1102 ointment has successfully completed a Phase 1 study in healthy volunteers, and is now ongoing a Phase 2 study in subjects with AK. VDA-1102 is also being developed as an injectable for treatment of solid tumors.

About Actinic Keratosis

Actinic keratosis (AK) is one of the most common dermatologic conditions worldwide. It effects an estimated 58 million people in the United States alone. In 2015 the global AK market was estimated at $6.6 billion. This skin disease occurs predominantly in older males with fair skin and most often begins as a rough red patch that may progress to a thicker, scaly, and unsightly skin lesion. AK is considered by many as an early form of cSCC. Thus treatment is most commonly recommended by physicians in order to prevent cSCC. Current therapies are inadequate and pose significant disadvantage to public health. The limited tolerability of current treatment options greatly decrease the willingness of patients to be retreated and/or compliant. AK is a chronic disease for which patients often require repeat treatments. As a result patients with this prevalent condition elect to avoid treatment, seeking medical help only later, after their lesions have become esthetically intolerable or have advanced to malignant cSCC tumors.

About Vidac Pharma

Vidac Pharma is an innovative clinical-stage oncology-focused pharmaceutical company, developing novel drugs to help people suffering from a range of oncologic and dermatologic diseases. Vidac’s breakthrough technology targets the VDAC/HK2 system that is unique to malignant cells. The mechanism-of-action of these drugs leads to selective apoptosis of cancer cells without affecting the surrounding healthy tissue, leading to well tolerated and efficacious treatments. Vidac is also developing VDA-1102 as a topical for Ak and as an injections for the treatment of solid tumors. For more information regarding Vidac Pharma, please visit www.vidacpharma.com.

Contact: Shelly Majar +972-2-5952090 

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Jerusalem, Israel, January 1, 2017 – Vidac Pharma, a clinical-stage oncology-focused pharmaceutical company, today announced the appointment of Dr. Chaim Brickman as the company's Chief Medical Officer, and the appointment of Dr. Vered Behar as the company's Chief Science Officer. Dr. Brickman was formerly Vidac's Vice President of Medical Affairs and Dr. Behar was formerly the company's Vice President of Research and Development.

Dr. Brickman joined Vidac in 2014 as Vice President of Medical Affairs bringing with him more than 35 years of experience in medical practice, laboratory and clinical research, drug development, clinical operations, safety monitoring and regulatory experience. Chaim received his medical degree from the Albert Einstein Medical Center, internal medicine certification at Wayne State University Medical Center, and fellowship training at the National Institute of Allergy and Infectious Diseases (NIAID, NIH). After holding teaching, research, and leadership roles at the NIH, Uniformed Services Medical Center (Maryland), Wayne State University Medical Center, Sinai Hospital of Detroit’s Research Institute, and Wolfson Medical Center (Israel), Chaim held senior positions at Inotek Pharmaceuticals Corporation (USA) and Teva Pharmaceuticals (Israel) where he helped manage Phase I-III clinical trials in the US, Israel, Western Europe, Australia, India, and Eastern Europe. In addition, Dr. Brickman has chaired an Institutional Review Board in the United States and served as medical monitor for numerous international pharmaceutical companies and Contract Research Organizations.

Dr. Vered Behar joined Vidac in 2012 as Vice President of Research and Development bringing with her more than 15 years of experience in pharmaceutical research and nonclinical development. Prior to joining Vidac Pharma in late 2012, Dr. Behar served as the Vice President of Biology at Dynamix Pharmaceuticals, a private pharmaceutical company focused on the discovery and development of novel, targeted, small molecule drugs for cancer and auto-immune therapies. In that capacity, Dr. Behar led all biological and pharmacological aspects of the company’s drug pipeline including target selection, and all pre-clinical development. Prior to Dynamix, Dr. Behar worked with Third Rock Ventures as a technology scout, and before that as the Chief Scientist at Quantomix. Dr. Behar also served as a research scientist at Pfizer in Cambridge, MA. Dr. Behar earned her PhD in Molecular Pharmacology from the Division of Medical Sciences at Harvard University where she was awarded the prestigious Ryan Fellowship, and her BSc and MSc and MBA from the Hebrew University in Jerusalem.

“The appointment of Dr. Brickman and Dr. Behar as corporate Officers marks an important step in the maturation of Vidac as an integrated pharmaceutical company,” said Dr. Oren Becker the Company's President and Chief Executive Officer. “Both Chaim and Vered have contributed greatly to the company's progress to date and will no doubt continue to lead as we transition from the ongoing Phase 2 program in actinic keratosis to Phase 3 studies and additional indications.”

Dr. Vered Behar said, "the seamless interaction between our non-clinical and clinical teams gives our drugs the best possible chance to succeed."

Dr. Brickman added, "developing new oncologic agents with a promising mechanism of action with a team of talented scientists in a supportive environment make Vidac a unique, nourishing, and innovative work environment.”

About VDA-1102

VDA-1102 is a novel, potent selective modulator of the VDAC/HK2 complex in cancer cells. The drug triggers the dissociation of HK2 from VDAC leading, among other effects, to apoptosis and death of the malignant cells. The selective nature of VDAC/HK2 dissociation targets only cancer cells without affecting the surrounding healthy tissue. VDA-1102 is being developed as a topical ointment for treatment of pre-malignant and malignant skin conditions, such as AK, cutaneous squamous cell carcinoma (cSCC), and cutaneous T-cell lymphoma (CTCL). VDA-1102 ointment has successfully completed a Phase 1 study in healthy volunteers, and is now ongoing Phase 2 testing in subjects with AK. VDA-1102 is also being developed as an injectable for treatment of solid tumors.

