World Children's Transplant Fund: "When the children of our world die needlessly and without hope, a piece of us dies with them whether we know it or not. And when we help just one to live, we find a small piece of immeasurable, indescribably joy." -- Mark A. Kroeker, Founder, WCTF

 

 

 
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WCTF.org Transplant News

Transplant news, links, and other general medical news -- updated regularly.


Monday, May 5, 2008

 

The Heart Transplant Program

Johns Hopkins Comprehensive Transplant Center Heart Transplant Program . Overview. Patients who come to Johns Hopkins gain access to the vast resources of one of the world’s [more]

 

UM APPOINTS SIR ROY CALNE AS VISITING PROFESSOR (Bernama via Yahoo! Malaysia News)

UM APPOINTS SIR ROY CALNE AS VISITING PROFESSOR (Bernama via Yahoo! Malaysia News)
KUALA LUMPUR, May 4 (Bernama) -- Universiti Malaya today announced the appointment of Prof Emeritus Sir Roy Calne of Cambridge University as Visiting Professor of University Malaya Medical Centre (UMMC) to strengthen the centre's transplant team.

 

Vion Reports 2008 First Quarter Results

Vion Reports 2008 First Quarter Results

NEW HAVEN, Conn., May 5 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (NASDAQ:VION) today announced financial results for the three-month period ended March 31, 2008.

The Company reported a net loss of $8.2 million, or $1.14 per share, for the three-month period ended March 31, 2008, compared with a net loss of $8.0 million, or $1.20 per share, for the same period in 2007. Weighted-average common shares outstanding for the three months ended March 31, 2008 and 2007 were 7.2 million and 6.6 million, respectively.

Operating expenses were reduced by $679,000 from $7.9 million in the 2007 quarter to $7.2 million in 2008. Interest expense increased by $766,000 over the prior year as the Company's Convertible Senior Notes, issued in February 2007, were outstanding for the entire quarter in 2008.

The Company reported ending the quarter with $55.2 million in cash and cash equivalents, sufficient to fund the Company's operations through the third quarter of 2009 based on the current operating plan. The Company also announced that it will pay the interest payment due August 15, 2008 on its Convertible Senior Notes in cash.

Alan Kessman, Chief Executive Officer, commented, "We continue to work on the New Drug Application (NDA) for Cloretazine(R) (VNP40101M). It remains our plan to file the NDA with the U.S. Food and Drug Administration in 2008."

On February 20, 2008, the Company implemented a one-for-ten reverse split of all outstanding shares of its common stock and a corresponding decrease in the number of shares of authorized common stock. Share and per share amounts contained herein are provided on a post-split basis.

Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative cancer therapeutics. Vion has two agents in clinical trials. Cloretazine(R) (VNP40101M), a unique alkylating agent, is being evaluated in a Phase II pivotal trial as a single agent in elderly patients with previously untreated de novo poor-risk acute myelogenous leukemia. Clinical trials of Cloretazine(R) (VNP40101M) with temozolomide in brain tumors, and with stem cell transplantation in advanced hematologic malignancies, are also being conducted. Triapine(R), a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. For additional information on Vion and its product development programs, visit the Company's Internet web site at www.vionpharm.com.

This news release contains forward-looking statements. Such statements are subject to certain risk factors which may cause Vion's plans to differ or results to vary from those expected, including Vion's potential inability to obtain regulatory approval for its products, particularly Cloretazine(R) (VNP40101M), delayed or unfavorable results of drug trials, the possibility that favorable results of earlier preclinical studies or clinical trials are not predictive of safety and efficacy results in later clinical trials, the need for additional research and testing, the potential inability to secure external sources of funding to continue operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, and a variety of other risks set forth from time to time in Vion's filings with the Securities and Exchange Commission, including but not limited to the risks attendant to the forward-looking statements included under Item 1A, "Risk Factors" in Vion's Form 10-K for the year ended December 31, 2007. In particular, there can be no assurance as to the results of any of the Vion's clinical trials, that any of these trials will continue to full accrual, or that any of these trials will not be discontinued, modified, delayed or ceased altogether. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

-- Financial Statements Follow --

VION PHARMACEUTICALS, INC.
(A Development Stage Company)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

Three Months Ended
March 31,
(In thousands, except per share data) 2008 2007

Technology license fee revenue $14 $5

Operating expenses:
Clinical trials 2,854 3,399
Other research and development 2,259 2,513
Total research and development 5,113 5,912
Marketing, general and administrative 2,087 1,967
Total operating expenses 7,200 7,879

Loss from operations (7,186) (7,874)

Interest income 502 667
Interest expense (1,505) (739)
Other expense, net (6) (3)

Loss before income taxes (8,195) (7,949)

Income tax provision -- 6

Net loss ($8,195) ($7,955)

Basic and diluted loss per share(1) ($1.14) ($1.20)

Weighted-average number of shares of common stock
outstanding(1) 7,173 6,636

(1) Adjusted for all periods presented to reflect the Company's
one-for-ten reverse stock split effected February 20, 2008.

