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Medgenics Reports Second Quarter 2015 Financial Results - CNNMoney PDF Print
  • Initiated enrollment in peritoneal dialysis study in U.S.
  • Awarded $3.4 million grant from the Israeli Office of the Chief Scientist
  • Advanced collaboration activities with CHOP

PHILADELPHIA, Aug. 10, 2015 (GLOBE NEWSWIRE) -- Medgenics, Inc.(NYSE:MDGN) (the Company), the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of orphan diseases, today announced financial results for the three and six months ended June 30, 2015.

Management Commentary

"We are very pleased to have recently initiated enrollment in the U.S. for our MDGN-201 trial evaluating the treatment of anemia in a subgroup of end stage renal disease (ESRD) patients undergoing peritoneal dialysis," stated Mike Cola, Chief Executive Officer of Medgenics.

"We are likewise encouraged by the results of our ongoing MDGN-201 study in Israel.  We are continuing enrollment in the mid-dose cohort of the study, and we have seen promising results validating the TARGT platform in the low-dose cohort. All six low-dose patients who received TARGTEPO micro-organs have shown positive initial response to therapy at approximately 100x lower Cmax than rHuEPO (e.g., EPREX). Five of six patients maintained hemoglobin levels within their targeted range due to red blood cell production stimulated by eEPO for at least five months following implantation without receiving any injections of rHuEPO or blood transfusions, and one patient continues to remain stable without receiving any injections of rHuEPO or blood transfusions for 13 months since implantation. The data will be updated at the European Society of Gene and Cell Therapy (ESGCT) in September. Finally, the increased funding from the Israeli OCS is indicative of the positive support for the development of this novel gene therapy approach, and we greatly appreciate their continued support," stated Dr. Garry Neil, Chief Scientific Officer of Medgenics.

Moving forward, the company plans to focus on initiating small proof-of-concept studies in additional renal indications through the remainder of 2015. The initial study of end-stage renal disease (ESRD) patients undergoing peritoneal dialysis is now underway in Israel and the U.S.

"We continue to be encouraged by the breadth of the opportunities provided to us by the Children's Hospital of Philadelphia (CHOP) collaboration we signed last year. Our Precision Medicine approach of targeting therapeutics to distinct genetic populations identified at CHOP is unique and should allow us to quickly place programs into the clinic. We are still on target to announce our initial collaboration program in the 2nd half of the year, and look forward to discussing our Precision Medicine approach further at that time," stated Cola.

Second Quarter Financial Results

The Company reported financial results for the three and six months ended June 30, 2015 and the filing with the U.S. Securities and Exchange Commission (SEC) of the Company's Quarterly Report on Form 10-Q. The Form 10-Q includes unaudited interim consolidated financial statements containing the information presented below, as well as additional information regarding the Company. The Form 10-Q is available at www.sec.gov and at www.medgenics.com.

Gross research and development (R&D) expenses for the three months ended June 30, 2015 increased to $4.46 million from $1.96 million for the same period in 2014. This increase was due mainly to increased sub-contractor costs and increased stock-based compensation expenses related to options granted to research and development personnel. Net R&D expenses for the three months ended June 30, 2015 increased to $3.03 million from $0.77 million for the same period in 2014 due to the increase in gross research and development expenses offset in part by an increase of $0.25 million in the participation by the OCS.

General and administrative expenses for the three months ended June 30, 2015 were $3.89 million, increasing from $2.86 million for the same period in 2014 primarily due to increased stock-based compensation expenses related to options granted to directors and general and administrative personnel, offset in part by a decrease in professional fees.

Financial expenses for the quarter ended June 30, 2015 were $0.01 million, decreasing from $0.22 million for the same period in 2014. This decrease was mainly due to the change in valuation of the warrant liability.

Financial income for the quarter ended June 30, 2015 was $0.84 million, increasing from $0.02 million for the same period in 2014. This increase was mainly due to the change in valuation of the warrant liability.

