The International Council on Infertility Information Dissemination, Inc

REPROMEDIX EXPANDS CYSTIC FIBROSIS TEST OFFERINGS

REPROMEDIX EXPANDS CYSTIC FIBROSIS TEST OFFERINGS

Enhancement of CF Test Augments Genetic Testing Capabilities

 

WOBURN, Mass., January 10, 2005 -- Repromedix has expanded its genetic testing capabilities with the addition of the CF-48 test for Cystic Fibrosis.  This advanced assay simultaneously screens for 42 cystic fibrosis transmembrane conductance regulator (CFTR) gene mutations and six variants (polymorphisms.) The gene mutations include the 25 recommended by the American College of Obstetricians & Gynecologists (ACOG) in addition to 15 of the world’s most common and North American-prevalent mutations.

 

Craig Sockol, Repromedix President and CEO said that with the enhancement of its cystic fibrosis test, “Repromedix is improving accuracy and reducing turn-around time by 50% or more.” The CF-48 test is based on the Universal Array platform from Tm Bioscience, and operates on the Luminex xMAP system. The FDA-approved Luminex instrument allows Repromedix lab technicians to “multiplex” or analyze up to 100 assays simultaneously using very small sample volumes. “By adding an advanced CF test on the Luminex platform, we are providing significant benefit to our physician clients,” said Sockol.

 

Sockol added that his firm was invested in expanding its portfolio of genetic tests. “Repromedix is committed to bringing the benefits of scientific breakthroughs in genetic testing to our clients,” said Sockol.  “It is a natural extension of our company’s focus on advanced reproductive diagnostics.”

 

Cystic Fibrosis is the most common lethal genetic defect in Caucasian populations, affecting approximately 30,000 adults and children in North America. With every pregnancy between two parent carriers, there is a 1 in 4 chance a child will inherit CF and a 1 in 2 chance of being a carrier of the disease. This prevalence led ACOG, the American College of Medical Genetics, and the National Institutes of Health to recommend in 2001 that couples who are pregnant or considering pregnancy should be CF carrier tested.

 

About Repromedix

Based in Woburn, Mass., Repromedix (www.repromedix.com) is the leading national laboratory specializing in advanced reproductive testing. By taking an interdisciplinary approach to clinical testing, the company helps doctors find solutions to their most difficult cases of female and male infertility, recurrent pregnancy loss, and high-risk pregnancy. The company was founded in 1994 by CEO Craig Sockol and serves physicians and their patients throughout the United States and Canada.

 

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Julie Dennehy

Dennehy Public Relations

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HALOZYME THERAPEUTICS INCREASED FERTILIZATION WITH CUMULASE

COPENHAGEN, DENMARK, June 22, 2005 -Halozyme Therapeutics, Inc. (AMEX: HTI), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, and Reproductive Biology Associates, one of the leading IVF centers in the U.S., announced today results from clinical trials showing increased fertilization rates in oocytes (eggs) that were treated with Cumulase™ prior to in vitro fertilization (IVF) using the intracytoplasmic sperm injection (ICSI) procedure.  The data were presented today by Z. Peter Nagy, M.D., Ph.D., Scientific and Laboratory Director of Reproductive Biology Associates in Atlanta, Georgia, at the 21st Annual Meeting of the European Society of Human Reproduction & Embryology (ESHRE) in Copenhagen.

 

Dr. Nagy presented clinical studies comparing Cumulase to a currently used slaughterhouse-derived hyaluronidase extract in the preparation of human oocytes prior to the ICSI procedure.  The study, conducted by Dr. Nagy at Reproductive Biology Associates, revealed that Cumulase treated oocytes demonstrated significantly increased fertilization rates over oocytes exposed to the standard bovine-derived hyaluronidase extract. The study involved 26 patients and 402 oocytes. The rate of fertilization following ICSI in eggs treated with Cumulase was 81.4 percent (162 fertilized eggs out of 199) vs. 71.9 percent (146 fertilized eggs out of 203) in eggs treated with the traditional bovine-derived extract, a 13 percent increase in fertilization rate.  The range of average ICSI fertility rates in U.S. fertility clinics is currently 70 to 75 percent.

 

"These data are extremely encouraging," said Dr. Nagy.  "In addition to the higher fertility rates, we found better embryo quality for transfer following treatment with Cumulase compared to the bovine-derived hyaluronidase extracts.  Increased fertilization rates along with the better quality embryos for transfer are significant findings for the IVF community." 