CONDENSED CONSOLIDATED BALANCE SHEET DATA
(Unaudited)

March 31, Dec. 31,
(In thousands) 2008 2007

Cash and cash equivalents $55,238 $61,067
Total assets 57,170 63,195
Convertible senior notes 54,556 54,275
Total liabilities 60,673 61,988
Shareholders' equity (3,503) 1,207

COMPANY CONTACT: Vion Pharmaceuticals, Inc.
Alan Kessman, Chief Executive Officer
Howard B. Johnson, President & CFO
(203) 498-4210


First Call Analyst:
FCMN Contact:


Source: Vion Pharmaceuticals, Inc.

CONTACT: Alan Kessman, Chief Executive Officer, or Howard B. Johnson,
President & CFO, both of Vion Pharmaceuticals, Inc., +1-203-498-4210

Web site:

http://www.vionpharm.com/


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Profile: Transplant News


 

Diplomat Specialty Pharmacy Develops and Launches Best-In-Class Electronic Navigator (eNAV(TM)) Patient Care System

Diplomat Specialty Pharmacy Develops and Launches Best-In-Class Electronic Navigator (eNAV(TM)) Patient Care System

SWARTZ CREEK, Mich., May 5 /PRNewswire/ -- Diplomat Specialty Pharmacy announced today that their proprietary and exclusive Electronic Navigator (eNAV(TM)) patient care system is now live and being utilized to manage their multiple sclerosis patients. The company plans to use eNAV(TM) as a disease management tool for all disease states including HIV/AIDS, Hepatitis C, Oncology, Rheumatoid Arthritis, Dermatology, Crohn's Disease, and Chronic Kidney Disease.

"Our current best-in-class patient care process is now enhanced by our new electronic system," stated Phil Hagerman, President and CEO of Diplomat. "This new technology will validate our patient care algorithms and superior care models resulting in improved patient experiences. Using eNAV(TM) we can improve access to drug, patient adherence and healthy outcomes."

For the practicing physician this means that Diplomat has expanded its services to provide clinically relevant, pharmacist based interventions to improve patient care. Physicians can expect to receive electronically scheduled Medication Histories, Symptom Management Notifications, Contraindication Warnings, Depression Screening, Non-Adherence Alerts, and more.

The eNAV(TM) system will also broaden reporting and data capabilities for physicians and health plans.

Diplomat's new electronic patient care system provides "patient-centric" guidance through many steps of patient care including: Prior Authorizations, Complete Medication History, Disease Education, Disease Symptom Management, Relapse Education, Contraindication Assessment, Laboratory Education, Drug Education, Drug Side Effect Education, and much more.

"With help from expert opinion, several leading software companies, and internal clinical support, we have designed a new course in modern healthcare technology," stated H. Brent Hubble PharmD, Manager of Clinical Program Development, and designer of the system. "eNAV(TM) is a streamline, state-of- the art patient care system that electronically houses core pieces of our pre-existing high-touch patient care models."

About Diplomat Specialty Pharmacy

Diplomat Specialty Pharmacy is a privately held health care organization focusing on complete medication management programs for patients with serious and chronic conditions. Key programs include: Oncology, HIV/AIDS, Hepatitis C, Multiple Sclerosis, Rheumatoid Arthritis and Psoriasis. Other specialty areas include Transplant, Fertility, Dialysis Medication Management, Bio- Identical Hormone Replacement Therapy and Specialty Compounding. The company's Health Services division specializes in disease management programs for Chronic Kidney Disease patients, as well as home and outpatient infusion. With locations in Flint and Grand Rapids, MI; Cleveland, OH; Chicago, IL; and Ft. Lauderdale, Florida; Diplomat services the specialty pharmacy needs of patients and physicians nationwide.

