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):
June 25, 2001
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 June 29, 2001, the Company began mailing its 2000 Annual Report to
shareholders. Included in the 2000 Annual Report is a letter to our
shareholders. The text of the letter is as follows:
To Our Shareholders:
We have made good progress in most of our product development programs over
the last year. However, we recently reported inconclusive results from a Phase
2/3 clinical trial of NeuroCell(TM)-PD for the treatment of Parkinson's disease.
Although treated patients showed significant clinical improvement from baseline
after transplantation, there was also improvement in the imitation surgery
control patients. Thus, the treatment group was not significantly improved over
the control group. Several treatment group patients, however, showed marked
improvement as measured by the Unified Parkinson's Disease Rating Scale (UPDRS)
which was the primary endpoint in the clinical trial. We are continuing to
analyze the clinical data to determine if it would be possible to prospectively
identify patients that may show marked improvement after cell transplantation.
In addition, we are evaluating the enrolled patients subsequent to being
informed whether they received neural cells or imitation surgery.
Our other product development programs have not been affected by the
NeuroCell(TM)-PD results, and we are moving forward with clinical trials. As of
June, 2001 we had transplanted autologous human muscle cells into the hearts of
four patients with heart disease as part of a Phase 1 clinical trial. Two of
these patients were transplanted in conjunction with implantation of a
ventricular assist device and two were transplanted in conjunction with a
coronary artery bypass procedure. Patients with ventricular assist devices are
expected to receive a future heart transplant, at which time we plan to
histologically examine their hearts and may be able to determine survival and
integration of the transplanted muscle cells. This clinical trial is being
conducted at leading cardiac research centers including Temple University,
University of Michigan, UCLA, and The Cleveland Clinic.
We have recently transplanted fetal porcine spinal cord cells into three
patients that were paralyzed due to spinal cord damage. While it is too early to
determine whether these patients' sensation and movement have improved, the
transplantation appears to have been well-tolerated in all three patients. We
plan to transplant three more patients to complete the Phase 1 clinical trial.
In addition, we plan to complete a Phase 1 clinical trial using fetal
porcine inhibitory neurons to treat epilepsy and to begin transplanting fetal
porcine neurons into the spinal cord of patients suffering from chronic
intractable pain.
We are also working to resume our clinical trial to treat chronic stroke
patients with fetal porcine neural cells. This trial is currently on hold, but
we have reached an understanding with the FDA that should allow us to transplant
additional patients and complete our Phase 1 clinical trial. Four of the five
transplanted patients continue to show improvement.
Our net loss for the year was $3.5 million and we ended 2000 with cash and
investments of $54.6 million. Our controlled rate of spending should allow us to
continue with our currently planned clinical trials to determine safety and
preliminary efficacy of our product candidates.
We continue to believe that cell transplantation products, even for complex
conditions such as Parkinson's disease, will be successfully developed and will
significantly improve the quality of life for people suffering from numerous
intractable diseases. Inevitably, as we have seen with the NeuroCell(TM)-PD
clinical trial, there will be disappointments along the way. We view these
situations as learning experiences which will ultimately maximize our chances of
success. At Diacrin we will continue to work hard to turn our pioneering cell
transplantation research into products. I look forward to keeping you informed
of our progress.
/s/ Thomas H. Fraser
Thomas H. Fraser, Ph.D.
President and CEO
June 25, 2001
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
product 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, 2001 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 June 25, 2001, the date
of the letter to the Company's shareholders. 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: June 29, 2001 DIACRIN INC.
/s/ Thomas H. Fraser
By: -----------------------------
Thomas H. Fraser, Ph.D.
Chief Executive Officer