 

"We are very excited about the data," said Jonathan Lim, MD, Halozyme's Chairman and CEO. "In addition to providing a safer, purer and more reliable alternative to slaughterhouse-derived enzymes, the data show that the use of Cumulase may also result in higher fertility rates compared to the standard of care.  Patients are generally unaware of the use of bovine or ovine materials used in ICSI and we believe that Cumulase provides them, in addition to IVF professionals, with an attractive alternative." 

 

Cumulase is an ex vivo formulation of rHuPH20 (recombinant human PH20 hyaluronidase) that may replace bovine and ovine extracts currently used for the preparation of oocytes prior to IVF during the process of ICSI, in which the enzyme is an essential component.  The enzyme removes the hyaluronic acid that surrounds the oocyte, allowing the clinician to then perform ICSI, injecting the sperm into the oocyte.  Cumulase provides the IVF specialist with a safer, purer and more effective alternative to slaughterhouse-derived extracts. 

 

The total Cumulase market consists of an estimated 500,000 ICSI cycles worldwide in 2005, with nearly 90,000 of those performed in the U.S. Halozyme received CE Mark approval of Cumulase in December 2004 to market the product throughout the E.U.   In April 2005, Halozyme received 510(k) clearance from the FDA to market the product in the U.S.  Cumulase is the first and only recombinant human hyaluronidase product approved for cumulus removal in the IVF process.  The company has signed agreements with Cook Ob/Gyn Incorporated, MediCult A/S, and MidAtlantic Diagnostics, Inc., to distribute Cumulase worldwide. 

 

About Reproductive Biology Associates
Reproductive Biology Associates (RBA) (www.rba-online.com), established in 1982, provides emerging reproductive technology to patients who had not achieved pregnancy through conventional diagnostic and therapeutic measures.  From its inception, RBA has been a leader in the development and refinement of clinical procedures and scientific techniques, which enhance pregnancy outcomes.  RBA was the first IVF program in the world to report a baby born with the aid of a micromanipulation technique known as partial zona dissection or PZD in 1988.  In 1993, RBA became the first center in the U.S. to achieve a pregnancy and birth through intracytoplasmic sperm injection (ICSI).  Subsequently, RBA was one of the first IVF centers in the U.S. to report success with sperm retrieved through testicular sperm aspiration.  RBA was the third IVF program in the United States to achieve a pregnancy from a frozen embryo, and in 1997, was the first clinic in the Western Hemisphere to achieve a birth through oocyte cryopreservation.  In 2004, RBA developed a new process for Intrauterine Insemination utilizing Platelet Activating Factor (PAF).
 
RBA has been featured in the media extensively worldwide, including:  Time, People, Newsweek, U.S. News & World Report, The Wall Street Journal, The New York Times, Dateline NBC, 20/20, Good Morning America, The Today Show, CNN, BBC and hundreds of other print and broadcast outlets.

 

About Halozyme Therapeutics, Inc.
Halozyme is a development stage biopharmaceutical company dedicated to developing and commercializing recombinant human enzymes for the infertility, ophthalmology, and oncology communities. The company's portfolio of products under development is based on intellectual property covering the family of human enzymes known as hyaluronidases. Halozyme's recombinant human enzymes may replace current animal slaughterhouse-derived enzymes that carry potential risks of animal pathogen transmission and immunogenicity. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic biologic.

 

Safe Harbor Statement 
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the Company's products and the market sizes for these products) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning.  Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions.  These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-KSB, 10-QSB and other filings with the Securities and Exchange Commission.

 

HALOZYME THERAPEUTICS ANNOUNCES LAUNCH OF CUMULASE

Media Contacts
Kathy Sweeney / Joleen Schultz
Mentus 
(858) 455-5500, x230/x215
kwitz@mentus.com
jschultz@mentus.com

 

 

SAN DIEGO, June 20, 2005 - Halozyme Therapeutics, Inc. (AMEX: HTI), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced the worldwide market launch of Cumulase  for the treatment of oocytes to facilitate certain in vitro fertilization (IVF) procedures.  The active pharmaceutical ingredient in Cumulase is the first and only recombinant human hyaluronidase approved in the United States and in the European Union (EU) for cumulus removal in the IVF process.  Halozyme received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in April 2005.  Halozyme also received CE Mark approval of Cumulase in December 2004 to market the product throughout the EU.