For more information contact:
Kathy Karns
kkarns@diplomatpharmacy.com
810-720-4452


First Call Analyst:
FCMN Contact:


Source: Diplomat Specialty Pharmacy

CONTACT: Kathy Karns of Diplomat Specialty Pharmacy, +1-810-720-4452,
kkarns@diplomatpharmacy.com

Web site:

http://www.diplomatpharmacy.com/


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Profile: Transplant News


 

Transplant groups oppose organ sales (Adelaide Now)

Transplant groups oppose organ sales (Adelaide Now)
A TOP doctor's call for young, healthy people to be paid $50,000 to donate organs has been rejected by organ donor groups.

 

HeartWare Receives Conditional Approval of IDE

HeartWare Receives Conditional Approval of IDE

FRAMINGHAM, Mass. and SYDNEY, Australia, May 5 /PRNewswire/ -- HeartWare Limited today announced that it had received conditional approval from the United States Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) for its lead product, the HeartWare(R) Left Ventricular Assist System (LVAS).

The granting of conditional IDE approval by the FDA enables the Company to immediately commence its U.S. clinical trial for the HeartWare(R) LVAS for use as a bridge to cardiac transplant in patients suffering from end-stage heart failure. HeartWare's Bridge-to-Transplant (BTT) clinical trial protocol incorporates a number of novel elements, the key aspects of which are as follows:

-- The primary endpoint is survival at 180 days. This survival endpoint is
specifically defined to include patients who have received a heart
transplant, patients who remain alive and supported by the device at
180 days, and "recovery" patients who have survived for a minimum of 60
days following the explant of their device. Patients are not required
to be listed for transplant at 180 days in order to be considered a
"success" under the study.
-- The study is a "pivotal trial" and therefore does not include a
feasibility or pilot phase.
-- The study includes a contemporaneous control group. Patient outcomes
will be compared to those of a matched cohort of patients recorded in
the InterAgency Registry for Mechanical Assisted Circulatory Support
(INTERMACS). INTERMACS is a U.S. national registry of patients
implanted with an FDA approved circulatory support device.
-- The trial requires the enrolment of up to 150 patients across a maximum
of 28 centers.
-- HeartWare is permitted to open up to 10 centers immediately. Once 10
patients have been enrolled and supported with the HeartWare(R) LVAS
for a mean period of 90 days, the Company will submit a clinical safety
report to the FDA for review. Enrolment will continue unabated at the
initial 10 centers during this review period. Subject to FDA approval
of the clinical safety report, enrolment can then be expanded to all 28
centers.
-- Patients enrolled in the HeartWare trial will be eligible for discharge
from hospital immediately following their implant.


"Receipt of this conditional approval of an IDE represents one of the most significant milestones since HeartWare's inception," said HeartWare Chief Executive Officer and President, Doug Godshall.

"We believe that the HeartWare(R) LVAS is poised to make a significant impact on the U.S. mechanical circulatory support market. This is reinforced by the high level of interest we are receiving from U.S. physicians, many of whom already anticipate the potential clinical advantages associated with our device's small size, pericardial placement and advanced peripheral systems. We are confident that these advantages, combined with the innovative structure of our trial and the FDA's consent to immediate patient discharge, will help encourage significant clinician support of the study.

"It is also pleasing that we are now within a month or two of generating our first revenue. As previously indicated, we expect to be able to charge for our system during the course of our U.S. clinical trial. We expect to supplement this revenue through commercial sales in Europe once we receive CE Mark later this year."

HeartWare will commence training for our initial U.S. clinical sites later this week and, in parallel, will seek investigational review board (IRB) approval for these sites while working towards satisfying the few conditions to our IDE. The Company expects to shortly release details regarding our initial sites and lead clinical investigators.

About HeartWare

HeartWare develops and manufactures miniaturized implantable heart pumps, or Left Ventricular Assist Devices (LVADs), designed to treat patients suffering from advanced heart failure. The Company is developing the industry's smaller and less invasive pumps, which it believes will be the key to unlocking the potential of a large and underserved market. The HeartWare(R) LVAD is a full-output pump designed to be implanted in the chest, avoiding the abdominal surgery generally required to implant competing devices. The pump is currently the subject of an international clinical trial involving five investigational centers in Europe and Australia. A clinical trial in the U.S. is expected to commence shortly following the receipt of conditional IDE approval in May 2008.