The Company reported cash and cash equivalents of $22.01 million as of June 30, 2015.

For the quarter ended June 30, 2015 the Company reported a loss of $6.09 million or $0.24 per share, compared with a loss of $3.84 million or $0.21 per share for the comparative quarter in 2014.

Six Months Financial Results

Gross R&D expenses for the six months ended June 30, 2015 increased to $8.36 million from $4.10 million for the same period in 2014. This increase was due mainly to increased materials and sub-contractor costs and increased stock-based compensation expenses related to options granted to research and development personnel.  Net R&D expenses for the six months ended June 30, 2015 increased to $6.93 million from $2.92 million for the same period in 2014 due to the increase in gross research and development expenses offset in part by an increase of $0.25 million in the participation by the OCS.

General and administrative expenses for the six months ended June 30, 2015 were $7.84 million, up from $5.96 million for the same period in 2014 primarily due to increased stock-based compensation expenses related to options granted to directors and general and administrative personnel, offset in part by a decrease in professional fees.

Financial expenses for the six months ended June 30, 2015 decreased to $0.26 million from $0.34 million for the same period in 2014, mainly due to the change in valuation of the warrant liability.

Financial income for the six months ended June 30, 2015 was $0.02, similar to the comparative period in 2014.

For the second quarter of 2015 the Company reported a net loss of $15.01 million or $0.60 per share, compared with a net loss of $9.20 million or $0.49 per share for the second quarter of 2014.

About Medgenics

Medgenics is developing the TARGT™ (Transduced Autologous Restorative Gene Therapy) system, a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides using ex vivo gene therapy and the patient's own tissue for the treatment of orphan and rare diseases. For more information, visit the Company's website at www.medgenics.com. 

Forward-looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.

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         Medgenics, Inc.
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Surgery Ups Survival in Cancer Patients with Kidney Metastases - Renal and Urology News PDF Print
August 10, 2015 Surgery Ups Survival in Cancer Patients with Kidney Metastases - Renal and Urology News
Surgical intervention in select patients with oligometastatic disease and good performance status should be considered, the researchers stated.

Patients with non-renal primary cancers that metastasize to the kidneys appear to have better survival if they undergo surgical treatment, new findings suggest.

A team at the University of Texas MD Anderson Cancer Center in Houston led by Jose A. Karam, MD, conducted a retrospective study of 151 patients diagnosed with a primary non-renal malignancy accompanied by renal metastases. Patients had a median age of 56.7 years.

The most common presenting symptoms were flank pain (30%), hematuria (16%), and weight loss (12%). The most common primary tumor site was the lung (43.7% of cases). The median overall survival (OS) from primary tumor diagnosis was 3.08 years, and the median OS from the time of metastatic diagnosis was 1.13 years, Dr. Karam's group reported online ahead of print in BJU International. For surgically-treated patients, median overall survival from primary tumor diagnosis and metastatic diagnosis was 4.81 and 2.24 years, respectively.

“Since renal metastases appear early in the metastatic process and survival appears to be longer in patients treated with surgery, surgical intervention in carefully selected patients with oligometastatic disease and good performance status should be considered,” the authors concluded. “A multidisciplinary approach, with input from urologists, oncologists, radiologists and pathologists, is needed to achieve the optimum outcomes for this specific patient population.”

The authors acknowledged that selection bias could explain the better survival outcomes observed in the surgery patients because “patients undergoing surgery with curative intent are likely to be those with minimal metastatic disease and good performance status.” A difference in systemic therapies used in the surgery patients also could explain the better observed outcomes in this cohort. 

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Shares of NxStage Medical, Inc. (NASDAQ:NXTM) Rally 25.98% - News Watch International PDF Print

Shares of NxStage Medical, Inc. (NASDAQ:NXTM) rose by 25.98% in the past week and 24.16% for the last 4 weeks. In the past week, the shares have outperformed the S&P 500 by 27.57% and the outperformance increases to 24.1% for the last 4 weeks.