 

"We are thrilled to launch our first product and to offer IVF specialists a safer, purer and more reliable alternative to animal-derived extracts," said Jonathan Lim, MD, Halozyme's Chairman and CEO.  "This achievement validates our team's ability to develop and commercialize products based on recombinant human hyaluronidase.  We will market Cumulase throughout the U.S. and the European Union, and in other select countries in Asia."

 

Cumulase is an ex vivo formulation of rHuPH20 (recombinant human PH20 hyaluronidase) to replace bovine and ovine extracts currently used for the preparation of oocytes prior to IVF during the process of intracytoplasmic sperm injection (ICSI), in which the enzyme is an essential component.  The enzyme removes the hyaluronic acid that surrounds the oocyte, allowing the clinician to then perform ICSI, injecting the sperm into the oocyte.  Cumulase provides the IVF specialist with a safer, purer and more reliable alternative to slaughterhouse-derived extracts.

 

The total Cumulase market consists of an estimated 500,000 ICSI cycles worldwide in 2005, with nearly 90,000 of those performed in the U.S.  The company has signed agreements with MediCult A/S and MidAtlantic Diagnostics, Inc., to distribute Cumulase worldwide in 1X ready-to-use and 10X concentrate product presentations, respectively.  In February, Halozyme signed a commercial manufacturing supply agreement with Avid Bioservices to manufacture the recombinant human enzyme under current good manufacturing practices (cGMPs). 

 

About Halozyme Therapeutics, Inc.

Halozyme is a development stage biopharmaceutical company dedicated to developing and commercializing recombinant human enzymes for the infertility, ophthalmology, and oncology communities. The company's portfolio of products under development is based on intellectual property covering the family of human enzymes known as hyaluronidases. Halozyme's recombinant human enzymes may replace current animal slaughterhouse-derived enzymes that carry potential risks of animal pathogen transmission and immunogenicity. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic biologic.

 

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the marketing of Cumulase) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning.  Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions.  These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-KSB, 10-QSB and other filings with the Securities and Exchange Commission.

 

###

 

 

Press Release: Peoria Fertility Clinic Helps Give

Peoria Fertility Clinic Helps Give

the Gift of Life to an Indiana Couple
(Warning: Family Photo at the end)

 

 

(March 10, 2006 – Peoria, IL)  An Indiana couple are the newest beneficiaries of a charitable program that helps prospective parents that are struggling with infertility. Michelle and Randy Mittman of Brownsburg, Indianabecame the parents of a baby boy on February 16th with the assistance of Dr. Kathy Trumbull of Peoria and a special scholarship program created by INCIID(pronounced “inside”), the International Council on Infertility Information Dissemination.

 

The scholarship program, called From INCIID the Heartprovides IVF services to couples who would not otherwise be able to afford them. Couples for whom IVF is medically indicated can submit an application, financial information and an essay to INCIID. Once processed, applications are turned over to a volunteer committee that selects the recipients who will receive treatment.  IVF services are donated by a number of participating infertility practices across the country.   

 

Due to certain medical factors, many couples’ only hope for conception is through In Vitro Fertilization (IVF), a process by which eggs are extracted from the female partner, fertilized in a laboratory and returned to her uterus.  With an average cost of $10,000-$15,000 per cycle, IVF is out of reach for many prospective parents.    

 

The Mittmans tried unsuccessfully for 7 years to have a baby.  Michelle had been through extensive surgery to address reproductive issues.  At age 22, an ovarian cyst forced her to have her right fallopian tube and ovary removed.  Adhesions resulting from the operation required several additional surgeries.  Between surgeries, they tried fertility medications to stimulate Michelle’s remaining ovary to produce multiple eggs, thereby increasing their chances for conception. After a total of 10 unsuccessful rounds of fertility medications over several years, they were told that their only hope for having a baby was through In Vitro Fertilization.  Because of the cost of IVF, they had ruled this option out until they heard about the From INCIID the Heart program

 

The Mittmans applied to the program in the Summer of 2004.  After being passed up initially, they were eventually selected in 2005 and traveled from their home in Brownsburg, Indiana to Peoria last May for treatment with Dr. Kathy Trumbull at the Sher Institute for Reproductive Medicine – the nearest participating IVF practice.  Following their first IVF treatment cycle with Dr. Trumbull, they learned that Michelle was pregnant.  “Needless to say, we were absolutely thrilled,” Michelle said.  “After 7 years of trying, I couldn’t believe we were finally going to have a baby.”  On February 16th, Michelle gave birth to a healthy baby boy, whom they named Samuel Aidan.

