SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
July 25, 2002
Diacrin, Inc.
(Exact name of registrant as specified in its charter)
Delaware 0-20139 22-3016912
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(State or other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification No.)
Building 96 13th Street
Charlestown Navy Yard
Charlestown, MA 02129
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(Address of principal (Zip Code)
executive offices)
Registrant's telephone number, including area code: (617) 242-9100
N/A
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(Former name or former address, if changed since last report)
Item 9. Regulation FD Disclosure
On July 25, 2002, the Company began mailing its 2001 Annual Report to
shareholders. Included in the 2001 Annual Report is a letter to our
shareholders. The text of the letter is as follows:
To Our Shareholders:
At Diacrin, we continue to believe that cell transplantation products will
successfully address important unmet medical needs and that Diacrin
will play a leading role in developing these products. In order to meet
this challenge, we are continually evaluating our own and others' cell
transplantation technologies to help ensure that we are on the leading
edge of technology and are focusing our resources appropriately.
When Diacrin began operations over twelve years ago we focused most
of our attention on developing porcine cells for transplantation,
although we also initiated a project to transplant human muscle cells.
The development of our porcine cell product candidates has recently
experienced clinical and regulatory setbacks. While we continue to
believe that porcine cells can be developed as viable products, it is clear
that the road will be longer than any of us originally anticipated. There
are currently no signs that the challenging regulatory environment
surrounding porcine cells is going to ease. We believe that the
underlying regulatory concern stems from the possibility that porcine
endogenous retrovirus (PERV) could theoretically infect humans,
despite the fact that no human has ever been infected. We are currently
focusing most of our porcine cell development efforts on evaluating the
ability of porcine hepatocytes to ameliorate life-threatening liver failure.
In this case, the extremely low theoretical risk of PERV infection is far
outweighed by the potential benefit. We have also recently completed
patient accrual in a Phase 1 clinical trial using porcine spinal cord cells to
treat spinal cord injury. Several patients have shown significant
improvement in sensory and motor function, and we are continuing to
follow the patients in this trial. In addition, several patients in our Phase
1 stroke trial have shown sustained improvement, but the trial remains
on clinical hold.
We are now conducting clinical trials to evaluate the ability of human
muscle cells to repair damaged heart muscle. In April 2001, we and our
collaborators published the results of a muscle cell transplantation study
in the journal Circulation. This study showed that transplantation of
muscle cells after myocardial infarction in an animal model attenuated
deleterious cardiac remodeling and improved cardiac function. We are
currently conducting two Phase 1 human clinical trials using autologous
human muscle cells.
One of these trials involves transplanting muscle cells into a patient's
heart at the same time that they receive a left ventricular assist device
(LVAD). The LVAD is implanted in these patients as a bridge to heart
transplant. Once a patient receives a new heart, we are able to
histologically examine their old heart. This allows us to evaluate cell
survival and new blood vessel formation after transplantation. With five
out of a planned six patients transplanted and three hearts examined,
results to date have been encouraging. We are planning to add six more
patients with an increase in dose from 300 million to 900 million cells.
This clinical trial is being conducted at Temple University, University of
Michigan, and University of Nebraska.
A second Phase 1 clinical trial involves transplanting muscle cells into
the heart at the same time that a patient undergoes coronary artery
bypass surgery (CABG). This is a 12-patient dose escalation trial with
safety being evaluated at doses ranging from 10 million to 300 million
cells. To date, we have transplanted ten patients and plan to extend the
trial to include two more doses at 600 and 900 million cells. This clinical
trial is being conducted at Arizona Heart Institute, UCLA, The
Cleveland Clinic, and Ohio State University.
Our net loss for the year was $4.6 million and we ended 2001 with cash
and investments of $49.7 million. Our focused approach to the
development of cell transplantation products should allow us to
continue with our currently planned clinical trials to determine safety
and preliminary efficacy. As we move forward into more advanced
clinical trials, our plan is to form partnerships with other companies to
accelerate development. I look forward to keeping you informed of our
progress.
/s/ Thomas H. Fraser
Thomas H. Fraser, Ph.D.
President and CEO
This filing contains certain forward-looking statements that involve risks and
uncertainties, including statements with respect to the safety, efficacy,
potential benefits and successful development of the Company's products under
development, the importance of cell transplantation and the Company's plans
relating to its products under development. Among the factors that could cause
actual results to differ materially from those indicated by such forward-looking
statements are: the results of clinical trials with respect to products under
development; the submission, acceptance and approval of regulatory filings; the
timing of the initiation and completion of clinical trials; the Company's
ability to re-initiate a clinical trial that the FDA has put on hold; the
continuation and/or success of the Company's joint venture with Genzyme
Corporation; the scope of the Company's patent protection with respect to its
products under development; the commercial success of the Company's products
under development; the ability of the Company to attract and retain qualified
personnel; the availability of sufficient funds to continue research and
development efforts; and certain other factors. For a more detailed discussion
of these and other factors, see the Company's Quarterly Report on Form 10-Q for
the period ended March 31, 2002 as filed with the Securities and Exchange
Commission. The forward-looking statements contained in this Current Report on
Form 8-K represent the expectations of the Company as of July 25, 2002.
Subsequent events will cause the Company's expectations to change. However,
while the Company may elect to update these forward-looking statements, it
specifically disclaims any obligation to do so.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
Date: July 25, 2002 DIACRIN INC.
/s/ Thomas H. Fraser
By: -----------------------------
Thomas H. Fraser, Ph.D.
President and
Chief Executive Officer