Nxstage Medical, Inc. is up 8.24% in the last 3-month period. Year-to-Date the stock performance stands at 0.33%. The company shares have rallied 31.03% in the past 52 Weeks. On April 27, 2015 The shares registered one year high of $19.63 and one year low was seen on September 16, 2014 at $11.5. The 50-day moving average is $14.61 and the 200 day moving average is recorded at $16.71. S&P 500 has rallied 7.26% during the last 52-weeks. The company has received recommendation from many analysts. 5 analysts have rated the company as a strong buy. The shares have been rated as hold from 1 Wall Street Analysts. 1 analysts have suggested buy for the company.1 analyst has also rated it as a strong sell. On a different note, The Company has disclosed insider buying and selling activities to the Securities Exchange, The Securities and Exchange Commission has divulged that Turk Joseph E Jr, (President) of Nxstage Medical, Inc., had unloaded 2,000 shares at an average price of $13.86 in a transaction dated on July 22, 2015. The total value of the transaction was worth $27,720. NxStage Medical, Inc. (NASDAQ:NXTM) : On Friday heightened volatility was witnessed in NxStage Medical, Inc. (NASDAQ:NXTM) which led to swings in the share price. The shares opened for trading at $16.52 and hit $18.27 on the upside , eventually ending the session at $17.99, with a gain of 8.05% or 1.34 points. The heightened volatility saw the trading volume jump to 2,136,981 shares. The 52-week high of the share price is $19.63 and the company has a market cap of $1,141 million. The 52-week low of the share price is at $11.5 . NxStage Medical, Inc. (NxStage) is a medical device company that develops, manufactures and markets products for the treatment of kidney failure, fluid overload and related blood treatments and procedures. The Companys primary product is the NxStage System One (System One). It also sells needles and blood tubing sets primarily to dialysis clinics for the treatment of end-stage renal disease (ESRD). It operates in two segments: System One and In-Center. It distributes its products in three markets: home, critical care and in-center. In the System One segment it derives its revenues from the sale and rental of the System One and PureFlow SL equipment, and the sale of disposable products in the home and critical care markets. In the In-Center segment, it derives its revenues from the sale of blood tubing sets and needles for hemodialysis primarily for the treatment of ESRD patients at dialysis centers and needles for apheresis, which is referred to as the in-center market. NO COMMENTS LEAVE A REPLY Cancel reply

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Predictors of ECD Kidney Transplant Long-Term Outcomes Identified - Renal and Urology News PDF Print
August 10, 2015 Predictors of ECD Kidney Transplant Long-Term Outcomes Identified - Renal and Urology News
The main independent determinants are circulating donor-specific anti-HLA antibody and cold ischemia time.

Circulating donor-specific anti-HLA antibody (DSA) and longer cold ischemia time independently predict worse long-term transplantation outcomes among recipients of expanded criteria donor (ECD) kidneys, according to French investigators.

In a large, prospective study, a team led by Alexandre Loupy, MD, of the Paris Translational Research Centre for Organ Transplantation, Paris Descartes University, found that, compared with ECD kidney recipients who did not have circulating DSA on the day of transplantation (ECD/DSA-), recipients who did (ECD/DSA+) had significantly lower graft survival rates at 7 years (44% vs. 85%). Antibody mediated rejection was the main cause of graft loss in the ECD kidney recipients with circulating DSA, the researchers reported online in the British Medical Journal.

ECD/DSA+ recipients had a significant 4.4-fold increased risk of graft loss compared with ECD/DSA- recipients and a 5.6-fold increased risk of graft loss compared with all other transplant therapies.

ECD/DSA- recipients experienced a 41% improvement in graft survival at 7 years compared with ECD-DSA+ recipients, according to the investigators.

When the researchers performed a Cox analysis in the ECD kidney group, they found that a cold ischemia time of 12–24 hours and 24 hours or longer were associated with a significant 2.49 and 3.77-fold increased risk of graft loss, respectively, compared with a cold ischemia time of less than 12 hours.