 

“We just loved working with Dr. Trumbull and the staff at the Sher Institute,   They were great during our treatment, and they even called to check on us throughout the pregnancy,” Michelle said.  “We’re so grateful to everyone at INCIID and Dr. Trumbull’s office for helping make our dreams come true.”

 

Dr. Trumbull, who has donated a number of IVF treatment cycles to the INCIID program was thrilled for the Mittmans as well.  “They are such a deserving couple and have been through so much to get to this point, I was happy to be able to help them,” she said.  “Seeing the joy that people feel in a situation like this is the best part of my job.”

 

Nancy Hemenway, founder and director of INCIID, is working on expanding the scholarship program further. “Michelle and Randy are a perfect example of the thousands of couples who desperately want and deserve children, but are limited by reproductive issues,” she said. “By teaming with generous IVF programs to alleviate much of the financial burden of treatment, we are able to level the playing field and help them become families.”

 

 

Heart Baby Photo 2   and    Heart Baby Photo 3

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Press Release: New Doctors with Sher Institutes for Reproductive Medicine

This article is part of the April/May 2006 INCIID Insights Newsletter

 

The Sher Institutes for Reproductive Medicine Welcome New Physicians

 

The Sher Institutes for Reproductive Medicine are proud to welcome a number of outstanding physicians that have joined the SIRMSM family over the past year.  Each of these doctors has been recruited for his expertise in state-of-the-art infertility diagnosis and treatment, his warm and compassionate manner, and his genuine desire to help couples who are struggling with infertility issues.

 

 

Alexander M. Dlugi, M.D., F.A.C.O.G.

Medical Director, SIRMSM-New Jersey

With more than 22 years’ experience in Reproductive Medicine, Dr. Dlugi has been involved in the field since the early years of IVF in the United States.  He is board certified in Reproductive Endocrinology as well as Obstetrics and Gynecology.

Prior to joining SIRMSM in 2005, Dr. Dlugi was the Director of the Reproducitve Endocrinology and Infertility Unit at Morristown MemorialHospital where he guided the construction of its IVF Center.

He previously served as Director of the Division of Reproductive Endocrinology for the Henry Ford Health System where he also established its IVF program.

Dr. Dlugi has held academic positions at Yale University School of Medicine, Harvard Medical School, Tufts University School of Medicine, the University of Michigan School of Medicine and most recently atColumbia University.  His areas of special expertise and research include Ovarian Follicular Growth and Development, Ovulation Induction, and Endoscopic Surgery.

 

 

Walid Saleh, M.D., F.A.C.O.G.

Medical Director, SIRMSM-Dallas

With more than 10 years’ experience in the field of reproductive medicine and infertility, Dr. Saleh brings his expertise and passion to the new SIRMSM-Dallas office.  Board certified in Reproductive Endocrinology as well as Obstetrics and Gynecology, he is skilled in all aspects of Assisted Reproductive Technology and is committed to addressing the individual emotional needs of his patients in the most compassionate and professional manner.   He has authored numerous scientific abstracts and articles, and has won several awards for his work.  Dr. Saleh is a member of many professional organizations and is active in teaching and lecturing on topics of Reproductive Medicine and Infertility.  His patients rave about his warm and caring personality.

 

 

Daniel Levine, M.D., F.A.C.O.G.

Medical Director, SIRMSM-Westchester

Dr. Levine possesses a wealth of knowledge in the field of infertility and Assisted Reproductive Technology.  He is the founder and former Medical Director of the Upstate University IVF Program at SUNY UpstateMedical Center in Syracuse.

Board certified in Reproductive Endocrinology as well as Obstetrics and Gynecology, Dr. Levine is a proponent of adjunctive treatment and stress reduction in the treatment of infertility.   He is the author of numerous scientific papers and has lectured extensively at national meetings and conferences.

As the father of two daughters conceived through In Vitro Fertilization, he brings a personal understanding of the physical and emotional difficulties encountered by his patients.  Dr. Levine heads the newWestchester County office of SIRMSM-New York.

 

 

Aykut Bayrak, M.D., F.A.C.O.G.