For further information:

http://www.heartware.com.au/

U.S. Investor Relations
Howard Leibman Matt Clawson
Director Corporate Development Partner
HeartWare Limited Allen & Caron, Inc.
Email: howard.leibman@heartware.com.au Email: matt@allencaron.com
Tel.: +61 2 9238 2064 Tel.: +1 949 474 4300


First Call Analyst:
FCMN Contact:


Source: HeartWare Limited

CONTACT: Howard Leibman, Director Corporate Development of HeartWare
Limited, +61 2 9238 2064, howard.leibman@heartware.com.au; or U.S. Investor
Relations, Matt Clawson, Partner of Allen & Caron, Inc., +1-949-474-4300,
matt@allencaron.com, for HeartWare Limited

Web site:

http://www.heartware.com/
http://www.heartware.com.au/


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Profile: Transplant News


 

University Hospitals Physician Authors Working Woman's Pregnancy Book

University Hospitals Physician Authors Working Woman's Pregnancy Book

CLEVELAND, May 5 /PRNewswire/ -- Marjorie Greenfield, M.D., obstetrician- gynecologist at University Hospitals MacDonald Women's Hospital, is hitting bookstores next week with The Working Woman's Pregnancy Book.

From pre-conception planning, infertility issues, and the physical and emotional changes of each trimester, to labor and birth, breastfeeding and adjusting to parenthood, this up-to-date guide discusses in a warm and engaging tone all subjects facing new mothers. This unique 500+ page book also covers issues of special concern to those women who hold jobs during their pregnancies, such as:

-- Is my workplace safe for my developing baby?
-- When should I tell my employer that I am expecting?
-- How can I handle the discomforts of pregnancy when I need to work?
-- What laws will protect me when I take medical leave?


Dr. Greenfield draws from her experiences as an obstetrician and a working mom, and from more than a hundred interviews with mothers ranging from factory workers to high-powered attorneys, to create a unique resource for working women.

"I wanted to write a pregnancy book that spoke to women in the workforce," said Dr. Greenfield. "Having a baby brings particular challenges to women who are trying to maintain their careers, and I wanted to provide factual information plus tips and encouraging words from moms who have been there, to help them get through."

The Working Woman's Pregnancy Book includes checklists for multitasking moms-to-be, helpful illustrations, stories and advice from experienced mothers and information on everything from planning a pregnancy to balancing life after the baby is born.

A well-known expert in her field, Dr. Greenfield is also the author of Dr. Spock's Pregnancy Guide as well as hundreds of articles for the Web. She maintains a personal web site and blog, available at www.marjoriegreenfield.com.

The Working Woman's Pregnancy Book is published by Yale University Press with ISBN 978-0-300-11324-2 (paperback). It hits bookshelves on May 8, 2008.

About University Hospitals

With 150 locations throughout Northeast Ohio, University Hospitals serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians. At the core of our Health System is University Hospitals Case Medical Center. The primary affiliate of Case Western Reserve University School of Medicine, University Hospitals Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation and the world, including cancer, pediatrics, women's health, orthopedics and spine, radiology and radiation oncology, neurosurgery and neuroscience, cardiology and cardiovascular surgery, organ transplantation and human genetics. Its main campus includes the internationally celebrated Rainbow Babies & Children's Hospital, ranked best in the Midwest and first in the nation for the care of critically ill newborns; MacDonald Women's Hospital, Ohio's only hospital for women; and Ireland Cancer Center, which holds the nation's highest designation by the National Cancer Institute of Comprehensive Cancer Center. For more information, go to www.uhhospitals.org


First Call Analyst:
FCMN Contact:


Source: University Hospitals

CONTACT: Amanda Todorovich of University Hospitals, +1-216-767-8543,
Amanda.todorovich@uhhospitals.org

Web site:

http://www.uhhospitals.org/
http://www.marjoriegreenfield.com/

NOTE TO EDITORS: Live talk-back interviews with Dr. Greenfield are available via satellite on Thursday, May 8, 2008 from 6:00 a.m. until 9:30 a.m. Call 216-844-3825 to schedule. B-roll-visuals are also available. University Hospitals Case Medical Center is equipped with a broadcast studio available for 24-7 live satellite connectivity. Contact media relations for more information - (216) 844-3825. And while Dr. Greenfield is most available on May 8, 2008 for the morning interviews, additional scheduling opportunities may be available.