About Actinic Keratosis

Actinic keratosis (AK) is one of the most common dermatologic conditions worldwide. It effects an estimated 58 million people in the United States alone. In 2015 the global AK market was estimated at $6.6 billion. This skin disease occurs predominantly in older males with fair skin and most often begins as a rough red patch that may progress to a thicker, scaly, and unsightly skin lesion. AK is considered by many as an early form of cSCC. Thus treatment is most commonly recommended by physicians in order to prevent cSCC. Current therapies are inadequate and pose significant disadvantage to public health. The limited tolerability of current treatment options greatly decrease the willingness of patients to be retreated and/or compliant. AK is a chronic disease for which patients often require repeat treatments. As a result patients with this prevalent condition elect to avoid treatment, seeking medical help only later, after their lesions have become esthetically intolerable or have advanced to malignant cSCC tumors.

About Vidac Pharma

Vidac Pharma is an innovative clinical-stage oncology-focused pharmaceutical company, developing novel drugs to help people suffering from a range of oncologic and dermatologic diseases. Vidac’s breakthrough technology targets the VDAC/HK2 system that is unique to malignant cells. The mechanism-of-action of these drugs leads to selective apoptosis of cancer cells without affecting the surrounding healthy tissue, leading to well tolerated and efficacious treatments. Vidac is also developing VDA-1102 as a topical for Ak and as an injections for the treatment of solid tumors. For more information regarding Vidac Pharma, please visit www.vidacpharma.com.

Contact: Shelly Majar +972-2-5952090   

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Jerusalem, Israel, June 29, 2016 – Vidac Pharma, a privately-held clinical stage pharmaceutical company developing novel small molecule therapeutics for the treatment of cancer and oncodermatology disease, announced today that it has closed a $9 million a Series A financing round. The financing was led by a new investor, Israel Biotech Fund. Existing investors, including Mivtach Shamir Holdings, also participated in the financing. Dr. Robert Spiegel and Mr. Ed Saltzman, members of Israel Biotech Fund’s Venture Advisory team, will join Vidac’s board of directors. Robert J. Spiegel, MD is former chief medical officer and senior vice president of the Schering-Plough Research Institute. Ed Saltzman is president and founder of Defined Health, a leading business development strategy consulting firm.

Vidac Pharma plans to use the proceeds to advance the development of its lead product, VDA-1102 ointment, which is in Phase 2 clinical trial in patients with actinic keratosis. Actinic keratosis (AK) is one of the most common dermatologic conditions worldwide. It effects an estimated 58 million people in the United States alone with estimated treatment costs in 2004 of $1.2 billion.

“This financing will allow us to advance the clinical development of our lead candidate VDA-1102 as well as progress our pipeline of novel therapeutics into clinical development,” said Oren M. Becker, Ph.D., president and chief executive officer of Vidac Pharma. “We are thrilled by the strong support from our existing investors, and by the addition of Israel Biotech Fund and its new board members who are highly experienced in guiding drugs through clinical development and regulatory approval to commercial success.”

Vidac pharma is dedicated to discovering and developing first-in-class medicines to help people suffering from a range of oncologic and oncodermatologic diseases. Vidac’s breakthrough technology targets the cancer-specific VDAC/HK2 system without affecting the surrounding healthy tissue. It thus holds the promise of delivering novel drugs that are both efficacious and well tolerated by patients.

“The new financing will allow Vidac Pharma to realize its vision of turning breakthrough science in the field of mitochondria and cancer metabolism into first-in-class therapies that help millions of patients suffering from cancer and related diseases.” Said Prof. Max Herzberg, Vidac’s founder and chairman of the board, who is the inventor of VDA-1102.

“We invested in Vidac because we were impressed by the pre-clinical results of the lead compound and management’s ability to build an important company in the field of oncology and oncodermatology,” said David Sidransky, M.D., co-founder & general partner at Israel Biotech Fund. “This investment is in line with our strategy of investing in leading drug discovery and development companies in Israel.”

About Vidac Pharma

Vidac Pharma is a clinical stage innovative biopharmaceutical company dedicated to discovering and developing first-in-class medicines to help people suffering from a range of oncologic and oncodermatologic diseases. Vidac’s breakthrough technology targets the VDAC/HK2 system that is unique to malignant cells. Modulating this target leads to selective apoptosis of cancer cells without affecting the surrounding healthy tissue, and thus holds the promise of delivering novel drugs that are both efficacious and well tolerated by patients. Vidac’s lead product is, VDA-1102, a selective VDAC/HK2 modulator formulated as a topical ointment. This drug successfully completed Phase 1 clinical, and is now in a Phase 2 clinical study in patients suffering from actinic keratosis. For more information regarding Vidac Pharma, please visit www.vidacpharma.com.

About Israel Biotech Fund

Israel Biotech Fund invests in Israeli and Israeli related biotechnology and pharmaceutical companies. The Fund’s goal is to generate strong returns and long term capital appreciation by funding and building sustainable, high value Israel-based biotech companies. For more information regarding Israel Biotech Fund, please visit www.IsraelBiotechFund.com.