Reproductive Endocrinologist, SIRMSM-New York

Dr. Bayrak brings a passion and dedication to his work that instills confidence in his patients.  He is known for his kind and understanding manner. As a perfectionist, Dr. Bayrak is determined to help his patients achieve their dreams of having a child.

He has authored numerous scientific abstracts and articles as well as medical textbook chapters on ovarian aging and ovarian hyperstimulation syndrome.  His papers have won numerous awards at various national and international scientific meetings.

Dr. Bayrak is actively involved in teaching medical students as well as lecturing on Assisted Reproductive Technology and In Vitro Fertilization.

 

 

D. Elan Simckes, M.D.

Attending Physician, SIRMSM-St. Louis

After 10 years as an Ob/Gyn performing Assisted Reproductive Technology procedures as well as managing ongoing pregnancies, Dr. Simckes joined SIRMSM in order to devote his full energy to infertility treatment. 

With more than 15 years’ experience in infertility, he is a compassionate and dedicated physician who takes pride in helping his patients achieve their dreams of parenthood.  He has written numerous scientific papers and is a frequent guest on television and radio programs. 

Dr. Simckes’ special areas of expertise include Recurrent Pregnancy Loss, Advanced Laparoscopic Surgery, and Polycystic Ovarian Syndrome

 

 

Barry Witten, M.D., F.A.C.O.G.

Attending Physician, SIRMSM-St. Louis

Dr. Witten has devoted his medical career to the practice of Infertility treatment. His years of experience have given him the sensitivity and insight to guide couples as well as individuals during what is often an emotionally stressful time.  His medical expertise and his respect for the patient/doctor relationship are the foundation of his personal approach to patient care. 

He is board certified in Reproductive Endocrinology as well as Obstetrics and Gynecology.  As both the Director of Reproductive Endocrinology and Infertility and the Vice Chairman of the Department of Obstetrics and Gynecology at St. John's Mercy Medical Center, he is a fixture inSt. Louis reproductive medicine. 

Dr. Witten has over 20 years experience in Infertility and is an Assistant Clinical Professor at the St. Louis University Hospital School of Medicine. 

 

*****

 

As with all of the doctors at the Sher Institutes for Reproductive Medicine, you can access these physicians via the SIRMSM website discussion boards.  They are happy to answer your questions or provide information regarding your individual situation.  Also, watch for chats with these doctors in the months to come on the INCIID website.

 

With offices in Los Angeles, Orange County (CA), Sacramento, Las Vegas, Dallas, St. Louis, New Jersey, New York and Central Illinois, The Sher Institutes for Reproductive Medicine are accessible from any area of the country as well as from international locales.  The SIRMSMphilosophy of warm, compassionate, personalized reproductive care combined with leading edge A.R.T. techniques and ongoing medical breakthroughs is embraced and practiced by all SIRMSM physicians and staff.

 

 

 

 

 

 

New England Fertility Institute Press Release

This article is part of the October 2006 INCIID Insights Newsletter

 

 

Dr. Gad Lavy and the New England Fertility Institute have welcomed to its staff Ervin Jones, MD, PhD, HCLD F.A.C.O.G. Dr. Jones is a board certified Reproductive Endocrinologist with over 20 years experience in the field.  

 

Until recently, a professor at Yale Medical School and Associate Director of the Yale Fertility Center, Dr. Ervin Jones was one of the pioneers in the field of In Vitro Fertilization. A graduate of theUniversity of California, Irvine Medical School, Dr.  Ervin Jones also received a PhD degree in Reproductive Physiology from the University ofIllinois.

 

New England Fertility Institute, the first freestanding IVF center inConnecticut has established outstanding success in the state of the art treatment of infertile couples.

The founder of New England Fertility Institute, Dr Gad Lavy, is confident that their combined experience encompassing thousands of successes will consolidate New England Fertility Institute’s position as the leading fertility center in Connecticut.

 

With offices in Stamford and Hamden, Connecticut, New England Fertility Institute provides a full range of fertility diagnostic and treatment services including surgical procedures, IUI and IVF, pre-implantation genetic diagnosis (PGD) and genetic counseling, donor egg and gestational surrogacy as well as freezing of sperm, eggs, embryos and umbilical cord blood. The practice has a fully accredited surgical suite and IVF-ART laboratory.