-------
Profile: Transplant News


 

Australia kidney specialist sparks organ sales row (TODAYonline)

Australia kidney specialist sparks organ sales row (TODAYonline)
A man shows the scar left after the removal of one of his kidneys in Manila. An Australian kidney specialist has called for organ sales to be legalised to stop patients travelling overseas to buy them on the black market

 

National Marrow Donor Program(R) Kicks off National Awareness Campaign

National Marrow Donor Program(R) Kicks off National Awareness Campaign

Drives across the country and online offer opportunity to save a life

MINNEAPOLIS, May 5 /PRNewswire/ -- With the ambitious goal of adding 46,000 new members to the marrow Registry during the two weeks surrounding Mother's Day, Thanks Mom, the National Marrow Donor Program's largest annual awareness campaign, kicks off today.

For thousands of people with leukemia, lymphoma and other life-threatening diseases, a marrow transplant offers a second chance at life. Thanks Mom, which runs through May 19, urges people to join the Registry online or in person at drives across the country.

"The first thing we want to say to everyone who joins the Registry is 'thank you'," said Jeffrey W. Chell, M.D., chief executive officer of the NMDP. "One person really can make a difference. This Mother's Day, what better way to say, 'Thanks Mom' for giving you life, than to share the gift of life with another? Every donor added to the Registry and every dollar given helps save a life."

The Thanks Mom campaign highlights dozens of searching patients nationwide -- all of whom have amazing stories of strength and survival. For example:

-- Matt and Alexandra Pearl (Mo.) are two young siblings with a
potentially fatal genetic disease called Fanconi anemia. This
Mother's Day, Matt and Alexandra will meet their donors -- two
mothers from different parts of the world who donated their marrow
to give the siblings another chance at life -- for the first time.
-- Blake LaForce (Ohio), a high school senior and star athlete, was
recently diagnosed with acute lymphoblastic leukemia (ALL). Blake's
energy and that of his teammates turned to finding a matching donor
for Blake so that he can go to college and live an active life.
-- Andrew Akin (Mo.) is a blue-eyed baby with a rare disorder of the
immune system known as hemophagocytic lymphohistiocytosis (HLH) that
affects one out of every million newborn children. The good news is
that HLH can be cured with a marrow transplant.
-- Deb Rusnock (Mich.), devoted wife and mother, was diagnosed in 2004
with acute myelogenous leukemia (AML). She prays daily that a donor
will be found so she can return to good health and to "typical mom
activities" with her daughter.


Every day, more than 6,000 patients like Matt, Alexandra, Blake, Andrew and Deb search the Registry for a life-saving donor. Seventy percent of patients will not find a match within their family, and only three in 10 patients receive the transplant that could save their lives. Increasing the number of diverse donors on the Registry is critical because patients have the best chance of finding a match within their own race.

People can take part in Thanks Mom by attending one of the hundreds of donor drives across the nation. To find a drive, visit http://www.marrow.org/ and use the zip code finder to find a drive near you. People can also register online at marrow.org and become part of the NMDP's interactive Donor Garden on marrow.org, where they can share their story and inspire others to get involved.

Anyone between the ages of 18 and 60, in good health and willing to help any patient in need is eligible to join the NMDP Registry.

About the National Marrow Donor Program

The NMDP facilitates unrelated marrow and cord blood transplants as a single point of access for a long-standing collaborative network of leading national and international medical facilities in marrow and cord blood transplantation. The NMDP connects patients, doctors, donors and researchers to the resources they need to help more people live longer and healthier lives. For more information call 1 (800) MARROW-2 or visit http://www.marrow.org/.


First Call Analyst:
FCMN Contact:


Source: National Marrow Donor Program

CONTACT: Regan Hall Reinerth, +1-612-884-8515, cell, +1-612-280-5446,
for National Marrow Donor Program

Web site: http://www.marrow.org/


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Profile: Transplant News


 

219 patients on HMC’s kidney transplant list (Gulf Times)

219 patients on HMC’s kidney transplant list (Gulf Times)
Staff Reporter AS MANY as 219 patients are on the kidney transplant waiting list of Hamad Medical Corporation as of December 2007, according to statistics provided by the Organ Transplant Committee.

 

Doctor pushes Australian organ sales (CNN.com)

SYDNEY, Australia (AP) -- An Australian kidney specialist sparked national debate Monday by suggesting the government should pay up to 50,000 Australian dollars (US$47,000; euro30,400) for kidney donations to overcome a chronic shortage. [read more]

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