Exhibit 99.1
July, 2005
Dear Shareholder:
It has been an extraordinarily busy and productive five months since we closed
our last financing. I remain extremely proud and amazed at our experienced
management team as they move our technology forward in a quality fashion in this
very complicated and highly regulated business.
As our focus is heavily weighted on our first product, Myodur, we have continued
to strengthen our intellectual property with on-going patent filings to protect
our future. CepTor is collaborating with some of the top academic institutions
in the country as we prepare for the initiation of our human trials in Duchenne
Muscular Dystrophy (DMD). We have some of the most renowned neurologists in the
world collaborating with us, including several who have joined our Scientific
Advisory Board (SAB). The Company has redeemed and canceled the vast majority of
Xechem's holdings (2,886,563 shares) resulting in, on an issued and outstanding
basis, a 29% accretion in ownership to you and a personal cost to me that I
obviously believe was well worth it. Our research and development strategy for
calpain inhibition was recently validated in the lead review article in the NEW
ENGLAND JOURNAL OF MEDICINE, the most highly regarded peer-reviewed journal in
the field. CepTor was featured in this month's issue of GENETIC ENGINEERING
NEWS, the most widely read bio-industry publication in the world.
Most importantly, our science and technology remain strong as we near completion
of our experiments and pre-clinical animal studies in preparation to file the
Investigational New Drug application (IND) for Myodur. The toxicology studies
are on track. The supporting data from all these efforts should begin appearing
in several scientific/medical, peer-reviewed publications next year. As
previously reported, management believes we had an extremely positive pre-IND
FDA meeting. As a result, we expect our clinical trials will be initiated in DMD
boys in a true phase I/II study, potentially saving a substantial amount of
development time.
As we have scaled up our contract manufacturing to GMP (Good Manufacturing
Practices) material, we have finalized our supply arrangements to begin human
studies. Bachem AG in Bubendorf, Switzerland is our primary manufacturer and
very skilled in peptide synthesis, including leupeptin. Sigma-Tau in Pomezia,
Italy is the leading provider of carnitine in the world and is providing that
portion of our compound. Quintiles has been contracted to develop our
formulations and is a leader in that capacity as well as others. PharmaNet,
voted number one CRO (clinical research organization) in the country by CENTER
WATCH is providing regulatory and CMC (chemistry manufacturing and controls)
consulting. The majority of our toxicology studies have been placed with WIL
Research Laboratories, one of the leading tox houses in the country. PCG Medical
Alliance is providing our bio-analytical assays and mass spectrometry analyses.
Critically important, Banyan Biomarkers is developing the assays to specifically
measure the precise biological effects of Myodur on targeted calpain inhibition.
The Company's legal regulatory guidance continues from Hyman, Phelps and
McNamara in D.C., with partner Frank Sasinowski, past Chief Counsel to the FDA
and primary author of the Orphan Drug Act, working directly with us. Needle and
Rosenberg in Atlanta and senior partner David Perryman, with years of experience
in biotech patenting, continue to spearhead our intellectual property
protection.
Please allow me a moment to elaborate on our collaborations mentioned above as
these institutions and people add an undeniable credibility to our efforts. The
institutions where we will be conducting our phase I/II clinical trials are
world renowned in general and in neurology specifically. They include such names
as Johns Hopkins, New York University (NYU), Washington University in St. Louis
and Ohio State University. Jerry Mendell, M.D., past Chairman of Neurology at
Ohio State, who is considered one of the world's leading authorities in muscular
dystrophy, represented CepTor at the FDA meeting and is a member of our SAB.
John Griffin, M.D., Chairman of Neurology at Johns Hopkins, President of the
American Neurological Association and Editor-In-Chief of NATURE NEUROLOGY has
recently joined our Board of Directors. Edwin Kolodny, M.D., Chairman of
Neurology at NYU, has also joined our SAB. An early SAB member, Lee Sweeney,
PhD, Chairman of Physiology at the University of Pennsylvania and Chief
Scientific Advisor to the Muscular Dystrophy Parent Project, has conducted some
of our critical animal studies. CepTor is both thrilled and honored to have the
privilege to work with these esteemed institutions and neurology leaders.
We continue to drive for our IND filing at year's end and hope to dose our first
patient by the end of Q1 next year. We still believe this will represent the
first potential definitive therapy ever in a DMD patient in a combined safety
and efficacy trial for this devastating disease. We are confident enough in this
effort and to bring confidence to you, the entire management team has
voluntarily tied up 80% of our own equity until we initiate a pivotal trial.
With all that is going on, these five months have seemed like the blink of an
eye and more is yet to come.
In closing, let me assure you that we remain dedicated to bringing meaningful
products to people with serious diseases to improve their lives. If we are
successful doing that, our business goals will be met. Sometimes we forget about
the potential altruistic effects of our investments, but that should not be the
case in this instance. On behalf of the Company, myself, and, I think I can say
rather confidently, any patient that we can affect positively, thank you for
your investment, your continued support and your patience.
Sincerely,
/s/ William H. Pursley
William H. Pursley
Chairman and Chief Executive Officer