 

To learn more about New England Fertility Institute or to schedule an appointment, please call 203-325-3200 (Stamford) or 203-248-2353 (Hamden).

 

Visit NEFI web site www.nefertility.com

 

 

 

INCIID Insights is sponsored by Sher Institutes for Reproductive Medicine.

Press Release: New Survey Reveals Most Patients Are Unaware That Slaughterhouse-Derived Animal Products Are Used in a Majority of IVF Procedures

ARLINGTON, Va., and SAN DIEGO, Oct. 26 /PRNewswire-FirstCall/ -- The International Council on Infertility Information Dissemination (INCIID) and Halozyme Therapeutics, Inc. (AMEX: HTI) , a biopharmaceutical company developing and commercializing recombinant human enzymes, today announced the results of a survey designed to determine in vitro fertilization (IVF) patients' level of awareness of lab practices surrounding intracytoplasmic sperm injection (ICSI) procedures on their eggs. While over 82 percent of the 168 survey respondents are generally aware that there are a number of procedures performed on their eggs after retrieval, only 8 percent are aware that many IVF clinics use slaughterhouse-derived animal extract products (from bovine and ovine sources) to treat eggs prior to the ICSI procedure. More than 89 percent of respondents do not know that the use of animal extract products may have a potential impact on the outcome of an IVF cycle, such as fertilization rates and quality of embryos, for example. Fifty-seven percent of IVF procedures performed in the U.S. are ICSI or include ICSI. The survey of 168 respondents was provided online to INCIID members over a two-month period.

 

"We were surprised by the lack of information or choice available to patients about IVF lab procedures," said Linda Davies INCIID Accounts Representative. "INCIID promotes the sharing of information about IVF and encourages patients to ask about alternative lab products that may impact their fertilization rates and resulting clinical outcome."

 

Halozyme recently announced the publication of clinical data in the May issue of Fertility & Sterility, the official journal of the American Society for Reproductive Medicine, showing increased fertilization rates in oocytes (eggs) that were treated with Cumulase(R) prior to IVF using the ICSI procedure. In the prospective, randomized, blinded, sibling oocyte clinical trial, the per-patient rate of fertilization following ICSI in mature eggs treated with Cumulase was 85.3% versus 70.0% for eggs treated with a traditional bovine-derived extract product, representing a 22% increase in fertilization rate (p<0.05). In addition, the data showed a trend toward higher quality embryos with Cumulase (43% of excellent quality) compared to the bovine-derived extract product (25%).

 

A subsequent, randomized, blinded, parallel group, multicenter trial is currently underway to further characterize the benefits of Cumulase, including an evaluation of longer-term clinical outcomes.

 

"Patients really do have a choice regarding what products are used on their eggs," said Jonathan Lim, MD, Halozyme's President and CEO. "INCIID's survey further demonstrates the importance of continuing to educate both patients and physicians about alternatives to animal-derived products in IVF cycles. Patients are generally unaware of the bovine or ovine nature of materials used in ICSI, but should be encouraged to ask their IVF specialists about the various options available to them. Cumulase provides an animal product free alternative for patients, and we believe that more physicians will seek to offer their patients this superior alternative. In addition to providing a safer, purer and more reliable alternative to slaughterhouse-derived enzymes, the published data show that the use of Cumulase also results in higher fertilization rates."

 

Additional survey results include:

 

  *  Over 85 percent of respondents were not offered a choice as to what
     products or media was used in their IVF cycle.

  *  60 percent of respondents believe or strongly believe that they should
     be given a choice between animal products versus a human recombinant
     product in their next IVF/ICSI cycle.

  *  Over 78 percent of respondents are comfortable or very comfortable
     suggesting product alternatives with their IVF specialists.

 

About Cumulase

Cumulase is an ex vivo formulation of rHuPH20 (recombinant human PH20 hyaluronidase), which may replace bovine and ovine extracts currently used for the preparation of oocytes prior to IVF during the process of ICSI. The enzyme is an essential component of ICSI and removes the hyaluronic acid that surrounds the oocyte, allowing the clinician to then perform ICSI, injecting the sperm into the oocyte. Cumulase provides the IVF specialist with a safer, purer and more effective alternative to slaughterhouse-derived extracts.