The researchers concluded that circulating DSA and cold ischemia time are the main independent determinants of outcome from ECD kidney transplantation.

“Although circulating DSA is known to impair allograft outcomes, its specific impact, the amplitude of its effect, and its independence from other relevant predictors have not been addressed in the ECD population,” Dr. Loupy told Renal & Urology News. “Our data suggest that ECD kidneys may be particularly vulnerable to the effect of DSA injury and cold ischemia time.”

The study's principal cohort included 2,763 kidney recipients; of these, 916 received ECD kidneys and 1,847 received kidneys from standard criteria donors (SCD). The median follow-up time after transplantation for the overall cohort was 5.54 years, but was shorter for ECD kidney recipients than SCD kidney recipients (5.24 vs. 5.72 years).

ECD allograft survival at 7 years improved significantly with screening and transplantation in the absence of circulated DSA and with cold ischemia times of less than 12 hours.

“Our results support the implementation of active ECD specific allocation policies for avoiding DSA, decreasing cold ischaemia time, and performing adequate recipient matching,” the authors concluded. “In the present study, exclusive allocation of ECD kidneys to patients without circulating DSA would have translated to a 544.6 allograft life years saved during the nine years of study inclusion time.”

As a result of study findings, Dr. Loupy said his practice plans to allocate ECD kidneys exclusively to recipients without circulating anti-HLA DSA and expand the indications for using machine perfusion for ECD kidneys due to the deleterious effect of prolonged cold ischemia time.

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Shares of Fresenius Medical Care Corporation (NYSE:FMS) Rally 1.61% - American Trade Journal PDF Print

Shares of Fresenius Medical Care Corporation (NYSE:FMS) appreciated by 1.61% during the past week but lost 2.9% on a 4-week basis. The shares have outperformed the S&P 500 by 2.9% in the past week but underperformed the index by 2.94% in the last 4 weeks.

Fresenius Medical Care AG & Co. KGAA has dropped 1.93% during the last 3-month period . Year-to-Date the stock performance stands at 13.05%. The company shares have rallied 19.84% in the past 52 Weeks. On June 4, 2015 The shares registered one year high of $44.34 and one year low was seen on October 16, 2014 at $32.4. The 50-day moving average is $42.47 and the 200 day moving average is recorded at $41.34. S&P 500 has rallied 7.26% during the last 52-weeks. The company has received recommendation from many analysts. 2 analysts have rated the company as a strong buy. The shares have been rated as hold from 4 Wall Street Analysts. 1 analysts have suggested buy for the company. Shares of Fresenius Medical Care Corporation (NYSE:FMS) ended Friday session in red amid volatile trading. The shares closed down 0.29 points or 0.69% at $41.56 with 90,066 shares getting traded. Post opening the session at $41.04, the shares hit an intraday low of $40.93 and an intraday high of $41.58 and the price vacillated in this range throughout the day. The company has a market cap of $25,950 million and the number of outstanding shares have been calculated to be 624,394,000 shares. The 52-week high of Fresenius Medical Care Corporation (NYSE:FMS) is $44.34 and the 52-week low is $32.4. Fresenius Medical Care AG & Co KGaA is a Germany-based kidney dialysis company that operates in the fields of dialysis care and dialysis products for the treatment of end-stage renal disease (ESRD). Its dialysis business is vertically integrated and offers products and services for the entire dialysis value chain, providing dialysis treatment at dialysis clinics it owns or operates and supplying these clinics with a range of products. The Company offers two types of dialysis treatment: Hemodialysis (HD), where the machine controls the blood from the patient through a special filter, the dialyzer, and Peritoneal Dialysis (PD), where the patients peritoneum is used as a dialyzing membrane. Its dialysis product portfolio includes chronic hemodialysis, home dialysis, renal pharmaceuticals, acute therapy, liver support, therapeutic apheresis, therapy support and water technology, among others. In addition, the Company sells dialysis products to other dialysis service providers.

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