 

The total Cumulase market consists of an estimated 500,000 ICSI cycles worldwide in 2005, with nearly 90,000 of those performed in the U.S. Halozyme received CE Mark approval of Cumulase in December 2004 to market the product throughout the European Union. In April 2005, Halozyme received 510(k) clearance from the FDA to market the product in the U.S. Cumulase is the first and only recombinant human hyaluronidase product approved for cumulus removal in the IVF process. The company has signed agreements with MediCult A/S and MidAtlantic Diagnostics, Inc. to distribute Cumulase worldwide.

 

About INCIID

The InterNational Council on Infertility Information Dissemination (INCIID -- pronounced "inside") is a nonprofit organization that helps individuals and couples explore their family-building options through information and educational programs < http://inciid.org >. In late 2004 INCIID launched the first and only National IVF Scholarship program, From INCIID The Heart. INCIID, with sponsors OrganonUSA, Sher Institutes for Reproductive Medicine, and Baby Beat, continues to put treatment into the hands of consumers who need financial help to battle infertility.

 

About Halozyme Therapeutics, Inc.

Halozyme is a biopharmaceutical company developing and commercializing recombinant human enzymes for the drug delivery, palliative care, oncology, and infertility markets. The company's portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases. Halozyme's recombinant human enzymes may replace current animal slaughterhouse-derived extracts that carry potential risks of animal pathogen transmission and immunogenicity. The company has received FDA approval for two products: Cumulase(R), the first and only recombinant human hyaluronidase for cumulus removal in the IVF process; and Hylenex for use as an adjuvant to increase the absorption and dispersion of other injected drugs. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic drug. For more information visit the Company's website at http://www.halozyme.com/.

 

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning pre-clinical data, clinical data, the potential effectiveness of products under development, the timing and nature of clinical trials for products under development, and the demand and potential market for these products, if approved by the FDA) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-KSB, 10-QSB and other filings with the Securities and Exchange Commission.

 

Halozyme Contact                  
David A. Ramsay                   
Chief Financial Officer           
(858) 794-8889                    
dramsay@halozyme.com              
    

Media Contacts 

Megan Swanland Riggs/ Joleen Schultz

Mentus

(858) 455-5500, x200/ x215

megan@mentus.com

 jschultz@mentus.com                              

 

INCIID Contact
Linda Davies
(703) 379-9178
Contact INCIID

Website: http://inciid.org
Website: http://www.halozyme.com/

 

Breakthrough Infertility Study Doubles IVF Success Rates and Opens Door to Egg Freezing

LAS VEGAS, Jan. 29 /PRNewswire/ -- A process that could markedly improve pregnancy rates from In Vitro-Fertilization (IVF) was reported in a study published in the prestigious medical journal Fertility and Sterility (F&S).

 

(See the Video) and for Information about the Web Cast

 

 "This very exciting breakthrough could more than double IVF pregnancy success rates while reducing the risk of multiple births. We are now much closer to the goal of one IVF attempt, one egg, and one embryo, yielding one healthy baby," said Dr. Geoffrey Sher, who along with Levent Keskintepe PhD , both of ReproCure, LLC and the Sher Institutes for Reproductive Medicine(SM) (SIRM) developed the process and conducted the study.
    

Attend the Web Cast Thursday Feb. 15th, 2007 at 9:30 PM ET

 

Press Release Infertility: Pregnancy from Frozen Human Egg in Connecticut

Pregnancy from Frozen Human Egg, 
Reported by New England Fertility Institute 
of Stamford and Hamden Connecticucut.

 

 

Dr. Gad Lavy M.D., F.A.C.O.G., Medical Director and Founder of the New England Fertility Institute announces a pregnancy resulting from a frozen human egg. “To our knowledge this is the first human pregnancy achieved in Connecticut from a frozen egg.”

 

To date, there have been only about 300 births resulting from frozen eggs worldwide. Human eggs are far more difficult to successfully freeze and thaw than embryos. The is in part due to the large water content of the egg that results in the formation of ice crystals on freezing.  Ice crystal formation within the egg can cause damage or destruction of the egg. Better understanding of the egg cell and improved cryopreservation procedures have led to successful freezing and thawing of human eggs.

 

Our team was able to freeze the eggs of a 25 year old donor for 6 months and then use standard IVF procedures to achieve a pregnancy in a recipient.  The pregnancy is ongoing and seems to be progressing normally

“We have crossed a significant clinical threshold with regards to successfully freezing and thawing egg”, said Dr. Ervin Jones PhD., M.D., Associate Medical Director of the New England Fertility Institute.

 

The potential applications for egg freezing are far reaching and include:
1. Freezing eggs of single women who are diagnosed with cancer and are about to have surgery or chemotherapy, which is likely to damage ovaries.
2.  Freezing the eggs of single women are concerned about the effects of aging on the quality of their eggs and their chances of achieving successful pregnancy.
3. Creating donor egg banks similar to sperm banks. Providing couples in need of egg donor a wider choice, and simplifying the procedure.
4. Limiting the number of embryos created during standard IVF.

We have stored frozen eggs from women with cancer and from women concerned about the effects of aging on their eggs.

 

 

For further information or to  arrange a tour please contact Marion Welch at 203-942-6206 

 

Do Older Women Need More Embryos?

Contact: 
Eleanor Nicoll at 202-249-4338 or enicoll@asrm-dc.org  

 

HIGHLIGHTS FROM THE 63RD ANNUAL MEETING OF THE AMERICAN SOCIETY FOR REPRODUCTIVE MEDICINE

 

 

Do Older Women Need More Embryos?

Washington, DC – Several new research studies presented at the American Society for Reproductive Medicine meeting tackled the question of how best to help older women seeking to have children. 

 

Using data collected by the Society for Assisted Reproductive Technology (SART) the SART writing group analyzed data from IVF cycles performed between 2000 and 2004. They examined records of more than 5500 cycles performed in women over age 37. They found that for 38 and 39 year olds, compared to a single embryo transfer, the use of up to two embryos increased the number of cycles leading to a live birth; however transferring more embryos did not increase the delivery rate, but did increase the number of multiple births. For women age 40, using 3 embryos did increase the delivery rate, but not the multiple-birth rate. For women aged 41 and 42, transferring more than 2 embryos did not increase the delivery rate, but did increase the number of twins.

 

Another study by that same research team evaluated more than 38,000 cycles in women over age 37. They found that for 38 and 39 year old women both delivery rates and rates of multiple-birth rates increased as the number of embryos transferred increased to 3. Transferring more than 3 embryos did not increase pregnancy rates for this age group. Forty year old patients did see an increase in pregnancy rates as well as rates of multiple gestations.

 

A team from the Robert Wood Johnson Medical School found that increasing the number of embryos transferred in patients over age 40 could increase their pregnancy rates.

 

A team of researchers in Houston and Colorado analyzed nearly 300 cycles done on 41 and 42 year old patients in their programs. They used the outcomes of those cycles to create a mathematical model that projects that cycles using up to 6 embryos for patients over age 40 would result in very few multiple gestations.

 

In Connecticut, insurance companies are required to offer coverage for infertility patients up to age 40. Researchers found that women beyond age 40 were treated successfully. The live birth rate for 43 year olds was 10% and for 44 year old patients it was 5.4%.

 

“SART is committed to collecting and using data to ensure we provide our patients the best care possible. We are constantly striving to maximize the chances for each patient to have a safe successful singleton pregnancy,” said David Grainger, MD, MPH, President of the Society for Assisted Reproductive Technology (SART).

 

O-75, Stern et al, Optimizing the Number of Cleavage Stage Embryos to Transfer on Day 3 in Women 38 and Older: A SART Database Study

 

O-167, Optimizing the Number of Blastocyst Stage Embryos to Transfer in Women 38 and Older: A SART Database Study

 

P-110, Hickman et al, Are We Justified in Transferring more Embryos in Older Women?

 

P-519, Katsoff et al, In Contrast to Younger Women, the Transfer of 2 or 3 Embryos in Women Aged 40-42 with Increases Day Three Serum Follicle Stimulating Hormone (FSH) Markedly Improves Pregnancy Rates (PRs) Jerome Check, MD, PhD presenting. 

 

P-515, Cetinkaya et al, Reproductive Outcome of Women > 43 Years Old Undergoing ART Treatment with their own Oocytes Pasquale Patrizio, MD contact for discussion.

 

The American Society for Reproductive Medicine, founded in 1944, is an organization of more than 8,000 physicians, researchers, nurses, technicians, and other professionals dedicated to advancing knowledge and expertise in reproductive biology. Affiliated societies include the Society for Assisted Reproductive Technology, The Society for Male Reproduction and Urology, the Society for Reproductive Endocrinology and Infertility, and the Society of Reproductive Surgeons. 

 

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